G5-Evolution® Colonic Stent System-Uncovered

EVOLUTION® COLONIC STENT
SYSTEM - UNCOVERED
Curso Integral:
Elaboración de Dossier Técnico para el

Registro de Dispositivos Médicos.
Docente: Elizabeth Valencia A. aquí

Fecha: 20-09-2022 aquí
Integrantes:
Nombre aquí
Roxana Arauco Marin
Nombre aquí
Guissella Contreras Salhua
Nombre aquí Calzada Bustamante
Ketty María
Nombre aquí
Nombre aquí
Solicitud - Declaración Jurada
Inscripción en el Registro Sanitario de N° DE EXPEDIENTE:

Dispositivos Médicos de la Clase III (de alto
FECHA:
riesgo) (TUPA: 250)
I. INFORMACIÓN DEL SOLICITANTE:
1. CATEGORÍA DE LA EMPRESA LABORATORIO DROGUERÍA X
2. RAZÓN SOCIAL 3. NOMBRE COMERCIAL 4. R.U.C. Nº
CORPORACION FARMACEUTICA INTEGRAL S.A.C. CORFARINT 20604270300
5. UBICACIÓN Av./ Calle / Jr. 6. Nº/Mz/Lt 7. REFERENCIA
LOS PETROLEROS 170
8. URBANIZACIÓN 9. DISTRITO 10. PROVINCIA
LOS INGENIEROS LA MOLINA LIMA
11. DEPARTAMENTO 12. PAÍS 13. TELÉFONO FIJO 14. TELÉFONO MÓVIL 15. CORREO ELECTRÓNICO
LIMA PERU 980562483 direccion.tecnica@corfarint.com.pe
16. DIRECTOR TECNICO 17. REPRESENTANTE LEGAL
ROXANA ARAUCO MARIN SILVA TORRES MARCO ANTONIO
II. INFORMACIÓN DEL DISPOSITIVO MEDICO:
Dispositivo Médico: (X )
18. GRUPO DE PRODUCTO Equipo Biomédico: ( )
Equipo Biomédico de Tecnología Controlada: ( )
19. NOMBRE DEL DISPOSITIVO MÉDICO
EVOLUTION® COLONIC STENT SYSTEM UNCOVERED
20. Marca Comercial (si tuviera)
21. Nomenclatura universal (nombre común o

STENT COLÓNICO METALICO SIN RECUBRIMIENTO
nombre genérico) del DM (en español)
22. Código de Identificación (según el estándar

37847
internacional)
23. Estándar internacional utilizado GMDN
24. Origen: Nacional ( ) Extranjero ( X )
III. INFORMACIÓN DEL FABRICANTE:

25. Origen Fabricante Nacional ( ) Extranjero ( X )
26. Razón Social ó Nombre COOK IRELAND LIMITED
27. Dirección del Fabricante O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK, LIMERICK
28. País IRLANDA
29. Cuenta con BPM vigente emitido por la ANM SI N° de BPM NO X
30. Sitio de Fabricación IRLANDA
31. Dirección del Sitio de Fabricación O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK, LIMERICK 32. País IRLANDA
MODALIDAD DE FABRICACIÓN
33. Fabricación por Encargo:

Fabricado por:
Dirección del Fabricante: País:
Fabricado para:
Dirección del Fabricante: País:
34. Fabricación por Etapas:

- Acondicionado:
Dirección: País:
- Ensamblado:
Dirección: País:
- Envasado:
Dirección: País:
- Otros
Dirección: País:
DECLARACIÓN JURADA
POR EL PRESENTE DOCUMENTO YO, MARCO ANTONIO SILVA TORRES IDENTIFICADO CON DNI.
Nº07233036, REPRESENTANTE LEGAL DE LA EMPRESA CORPORACIÓN FARMACEUTICA INTEGRAL
S.A.C. CON RUC. Nº20604270300, CON DOMICILIO EN LA CALLE LOS PETROLEROS N°170, URB. LOS
INGENIEROS, LA MOLINA LIMA. DECLARO BAJO JURAMENTO QUE:
1.- EL CONTENIDO TOTAL DE LA INFORMACIÓN PROPORCIONADA POR MI REPRESENTADA EN LA
SOLICITUD-FORMATO, PARA EL DISPOSITIVO MÉDICO EVOLUTION®COLONIC STENT SYSTEM
UNCOVERED, ES ABSOLUTAMENTE CIERTO Y VERAZ.
2.- TODOS LOS DOCUMENTOS ADJUNTADOS POR MI REPRESENTADA EN MEDIOS FÍSICO Y/O CD A
LA SOLICITUD-FORMATO, SON COPIA FIEL DE LOS ORIGINALES QUE TENGO EN MI PODER.
3.- EL DISPOSITIVO MÉDICO SEÑALADO EN LA SOLICITUD-DECLARACIÓN JURADA, REUNE LAS
CONDICIONES DE CALIDAD, SEGURIDAD, EFICACIA E INOCUIDAD.
4.- LA FABRICACIÓN DEL DISPOSITIVO MÉDICO SEÑALADO EN LA SOLICITUD-DECLARACIÓN
JURADA, HA CUMPLIDO CON LAS BUENAS PRÁCTICAS DE MANUFACTURA.
5.- MI REPRESENTADA PRESTARÁ TODAS LAS FACILIDADES QUE SOLICITE LA AUTORIDAD DE
SALUD, A FIN DE COMPROBAR LA VERACIDAD DE LA INFORMACIÓN PRESENTADA, EN
CUMPLIMIENTO AL PRINCIPIO DE PRIVILEGIO DE CONTROLES POSTERIORES, DISPUESTO EN EL
ART.IV.,1.16 DEL DECRETO SUPREMO Nº004-2019-JUS QUE APRUEBA EL TUO DE LA LEY 27444, LEY
DEL PROCEDIMIENTO ADMINISTRATIVO GENERAL. POR TODO ELLO EL SUSCRITO, COMO
REPRESENTANTE LEGAL DE LA EMPRESA CORPORACIÓN FARMACEUTICA INTEGRAL S.A.C.
ASUME TODA LA RESPONSABILIDAD QUE PUDIERA DERIVAR DE LA FABRICACIÓN,
IMPORTACIÓN, EXPORTACIÓN, COMERCIALIZACION, ALMACENAMIENTO, DISTRIBUCIÓN,
DISPENSACION, EXPENDIO Y TENENCIA DEL PRODUCTO SEÑALADO EN LA SOLICITUD-FORMATO.
EN CASO DE FALSEDAD EN LA INFORMACIÓN O EN LA DOCUMENTACIÓN PRESENTADA, LA
AUTORIDAD ADMINISTRATIVA PODRÁ INICIAR LAS ACCIONES ADMINISTRATIVAS
SANCIONATORIAS, ADEMÁS DE SOLICITAR A LA PROCURADURÍA PÚBLICA DEL MINSTERIO DE
SALUD EL INICIO DE LAS ACCIONES PENALES CORRESPONDIENTES.
LIMA, 16 DE SETIEMBRE DEL 2022.
_______________________________
MARCO ANTONIO SILVA TORRES ROXANA ARAUCO MARIN
REPRESENTANTE LEGAL DIRECTOR TÉCNICO
DNI: 07233036 C.Q.F.N°: 18774
FORMATO DMIMM-001
PARTE I : DATOS GENERALES DEL DISPOSITIVO MÉDICO, SEGÚN CORRESPONDA
Instrumental
a. Tipo de Dispositivo Médico (DM) b. Registro Sanitario Nº
Material o insumo
c. Clasificación del DM según nivel de

Clase I Clase II Clase III Clase IV
riesgo1
e. Marca Comercial (si

2 EVOLUTION® COLONIC STENT SYSTEM tuviera de acuerdo al
d. Nombre del DM
UNCOVERED CLC o carta del
fabricante)
f. Nomenclatura universal (nombre STENT COLÓNICO g. Código de identificación h. Estándar internacional

común o nombre genérico) del DM METALICO SIN (según el estándar 37847 utilizado para el llenado GMDN
(en español)3 RECUBRIMIENTO internacional)3 de los literales "f" y "g"3
j. Fabricante COOK IRELAND LIMITED k. País de fabricación IRLANDA

Fabricado por (nombre y país de la empresa fabricante o laboratorio encargado
l. Por encargo (si
de la fabricación) para (nombre y país de la empresa que encarga la
corresponde)2
i. Fabricación fabricación)
ll. Otras modalidades Acondicionado Ensamblado Envasado

de fabricación (si por (nombre y país de la empresa fabricante o laboratorio que lo realiza) para
corresponde)2 (nombre y país de la empresa que lo requiere)
m. Reacondicionamiento
(nombre del laboratorio nacional que lo realiza)
(si corresponde)
n. Forma comercial Unidad Sistema Familia Set Kit Otro (especificar)
1
Verifique la clasificación a la que pertenece el dispositivo médico en la Directiva que establece los criterios para la clasificación de los dispositivos médicos en base al riesgo y regula las condiciones esenciales
que deben cumplir en el Perú.
2
Para DM importados deben coincidir con el Certificado de Libre Comercialización.
3
Según GMDN, UMDNS u otro estándar internacional reconocido.
NRO CODIGO_DESCRIPCION DESCRIPCION COMPONENTE
-Stent metálico autoexpandible, con longitud de

60 mm, diámetro del cuerpo del stent de 25 mm,
REF EVO-25-30-6-C Evolution® Colonic Stent System
1 diámetro del borde del stent de 30 mm.
REF G48029 Uncovered
-Sistema de implantación del stent, con una
longitud de 230 cm± 3cm


FORMA_PRESENTACION_GENERAL
-Envase inmediato: Bolsa de PET/PE (Polietileno
tereftalato/Polietileno), Mylar y Tyvek
-Envase mediato: Bolsa de Polietileno tereftalato/Polietileno,
Mylar y Tyvek
Nota: El stent se coloca en un tubo protector de PP
(Polipropileno), y este a su vez con el sistema de implantación
se colocan dentro de un bandeja con tapa de PETG
(Polietilenglicol tereftalato).
Mylar y Tyvek
Mylar y Tyvek
TRADUCCIÓN SIMPLE
Logo HPRA
8 de febrero de 2021
CERTIFICADO DE LIBRE VENTA
A quien corresponda
La Autoridad Reguladora de Productos Sanitarios certifica que:
1) Los productos sanitarios generales especificados en el anexo son fabricados por Cook
Ireland Limited, O'Halloran Road, National Technology Park, Limerick, Irlanda.
2) Los productos sanitarios generales especificados en la lista adjunta llevan el marcado CE
de conformidad con la normativa de las Comunidades Europeas (productos sanitarios)
de 1994 (que transpone la Directiva 93/42/CEE sobre productos sanitarios a la
legislación irlandesa) y pueden comercializarse y venderse en Irlanda.
3) No se prohíbe la exportación de los dispositivos médicos generales enumerados en la
lista adjunta.
4) La concesión de este certificado se basa en la información que dispone la Autoridad
Reguladora de Productos Sanitarios en la fecha de emisión del certificado.
Emitido a: Cook lreland Limited O'Halloran Road

National Technology Park Limerick
Irlanda.
Fecha de caducidad: 27 de mayo de 2025.
(firma)
Patrick Keating
Departamento de cumplimiento de la normativa
Autoridad reguladora de los productos sanitarios
(Sello)
Apostillado - Irlanda
Lista de dispositivos
CHBS-7- Descripción
ltem número/ Código
15 CHBS-
ENBD-10 Nasal Biliary
7-3 CHBS-
ENBD-5 Drainage Set
7-5
ENBD-5- Nasal Biliary
CHBS-7-6
C Drainage Set
ENBD-5-LIGUORY Nasal Biliary Drainage
ENBD-5- LIGUORY- Catheter Liguory Nasal
C ENBD-5- Biliary Drainage Set
LIGUORY -RT Nasal Biliary Drainage
ENBD-5-NAG Catheter Liguory Nasal
ENBD-6 Biliary Drainage Set
ENBD-6- Nagaraja Nasal Biliary
C Drainage Set Nasal
ENBD-6-LIGUORY Biliary Drainage Set
ENBD-6-LIGUORY- Nasal Biliary Drainage
C ENBD-6- Catheter Liguory Nasal
LIGUORY-RT Biliary Drainage Set
ENBD-6-NAG Liguory Nasal Biliary
ENBD-6-NAG-C Drainage Catheter Liguory
ENBD-6.5- Nasal Biliary Drainage Set
LEUNG-4 Nagaraja Nasal Biliary
ENBD-6.5-LEUNG - Drainage Set Nagaraja
4-C ENBD-6.5- Nasal Biliary Drainage
LEUNG-7 ENBD-6.5- Catheter Leung Nasal Biliary
LEUNG-7-C ENBD-7 Drainage Set
ENBD-7-C Leung Nasal Biliary
ENBD-7-LIGUORY Drainage Catheter Leung
ENBD-7-LIGUORY- Nasal Biliary Drainage
C ENBD-7 - Set Leung Nasal Biliary
LIGUORY-RT Drainage Catheter Nasal
ENBD-7-NAG Biliary Drainage Set
ENBD-7-NAG- Nasal Biliary Drainage
C ENBD-8.5 Catheter Liguory Nasal
ENBD-8.5-LIGUORY Biliary Drainage Set
ENBD-8.5- Liguory Nasal Biliary
NAG CHBS- Drainage Catheter Liguory
10-3 CHBS- Nasal Biliary Drainage Set
10-10 CHBS- Nagaraja Nasal Biliary
10- 11 Drainage Set Nagaraja
CHBS-10 - 12 Nasal Biliary Drainage
CHBS- 10-15 Catheter Nasal Biliary
CHBS-10-5 Drainage Set
CHBS-10 -7 Liguory Nasal Biliary
CHBS-10-9 Drainage Set Nagar.aja
CHBS-11.5- Nasal Biliary Drainage
10 CHBS- Set Cotton-Huibregtse
11.5-12 Biliary Stent Set
CHBS-11.5- Cotton-Huibregtse
15 CHBS- Biliary Stent Set
11.5-5 Cotton-Huibregtse
CHBS-11.5-7 Biliary Stent Set
CHBS- 11.5- Cotton-Huibregtse
9 Biliary Stent Set
CHBS-7- Cotton-Huibregtse
10 CHBS- Bili?ry Stent Set
7-12 Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliry Stent Set Cotton-
Huibregtse Biliary Stent
Set Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
Cotton-Huibregtse
Biliary Stent Set
2/19
CHBS-7-7 CHBS-7-9 CHBS-8.5-12 Cotton-
CHBS-8.5-15 CHBS-8.5-5 CHBS- Huibregtse
8.5-7 CHBS-8.5 -9 CHBS0-10-1O Biliary Stent
CHBS0-10 - 11 Set Ctton-
- CHBS0-10-12 CHBS0-10- 12-RB Huibregtse
CHBS0-10-15 CHBS0-10-15-RB Biliary Stent
CHBS0-10 - 18 CHBS0-10-3 CHBS0-10- Set Cotton-
4 CHBS0-10-5 CHBS0-10-5-RB CHBS0- Huibregtse
10-6 CHBS0-10-7 CHBS0-10-7-RB Biliary Stent
CHBS0-10-8 CHBS0-10-9 CHBS0- 10- Set Cotton-
9-RB CHBS0-11.5-10 CHBS0 - 11.5-12 Huibregtse
CHBS0-11.5-15 CHBS0 - 11.5-18 Biliary Stent
CHBS0-11.5-5 CHBS0-11.5-5-RB Set Cotton-
CHBS0-11.5-7 CHBS0- 11.5-8 Huibregtse
Biliary Stent
CHBS0-11.5-9 CHBS0-7-10 CHBS0-7 -
Set Cotton-
12 CHBS0-7-15 CHBS0-7-4 CHBS0-7-5
Huibregtse
CHBS0-7 -7 CHBS0-7-9 CHBS0-7-18
Biliary Stent
CHBS0-8.5-1O CHBS0-8.5-12 CHBS0-
Set Cotton-
8.5-12-RB CHBS0-8.5- 15 CHBS0-8.5-
Huibregtse
18 CHBS0-8.5-5 CHBS0-8.5-5-RB
Biliary Stent
CHBS0 -8.5-7 CHBS0-8.5-7-RB CHBS0-
Set Cotton-
8.5-9 CHBS0-8.5-9- RB
Huibregtse
Biliary Stent
Cotton-
Huibregtse
Biliary Stent
Cotton-
Huibregtse
Biliary Stent
Cotton-Huibregtse Biliary Stent
w/ Radiopaque Bands Cotton-
Cotton-
Huibregts
e Biliary
Stent
Cotton-
Huibregts
e Biliary
Stent
Cotton-
Huibregts
e Billary
Stent
w/ Radiopaque Bands Cdtton-
Huibregtse Biliary Stent Cotton-
Cotton- Huibregts
Huibregts e Biliary
e Biliary Stent
Stent Cotton-
Cotton- Huibregts
Huibregts e Biliary
e Biliary Stent
Stent Cotton-
Cotton- Huibregts
Huibregts e Biliary
e Biliary Stent
Stent Cotton-
Cotton- Huibregts
Huibregts e Biliary
e Biliary Stent
Stent Cotton-
Cotton-Huibregtse Biliary Stent w/ Huibregts
Radiopaque Bands e Biliary
Cotton- Stent
Huibregts Cotton-
e Biliary Huibregts
Stent e Biliary
Cotton- Stent
Huibregts Cotton-Huibregtse Biliary Stent w/
e Biliary Radiopaque Bands
Stent Cotton-
Cotton- Huibregt
Huibregts se Bilíary
e Biliary Stent
Stent Cotton-
Cotton- Huibregt
Huibregts se Biliary
e Biliary Stent
Stent Cotton-
Cotton- Huibregt
Huibregts se Biliary
e Biliary Stent
Stent Cotton- Huibregtse Biliary Stent
Cotton- w/ Radiopaque Bands Cotton-
Huibregts Huibregtse Biliary Stent
e Biliary Cotton-Huib regtse Biliary Stent
Stent w/ Radiopaque Bands Cqtton-
Cotton- Huibregtse Biliary Stent
Huibregts Cotton-Huibregtse Biliary Stent w/
e Biliary Radiopaque Bands
Stent
CFS 11464 3/19
AUT-
F0878-1
CLBS-10- 10 CLBS-10-11 CLBS-10- Cotton-Leung
12 CLBS-10-13 CLBS-10-14 CLBS- (Amsterdam) Biliary
10-15 CLBS-10-16 CLBS-10-17 Stent Set Cotton-
CLBS-10-18 CLBS-10-3 CLBS-10-4 Leung (Amsterdarn)
CLBS-10-5 CLBS-10-6 CLBS- 10-7 Biliary Stent Set
CLBS-10-8 CLBS-10-9 CLBS-11.5-1 Cotton-Leung
O CLBS-11.5-11 CLBS-11.5-12 CLBS- (Amsterdam) Biliary
11.5-13 CLBS-11.5-14 CLBS-11.5-15 Stent Set Cotton-
CLBS-11.5-16 CLBS-11.5-17 CLBS- Leung (Amsterdam)
11.5- 18 CLBS-11.5-3 CLBS-11.5- 5 Biliary Stent Set
CLBS-11.5-6 CLBS-11.5-7 CLBS- Cotton-Leung
11.5-8 CLBS-11.5-9 CLBS-5-12 (Amsterdam) Biliary
Stent Set Cotton-
CLBS-5-5 CLBS-5-7 CLBS-5-9
Leung (Amsterdam)
CLBS-7-11 CLBS-7-1O CLBS-7-12
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
CLBS-7-3 CLBS-7-4 CLBS-7-5 CLBS-
Stent Set Cotton-
7-6 CLBS-7-7 CLBS-7-8 CLBS-7-9
leung (Amsterdam)
CLBS-8.5-10
Biliary Stent Set
Cotton-Leung
{Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung {Amsterdam)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set
Cotton-Leung
{Amsterdam)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
leung (Amsterdam)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set
Cotton-leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set Leung (Amsterdam)
Cotton-Leung Biliary Stent Set
(Amsterdam) Biliary Cotton-Leung
Stent Set Cotton- (Amsterdam) Biliary
Leung (Amsterdam) Stent Set Cotton-
Stent Set Cotton- (Amsterdam ) Biliary
Biliary Stent Set Leung (Amster9am)
Biliary Stent Set Leung {Amsterdam)
Biliary Stent Set Leung {Amsterdam)
(Amster(.iam) Cotton-Leung
Bifiary Stent Set (Amsterdam) Biliary
Cotton-Leung Stent Set Cotton-
(Amsterdam) Biliary Leung (Amsterdam)
Stent Set Cotton- Biliary Stent Set
Leung (Amsterdam) Cotton-Leung
Biliary Stent Set {Amsterdam) Biliary
Cotton-Leung Stent Set Cotton-
(Amsterdam) Biliary Leung (Amsterdam)
Stent Set Cotton- Biliary Stent Set
CFS11464 4/19
AUT-F0878-1
CLBS-8.5-11 CLBS-8.5-12 CLBS-8.5- Cotton-Leung
13 CLBS-8.5-14 CLBS-8.5-15 CLBS- (Amsterdam) Biliary
8.5-16 CLBS-8.5-17 CLBS-8.5-18 Stent Set Cotton-
CLBS-8.5-3 CLBS-8.5-5 CLBS-8.5-6 Leung (Amsterdam)
CLBS-8.5-7 CLBS-8.5-8 CLBS-8.5-9 Biliary Stent Set
CLS0-5 -12 Cotton-Leung
CLS0- 5- 15 (Amsterdarn) Biliary
CLS0- 5-3 CLS0-5-5 CLS0-5-7 Stent Set Cotton-
CLS0- 5-9 CLS0-7-10 CLS0-7-11 Leung (Amsterdarn)
CLS0-7 -12 CLS0-7-13 CLS0-7-14 Biliary Stent Set
CLS0-7-15 CLS0-7-2 CLS0-7-3 Cotton-Leung
CLS0-7-4 CLS0-7 - 5 CLS0-7-6 (Arnsterdarn) Biliary
CLS0-7-7 CLS0-7-8 Stent Set Cotton-
CLS0-7 -9 CLS0-7-16 CLS0-7- 17 Leung (Amsterdarn)
CLS0-7-18 CLS0-7- 19 CLS0-7-20 Bíliary Stent Set
CLS0-7-21 CLS0-8.5-1O CLS0-8.5-11 Cotton-Leung
CLS0-8.5-12 CLS0-8.5-13 CLS0-8.5- (Arnsterdarn) Biliary
14 CLS0-8.5-15 CLS0-8.5-16 CLS0- Stent Set Cotton-
8.5- 17 CLS0-8.5- 18 Leung (Amsterdarn)
CLS0-8.5 -3 Biliary Stent Set
CLS0-8.5 -5 Cotton-Leung
CLS0-8.5-6 (Arnsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdarn)
Biliary Stent Set
Cotton-Leung
(Amsterdam) Biliary
Stent Set Cotton-
Leung (Amsterdam)
Biliary Stent Set
(Qtton-Leung
(Arnsterdam) Biliary
Stent Set Cotton-
leung (Amsterdam)
Biliary Stent Set
Cotton-Leung
Biliary Stent
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CFS11464 5/19
AUT-f0878- 1
CLS0-8.5-7 CLS0-8.5-8 CLS0-8.5-9 C
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Cetton Leung Biliary Stent system with Pre-loaded Cotton Leung
Oasis-ene actien stent introductien Biliary Stent
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OACL-8.5-9 OACL-8.5-5 OACL-8.5-15 Oasis-one action stent introduction
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OACL-7-5 OACL-7-7 OACL-7-9 OACL- Biliary Stent
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7-12 OACL-7-15 OACL-11.5-5 OACL- system with Pre-loaded Cotton Leung
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CLS0-11.5 - 14 CLS0-11.5-15 CLS0- Biliary Stent
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11.5 -3 CLS0-11.5-5 CLS0-11.5 -6 Biliary Stent
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CFS11464 7/19
AUT-F0878-1
OATS-11.5-15 OATS-11.5-5 OATS- Oasis-One Action
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CFS11464 B/19
AUT-F0878-1
TTS0-8.5-5 TTS0-8.5-6 TTS0-8.5-7 ST-2 Soehendra
TTS0-8.5-8 TTS0-8.5-9 ZEBD-7-10 Tannenbaum
ZEBD-7-7 ZEBD-10- 10 Biliary Stent ST-2
ZEBD- 10-3 ZEBD- 10-6 ZEBD-10-8 Soehendra
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ZEBD- 10-4 ZEBD-10-5 ZEBD- 10-7 Tannenbaum
ZEBD-5 -3 ZEBD-5-5 ZEBD-5-9 Biliary Stent ST-2
ZEBD-5-12 ZEBD-5-15 ZEBD-5-10 Soehendra
ZEBD-5-4 ZEBD-5-7 ZEBD-6-10 Tannenbaum
ZEBD-6- 12 ZEBD-6-4 ZEBD-7- 12 Biliary Stent ST-2
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AUT-F0878- 1
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CFS11464 10/19
AUT-
F0878-1
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GEPD-3-3 Geenen Pancreatic Stent Set
GEPD- 3-8 Geenen Pancreatic Stent Set
GEPD-8.5-3 Geenen Pancreatic Stent Set
GEPD-11.5 -12 Geenen Pancreatic Stent Set
GEPD-11.5 - 10 Geenen Pancreatic Stent Set
GEPD- 5- 12 Genen Pancreatic Stent Set
GEPD-5- 2 Geenen Pancreatic Stent Set
CFS11464 11/19
AUT-F0878- 1
GEPD-5 -7 Geenen Pancreatic Stent Set
GEPD-7- 14 Geenen Pancreatic Stent Set
GEPD-7 - 15 Geenen Pancreatic Stent Set
GEPD-8.5- 7 Geenen Pancreatic Stent Set
GPDS-5-3 Geenen Pancreatic Stent Set
GPS0-3-2 Geenen Pancreatic Stent Set
GPS0-3 -13 Geenen Pancreatic Stent Set
CFS11464 12/19
AUT-F0878- 1
GPS0-6-3 Géenen Pancreatic Stent Set
GPS0-8.5-3 Geenen Pancreatic Stent Set
GPS0-8.5-7 Genen Pancreatic Stent Set
CFS11464 13/19
AUT-F0878-1
GPS0-10-2 Geenen Pa ncreatic Stent Set
GPSOS-5-15 Geenen Pancreatic Stent Set
GPSOS-5-9 Geenen Pancreat ic Stent Set
GPSOS-7-9 Geenen Pa ncreatic Stecit Set
GPSOS-7-3 Geenen Pa ncreatic Stent Set
GPSOS-7-10 Geenen Pa ncreatic Stent Set
SPSOF-5-11 Zimmon Pancreatic Stent
SPSOF-6-8 Zim mon Pa ncreatic Stent
SPSOF-7-7 Zim mon Pancreatic Stent
SPSOF-7-5 Zimmon Pancreat ic Stent
SPSOF-7-2.5 Zimmon Pancreatic Stent
SPSOF-7-6 Zimmon Pancreati c Stent
SPSOF-4-18 Zim mon Pancreati c Stent
SPSOF-4-4 Zim mon Pancreati c Stent
SPSOF-5-1 O Zim mon Pancreatic Stent
SPSOF-5-4 Zimmon Pa ncreatic Stent
CFS11464 14/19
AUT-F0678 -1
SPSOF-6-6 Zirnmon Pancreatic Stent
SPSOF- 10- 12 Zii:nmon Pancreatic Stent
SPSOF-10-1 O Zimmon Pancreatic Stent
SPSOF-10 -4 Zimmon Pancreatic Stent
SPSOF-8.5-12 ·Zimmon Pancreatic Stent
SPSOF-8.5-1O Zimmon Pancreatic Stent
SPSOF-8.5-7 Zimmon Pancreatic Stent
SPSOS-5-5 Zimmon Pancreatic Stent
SPSOS-5-7 Zirnmon Pancreatic Stent
SPSOS-3-18-N Zimmon Pancreatic Stent
SPSOS-3 - 10-N Zimmon Pancreatic Stent
ZEPDF-5-10 Zimmon Pancreatic Stent Set
ZEP. DF-5-5 Zimmon Pancreatic Stent Set
ZEPDF-7 -5 Zimmon Pancreatic Stent Set
ZEPDF-7-8 Zir.nmon Pancreatic Stent Set
CFS11464 15/19
AUT-F0878-1
ZEPDF-7-9 ZEPDS-5-2 ZEPDS-5- Zimm
10 ZEPDS-5-12 ZEPDS-5-8 on
ZEPDS-5-4 ZEPDS-5-6 ZEPDS-7 -4 Pancr
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CFS11464 16/19
AUT- F0878-1
DT-6 Duette ® Multi Band
DT-6-XL DT-6-5F Mucosectomy
CDSG-14-175 CDSM-7 CDSM-8.5 Device Duette®
CDSM-10 DCB-S-50 DCB-D-50 DCB- Multi Band
SV-50 DCB-DV-50 Mucosectomy
EV0-20-25-8-E Device Duette®
Multi Band
Mucosectomy
Device Colon
Decompression Set
Marcen
Colon
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DISPOSABLE
ENDOSCOPIC CLEANING
BRUSH DISPOSABLE
ENDOSCOPIC CLEANING
BRUSH DISPOSABLE
ENDOSCOPIC CLEANING
BRUSH SET
DISPOSABLE
ENDOSCOPIC CLEANING
BRUSH SET
Evolution™ Esophageal Stent System-
Partially Covered
EV0-20-25-1O-E Evolution1 Esophageal Stent System-Part
ially Covered
EV0-20-25-12.5-E EV0-20-25-15-E Evolution™ Esophageal Stent
NPDS-5 System-Partially Covered
NPDS-7 Evolutionr"' Esophageal Stent
ECH0-20-CPN ECH0-19 ECH0-1-22 System-Partially Covered Nasal
JPWS-10-10 Pancreatic Drainage Set
Nasal Pancreatic Drainage Set
EchoTip® Ultra Celiac
Plexus Neurolysis Needle
EchoTip ® Ultra
EchoTip® Ultra
Johlin™ Pancreatic Wedge Stent and
lntroducer "
JPWS-10-12 Johlin1 Pancreatic Wedge Stent and '
lntroducer
JPWS- 10-14 JPWS-10-16 JPWS-10- Johlin™ Pancreatic
18 JPWS-10 -20 JPWS-10-22 Wedge Stent and
lntroducer Johlin™
Pancreatic Wedge
Stent and lntroducer
Johlin™ Pancreatic
Wedge Stent and
lntroducer Johlin™
Pancreatic Wedge
Stent ano lntroducer Wedge Stent and
JohlinrM Pancreatic lntroducer
JPWS-10-8 Johlin1 Pancreatic Wedge Stent and
lntroducer
"
'
JPWS-8.5-1O Johlin™ Pancreatic Wedge Stent and
lntroducer
JPWS-8.5-12 Johlin1 Pancreatic Wedge Stent and
lntroducer
JPWS-8.5-14 Johlin™ Pancreatic Wedge Stent
JPWS-8.5-16 JPWS-8.5-18 and lntroducer Johlin1 Pancreatic
JPWS-8.5-20 JPWS-8.5-22 Wedge Stent and lntroducer
JPWS-8.5-8 Johlin™ Pancreatic Wedge Stent
EV0-22-27-12-D EV0-22-27-6-D and lntroducer Johlin™
EV0-22-27-9-D EV0-25-30- 10-C Pancreatic Wedge Stent and
EV0-25-30-6-C lntroducer Johlinr"' Pancreatic
EV0-25-30-8-C ECH0-25 Wedge Stent and lntroducer
ECHO-HD-19-A SPSOF-4-12 Johlin™ Pancreatic Wedge Stent
SPSOF-4-15 and lntroducer Evolution ®
ECHO-HD-22-EBUS-O Duodenal Stent System -
Uncovered Evolution® Duodenal
ECHO-HD-22-EBUS-P Stent System - Uncovered
Evolution ® Duodenal Stent
EVO-FC-18-23-8-E EVO-FC-18-23-10-E System - Uncovered Evolution®
Colonic Stent System -
Uncovered Evolution® Colonic
Stent System - Uncovered
Evolution ® Colonic Stent System
- Uncovered EchoTip® Ultra
EchoTip ® Ultra High Definition Ultrasound
Acces s Needle Zimmon Pancreatic Stent
Zimmon Pancreatic Stent
EchoTip ® Ultra Endobronchial High
Definition Ultrasound Needle
EchoTip® Ultra Endobronchial High
Definition Ultrasound Needle
Evolution® Esophageal Stent
System-Fully Covered Evolution®
Esophageal Stent System-Fully
Covered
CFS11464 17/ 19
AUT-F0878 1
EVO-FC-18-23-12-E EVO- FC-20-25-8- Evolution® Esophageal Stent
E EVO-FC-20-25 -10-E EVO-FC-20-25- System-Ful ly Covered
12-E ECHO-HD- 19-C ECHO-HD-22-C Evolution® Esophageal Stent
SPSOF-6-12 System-Fully Covered Evolution®
SPSOF-6-15 ECHO-HD-25-C EV0- Esophageal Stent System-Fully
8-9-4-B Covered Evolution® Esophageal
EV0-8-9-6-B Stent System-Fully Covered
EV0-8-9-8- B EchoTip® ProCorerM H.D
EV0-8-9-10-B Ultrasound Biopsy Needle
EV0-10-11-4-B EchoTip® ProCore™ HD
Ultrasound Biopsy Needle
EV0-10-11-6-B
EV0-10-11-8-B EV0-10-11-10-B
EVO-FC-R- 18-23-8-E
EchoTip ® ProCore™ HD
EVO-FC-R-18-23-10-E
Ultrasound Biopsy Needle
EVO-FC-R-18-23-12-E
Evolution ® Biliary Stent System-
EVO-FC-R-20-25-8 -E
Uncovered Evolution ® Biliary
EVO-FC-R-20-25-1O-E
Stent System- Uncovered
EVO-FC-R-20-25-12 - E
EVO-PC-8-9-6-B
EVO-PC-8-9-8-B
Stet System- Uncovered
EVO-PC-10-11-4-B
EVO-PC-10-11-6-B
Uncovered
EVO- PC-10-11-8-B
EVO-FC-8-9 -6-B
EVO-FC-8-9-8-B
Stent System- Uncovered
EVO-FC-10-11-4- B
EVO-FC-10-11-6 -B
Uncovered Evolution®
EVO-FC-10- 11-8-B EUSN-19-QC
Esophageal Stent System- Fully
Covered Evolution® Esophageal
ECHO-HD-3-20-C ECHO-HD-25-EBUS-O
Stent System- Fully Covered
Evolution® Esophageal Stent
ECHO-HD-25-EBUS- P
System- Fully Covered Evolution®
Esophageal Stent System- Fully
ECHO-HD -22-EBUS-0-C ECHO-HD-22-
Covered Evolution ® Esophagea·I
EBUS-P-C ECHO-HD-25-EBUS-O-C ECHO-
Evolution ® Esophageal Stent
System- Fully Covered Evolution
HD-25-EBUS-P-C
® Biliary Stent System- Partially
Covered Evolution ® Biliary Stent
System- Partially Covered
CLSO-SF-7- 5 CLSO-SF-7-7
Partially Covered Evolution ®
Biliary Stent System- Partially
Covered Evolution ® Biliary Stent
System- Partially Covered
Fully Covered Evolution ® Biliary
Stef'lt System- Fully Covered
Fully Covered Evolution ® Biliary
Fully Covered QUICK-CORE ®
ENDOSCOPIC ULTRASOUND
BIOPSY NEEDLE
ECHOTIP PROCORE ® HD ULTRASOUND
BIOPSY
NEEDLE Echotip Procore® End0bronchial HD
EchoTip® Ultra Endobronchial High Ultrasound Biopsy Needle for Olympus
Definition Ultrasound Needle Scopes
EchoTip® Ultra Endobronchial High Echotip Procore® Endobronchial HD
Definition Ultrasound
Ultrasound Biopsy Needle for Pentax
Needle
Scopes
Echotip Procore ® Endobronch ial HD
Ultrasound Biopsy Needle for Olympus
Cotton-Leung ®
Scopes Sof-Flex ® Biliary
Echotip Procore® Endobronchial HD
Ultrasound Biopsy Stent Cotton-Leung
Needle for Pentax Scopes ® Sof- Flex® Bíliary
Stent
CFS11464 18/19
AUT-F0878-1
CLSO-SF-7- 12 CLSO-SF-7-9 CLSO- Cotton-Leung ® Sof-
SF-7-15 CLSO-SF-10-5 CLSO-SF- 10- Flex® Biliary Stent
7 CLSO-SF-10-9 CLSO-SF-10-12 Cotton-Leung ® Sof-
CLSO-SF-10 - 15 ZSS-10 -3- RB Flex ® Biliary Stent
ZEBD-6-7 Cotton-Leung ® Sof-
GPSO-SF-5-5 GPSO-SF-5-3 GPSO- Flex ® Biliary Stent
SF-5-7 GPSO-SF-5-9 GPSO-SF-5-12 Cotton-Leung® Sof-
GPSOS-SF-5-3 GPSOS-SF-5-5 Flex ® Biliary Stent
GPSOS-SF-5- 7 GPSOS-SF-5-9 Cotton-Leung® Sof-
GPSOS-SF-5-12 ZD0-22-30 Flex ® Biliary Stent
Cotton-Leung ® Sof-
Flex ® Biliary Stent
Flex® Biliary Stent
Flex ® Biliary Stent
So_lus ® Double
Pigtail Stent with
lntroducer Zimmon ®
Biliary Stent Set
Geenen® Sof-
Flex ®
Pancreatic
Stent
Geenen® Sof-
Flex ®
Pancreatic
Stent
Geenen® Sof-
Flex ®
Pancreatic
Stent Geenen
® Sof-Flex®
Pancreatic
Stent Geenen
® Sof-Flex ®
Pancreatic
Stent Geenen
® Sof-Flex ®
Pancreatic
Stent
Geenen® Sof-
Flex ®
Pancreatic
Stent
Geenen® Sof-
Flex ®
Pancreatic
Stent
Geenen® Sof-
Flex ®
Pancreatic
Stent Geenen
® Sof-Flex®
Pancreatic
Stent Zenker
Overtube
19/19
LETTER OF MANUFACTURER
April 30, 2021
To: Health Authorities in Peru
We: Cook Ireland Limited

O´Halloran Road
National Technology Park
Limerick
Ireland
Re: Letter of Manufacturer
Declare that the following products listed in the Certificate of Free Sale (CFS11464) may be legally
exported and imported from Ireland.
Please see below for the following details:
GMDN 1 /NBOG2 Codes
Product Nomenclature System Code Term

Family
Evolution® GMDN - Initial code 36227 Oesophageal stent
Esophageal GMDN Code - 43531 Hybrid/coated oesophageal stent
Stent Previous
System GMDN Code - Current 61751 Polymer-metal oesophageal
stent, sterile
NBOG MD0101 Non-active devices for
anaesthesia, emergency and
intensive care
Evolution® GMDN - Initial code 37847 Bare-metal colonic stent
Colonic GMDN Code - Current 37847 Bare-metal colonic stent
Stent NBOG MD0101 Non-active devices for
System anaesthesia, emergency and
intensive care
1- Global Medical Devices Nomenclature System 2– Notified Body Operation Group
This product has a GMDN Code: 36227 and term: Oesophageal stent.
This product has a GMDN Code: 37847 and term: Bare-metal colonic stent.
The Real Part Number (RPN) indicated as REF on the label is the catalogue number that has been
assigned to the device. The RPN typically contains the prefix of the product family and the essential
dimensional information e.g. length, diameter. The Global Product Number (GPN) is a unique 5-digit
number which can also be used when placing an order. Every catalogue item has both a RPN and a
GPN. Both numbers are listed on the product label as REF, however only the RPN appears on the CFS.
Product Name Global Product

Real Part Number
Number
EVO-25-30-6-C Evolution® Colonic Stent System- Uncovered G48029
EVO-FC-18-23-8-E Evolution® Esophageal Stent System- Fully Covered G51181
We will be grateful for your consideration of this information during the process of evaluation.
Talita Feitosa da Silva

Regulatory Affairs Associate
CARTA DEL FABRICANTE
30 de abril del 2021

Para: Las autoridades sanitarias en Perú
Nosotros: Cook Ireland Limited
O´Halloran Road National Technology Park Limerick
Ireland
Re: Carta del fabricante

Declaro que los siguientes productos enumerados en el Certificado de Libre Venta (CFS11464)
pueden ser exportados e importados legalmente desde Irlanda.
Por favor, vea a continuación los siguientes detalles:
Códigos GMDN1 /NBOG2
Familia de Sistema de Código Término

productos nomenclatura
Evolution® GMDN - Código inicial 36227 Stent esofágico

Esophageal
Stent System Código GMDN- 43531 Stent esofágico
Anterior híbrido/recubierto
Código GMDN - Actual 61751 Stent esofágico polimérico-

metálico estéril
NBOG MD0101 Dispositivos no activos para

anestesia, emergencia y
cuidados intensivos
Evolution® GMDN - Código inicial 37847 Stent colónico sin recubrimiento

Colonic Stent
System Código GMDN - Actual 37847 Stent colónico sin recubrimiento
NBOG MD0101 Dispositivos no activos para

anestesia, emergencia y
cuidados intensivos
1- Sistema Global de Nomenclatura de Dispositivos Médicos
2- Grupo de Operación de Organismos Notificados
Este producto tiene un código GMDN 36227 y término: Stent esofágico.

Este producto tiene un código GMDN 37847 y el término: Stent colónico de metal sin
recubrimiento.
El número de pieza real (NPR) indicado como REF en la etiqueta es el número de catálogo
que se ha asignado al dispositivo. El RPN suele contener el prefijo de la familia de
productos y la información dimensional esencial, por ejemplo, la longitud y el diámetro.
El número global de producto (NGP) es un número único de 5 dígitos que también puede
utilizarse al hacer un pedido. Cada artículo del catálogo tiene un NPR y un NGP. Ambos
números aparecen en la etiqueta del producto como REF, pero sólo el NPR aparece en el
Certificado de libre venta.
Número de Pieza Nombre del producto Número Global del

Real Producto
EVO-25-30-6-C Evolution® Colonic Stent G48029
System- Uncovered
System- Uncovered
System- Uncovered
EVO-FC-18-23-8-E Evolution® Esophageal Stent G51181
System- Fully Covered
Le agradeceremos que tenga en cuenta esta información durante el proceso de evaluación
Talita Feitosa da Silva

Responsable de Asuntos Regulatorios
Certificate
No. Q5 033038 0038 Rev. 01
Holder of Certificate: Cook Ireland Limited

O'Halloran Road
Limerick
IRELAND
Facility(ies): Cook Ireland Limited

O'Halloran Road, National Technology Park, Limerick, IRELAND
See Scope of Certificate
Certification Mark:
Design, Development, Manufacture and Distribution of Disposable Devices

Scope of Certificate: for Use in Pulmonary, Urological, Gastroenterological and
Obstetric/Gynaecological Procedures - Including Catheters, Introducers,
Wires, Drainage Sets, Electrosurgical and Non-Active Instruments, Stents,
Stent Grafts, Needles, Cannulae, Self Expandable Vascular Stents and
Delivery Systems, Drug Eluting Peripheral Stents with Delivery Systems and
Vascular Needles and Connecting Tubes.
Applied Standard(s): EN ISO 13485:2016

Medical devices - Quality management systems -
Requirements for regulatory purposes
(ISO 13485:2016)
DIN EN ISO 13485:2016
The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system, which meets the
requirements of the listed standard(s). All applicable requirements of the testing and certification
regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see:
www.tuvsud.com/ps-cert?q=cert:Q5 033038 0038 Rev. 01
Report No.: 75950473
Valid from: 2021-12-22

Valid until: 2024-06-21
Date, 2021-12-17 Christoph Dicks

Head of Certification/Notified Body
Page 1 of 1
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Certificado
N.° Q5 033038 0038 Rev. 01
Titular del Certificado: Cook Ireland Limited

O'Halloran Road
Limerick
IRELAND
Instalación(es): Cook Ireland Limited

O'Halloran Road, National Technology Park, Limerick, IRELAND
Ver Alcance del Certificado
Marca de certificación:
Alcance del Certificado: Diseño, Desarrollo, Fabricación y Distribución de Dispositivos de un

solo Uso en Cirugía Pulmonar, Urológica, Gastroenterológica y
Procedimientos obstétricos/ginecológicos: incluidos catéteres,
introductores, cables, equipos de drenaje, instrumentos
electroquirúrgicos y no activos, stents, injertos de stent, agujas,
cánulas, stents vasculares autoexpansibles y sistemas de de
implantación, stents periféricos liberadores de fármacos con
sistemas de implantación y Agujas vasculares y tubos de conexión.
Norma EN ISO 13485:2016

Dispositivos médicos - Sistemas de gestión
Norma(s) aplicada(s): de la calidad - Requisitos con fines
regulatorios
(ISO 13485:2016)
DIN EN ISO 13485:2016
El organismo notificado de TÜV SÜD Product Service GmbH certifica que la empresa mencionada
anteriormente ha establecido y mantiene un sistema de gestión de calidad que cumple con los requisitos
de las normas enumeradas. Se deben cumplir todos los requisitos aplicables de la regulación de pruebas
y certificación de TÜV SÜD Group. Para obtener más información y la validez del certificado, consulte:
www.tuvsud.com/ps-cert?q=cert:Q5 033038 0038 Rev. 01
Reporte no.: 75950473
Válida desde: 2021-12-22

Válido hasta: 2024-06-21
Christoph Dicks
Fecha, 2021-12-17
Jefe de Certificación/Organismo Notificado
Página 1 de 1
TÜV SÜD Product Service GmbH • Organismo Notificado • Ridlerstraße 65 • 80339 Múnich • Alemania
INFORME TÉCNICO
EVOLUTION® COLONIC STENT SYSTEM-UNCOVERED
1. DESCRIPCIÓN DEL DISPOSITIVO MÉDICO

El producto Evolution® Colonic Stent System, consta de los dos componentes:
- Stent metálico autoexpandible
- Sistema de implantación del stent (formado por el mango y el Introductor)
1.1 Stent metálico autoexpandible.

Este stent flexible y auto expandible está construido con un único alambre de nitinol tejido. El
stent se acorta debido a su diseño. Su longitud total se indica mediante marcadores radiopacos
en el catéter interior, que indican la longitud real del stent con el diámetro nominal de la misma.
Ambos extremos están expandidos: el aumento del diámetro del stent en los extremos de la
misma tiene por objeto proporcionar resistencia a la migración. Para facilitar la visibilidad bajo
fluoroscopia, hay cuatro bandas marcadoras de tantalio en cada extremo del stent. Los extremos
proximal y distal del stent están diseñados con numerosas "coronas" redondeadas para reducir
potencialmente el traumatismo tisular.
Imagen referencial.
1.2 Sistema de implantación del stent (formado por el mango y el Introductor)
El stent está montado en un catéter interior, que acepta una guía de alambre de 0,035
pulgadas, y está limitado por un catéter exterior. Un Mango de implantación con
empuñadura de pistola permite la inserción o recaptura del stent.
El sistema de implantación consta de (a) dos catéteres que funcionan de forma coaxial
con la endoprótesis precargada colocada entre el catéter interior y el exterior, y (b) un

Mango para colocar la endoprótesis. La endoprótesis se libera retrayendo el catéter
exterior para exponer la endoprótesis, y entonces la endoprótesis se auto expande y se
ajusta a la anatomía del duodeno o del colon. Consulte la Imagen A para el despliegue
del stent, la Imagen B para una visión general y la Imagen C para el mango.
Este sistema de implantación se suministra estéril y está indicado para un solo uso.
Imagen A (despliegue del Stent)
Imagen B (visión general)

Imagen C (mango)
Un Mango de despliegue con una sola mano controla el movimiento del catéter interior con
respecto al catéter exterior. El mango fue diseñado para optimizar el control y la eficiencia del
médico durante el despliegue del stent. El sistema también ofrece al usuario la posibilidad de
volver a capturar el stent si es necesario reposicionarlo durante el proceso. El botón de dirección
situado en el lateral del mango se desplaza hacia el lado opuesto, invirtiendo la dirección en
que se mueve el catéter exterior, lo que permite volver a capturar el stent. Una vez que el stent
está completamente recogido dentro del catéter exterior, puede volver a desplegarse. Un
marcador de "punto de no retorno" en el mango indica el punto después del cual no es posible
recapturar el stent desplegado.
MODELOS Evolution® Colonic Stent System
Número Nombre Diámetro del Longitud del Longitud Diámetro Diámetro

de del sistema de sistema de del Stent del cuerpo del borde
producto producto implantación implantación (mm) de Stent del stent
(cm) (mm) (mm)
EVO-25- Evolution 230 cm± 3cm 60 25 30
30-6-C Colonic
EVO-25- Stent 10 Fr 230 cm± 3cm 80 25 30
30-8-C System
EVO-25- Uncovered 230 cm± 3cm 100 25 30
30-10-C
Tabla 1
Los productos Evolution® Colonic Stent System no contienen:

- Ningún medicamento.
- Derivados de sangre humana.
- Tejidos de origen humano o animal.
Los productos Evolution® Colonic Stent System.

- Se suministran estériles y para un solo uso.
- No están destinados a ser esterilizados por el usuario final
ACCESORIOS
Guía de alambre de 0,035 pulgadas (consulte las Instrucciones de Uso correspondientes para
más detalles).
Nota: Los accesorios no vienen con el producto.
MATERIALES
En la siguiente tabla se detalla un listado de los materiales utilizados por el fabricante en los
productos Evolution® Colonic Stent System.
Tenga en cuenta que algunos componentes tienen diferentes números RMN dependiendo del
tamaño del stent.
RMN Descripción Material ¿en contacto Número de

con el especificación (por
paciente? ejemplo, número de
DWG/CHT/ RMS)
Stent
12-040 Stent colónico Ver componentes Sí DWG0289
ensamblado del stent
Componentes del stent
25-402 Alambre de Nitinol Sí RMS0028
Nitinol
10-145 Bandas Tantalio Sí RMS0041
marcadoras
N/A Silicona Silicona Nusil Sí DWG0289
grado MED-4755
Tabla 2 Evolution® Colonic: Materiales de los Stent
RMN Descripción Material ¿en Número de

contacto especificación
con el (por ejemplo,
paciente? número de
DWG/CHT/
RMS)
28-118 Cierre de Polycarbonato grado No DWG0325
seguridad Lexan 241R
Stent de implantación N° IRS0055/ IRS0056/ IRS0057
25-066 Adhesivo Adhesivo Sí IQC0028
Loctite 4061
(15544)
10-146 Cánula de acero Acero inoxidable 304 No RMS0025
inoxidable
K22R,
L=75mm+/-
28-114 Enchufe FLLA Lupilon GSH2010RS No DWG0319
(10% policarbonato
relleno de vidrio)
28-108 Cargador Policarbonato grado 24 No DWG0313
IR
28-141 Alambre de Alambre de nitinol Sí RMS0040
nitinol de 0,12
pulgadas de
diámetro
mecánico
21-078 Cánula TTS, Acero inoxidable ANSI No DWG0332
abocinada: OD 304
0.091-0.093, ID
0
21-067 Adaptador - Policarbonato (80130) Indirecto* WCM-DWG-
luerlock hembra. 15527
0.070 (15527)
15-279 Tubo: Tantalio Tantalio Indirecto WCM-DWG-
0.097 x .103 mm 19547
(19547)
16-023 Tubo PTFE OD PTFE Sí RMS0024
0.095"+0.001"-
0.002"
16-025 Gancho de Acero inoxidable ASTM Sí DWG0337

recuperación 302/ 304
Gastro SEMS
TTS
28-113 Boquilla-34 Policarbonato GE grado No DWG0318
plástico Lexan 24 IR
28-110 Tapa de Lupilon GSH2010R2 No DWG0315
cargador-34 (10% policarbonato
relleno de vidrio)
28-155 Banda de Policloropeno/cordón de No IQC0477
transmisión vidrio/poliamida RMS0093
Optibelt 316XL
025 77ST

Loctite 4013
20gramos
(20268/260)
28-095 Cánula de Pebax 3533 con 40% de Sí DWG0302
introducción bario
TTS, Pebax
3533 con 40%
de bario
90-249 Sin etiqueta de FASSON PE 85 TOP No RMS0046
90-250 devolución blanco/S692N/BG40
90-251 blanco
28-144 Fijación de la Aluminio No DWG0417
polea de
accionamiento
RMN
30-330 Muelle de Acero inoxidable con No DWG0346
compresión revestimiento de PTFE
SEMS
28-107 Rodillo CAM Delrin 500P NC010 de No DWG0312
grado acetal-dúplex
28-123 Perno de la Acero inoxidable 304 No DWG0328
rueda loca
28-105 Poleas de la Delrin 500P NC010 de No DWG0311
banda grado acetal-dúplex
28-146 CarcMango PC/ABS (mezcla de No DWG0455
exterior TTS policarbonato/acrilonitrilo
izquierda butadieno estireno) grado
de plásticos GE C2950
28-147 CarcMango PC/ABS (mezcla de No DWG0456
exterior TTS policarbonato/acrilonitrilo
derecha butadieno estireno) grado
de plásticos GE C2950
Ensamblaje de peek y de polimida IRS0333 / IRS0334 / IRS0335
10-141 Tubo de Polimida trenzada con Sí RMS0037
polimida acero inoxidable 304V @
trenzada 375- 80 PIC
III.5BRD
15266 Banda Tantalio Sí RMS0023
marcadora
radiopaca de
tantalio L= 3mm
18-123 Tubo: 7.1 FR Interior: Nylon con Sí DWG0485
Nylon RO bismuto y colorante,
coextruido, exterior: Nylon con
Panton colorante añadido
16-024 Tubo: OD PEEK PEEK templado Sí RMS0005
0.076" +/- 002"
Loctite 4061
(15544)
Tubo de nylon lateral (EVO) - IRS0050
18-107 Tubo: 7FR Nailon - 12 natural No DWG1169
Nylon-12,
Natural 240 cm
(18527)
Ensamble de revestimiento SEMS TTS-lRS0070/0073/0074
18-359 Cubierta exterior Revestimiento de PTFE, Sí DWG1879
o 18- Gastro SEMS, superficie exterior de
360 o 10FR, Nylon (la sección distal
18-361 LD=130mm transparente es un
o copolímero de
Pebax/Nylon) Trenzado:
Cubierta exterior Acero inoxidable 304V
Gastro SEMS, Bobina: Acero inoxidable
10 FR, 302/304
LD=175mm
o
Cubierta exterior
de Gastro
SEMS, 10 FR,
LD=230mm
Cubierta exterior
Gastro SEMS, 1
0FR,
LD=175mm
N/A Permabond 820 Adhesivo No DWG1879
Dymax UV
Set de engranajes SEMS TTS-IRS0051
28-098 Engranaje 1 Acetal (DuPont Grade No DWG0304
(engranaje de Delrin 500P NC010)
transmisión
izquierdo)
(Engranaje de la Delrin 500P NC010)
polea izquierda)
(engranaje de Delrin 500P NC010)
transmisión
derecho)
polea derecha)
polea derecha)
(Engranaje de Delrin 500P NC010)
accionamiento
del gatillo)
28-104 Polea motriz Acetal (DuPont Grade No DWG0310
Delrin 500P NC010)
28-111 Engranaje de la Policarbonato de grado No DWG0316
cremallera Lexan 24IR
(engranaje de la
cremallera del
mango SEMS)
28-112 Interruptor de Policarbonato de grado No DWG0317

dirección Lexan 24IR
28-117 Muelle-poste Policarbonato de grado No DWG0322
Lexan 24IR
28-124 Eje de la polea Acero inoxidable 304 No RMS0252
28-122 Eje de Acero inoxidable 316 No RMS0252
accionamiento
Tabla 3 Materiales del sistema de stent duodenal/colónico Evolution®
Todos los materiales enumerados en la tabla 3 son comunes a todas las gamas de productos
del sistema de stent duodenal/colónico Evolution®, excepto cuando se especifica en la tabla 5
Consulte la Tabla 4 para obtener orientación sobre los IRS.
EVO-25-30-10-C
EVO-25-30-6-C
EVO-25-30-8-C
Evolution® Colonic Stent System.

IRS0050 X X X
IRS0051 X X X
IRS0055 X
IRS0056 X
IRS0057 X
IRS0070 X
IRS0073 X
IRS0074 X
IRS0333 X
IRS0334 X
IRS0335 X
Tabla 4 IRS y números de pieza (x indica el IRS aplicable a ese número de pieza)
EVO-25-30-10-C
EVO-25-30-6-C
EVO-25-30-8-C
Stent de Implantación N°
90-249 X
90-250 X
90-251 X
Ensamblaje de revestimiento SEMS TTS
18-359 X
18-360 X
18-361 X
Tabla 5 Materiales utilizados en el Stent de implantación y en el ensamblaje del revestimiento SEMS
TTS (excluyendo los materiales comunes) (la x indica dónde se suministra)
Evolution® Colonic Stent System.

FQCO 172 FQC Instrucción para el dispositivo terminado de stent duodenal/colónico
FQCO 171 FQC Instrucción para introductor de stent duodenal/colónico y mango IRS
FQCOl 75 Instrucción FQC para IRS0050
1. INDICACIONES DE USO
● No utilice este dispositivo para otro propósito que no sea el especificado en las
indicaciones.
● No utilice el dispositivo si el envase está abierto o dañado cuando lo reciba.
Inspeccione visualmente el dispositivo, prestando especial atención a la
presencia de plicaturas, dobleces o roturas.
● No lo utilice si detecta alguna anomalía que pudiese impedir su correcto
● funcionamiento. Notifíquelo a Cook para obtener una autorización de
devolución.
● Este dispositivo sólo pueden utilizarlo profesionales sanitarios cualificados.
.
2. CONTRAINDICACIONES
Las específicas de la endoscopia gastrointestinal y de los procedimientos que se realicen
junto con la colocación de stents. Las contraindicaciones también incluyen, entre otras:
isquemia enteral, sospecha o amenaza de perforación, absceso o perforación
intraabdominales, incapacidad para hacer pMangor la guía o el stent a través de la zona
obstruida, pacientes en los que estén contraindicados los procedimientos endoscópicos,
coagulopatía importante y enfermedad benigna.
3. COMPLICACIONES
 Las asociadas a la endoscopia gastrointestinal incluyen, entre otras:
perforación, hemorragia, fiebre, infección, reacción alérgica a la medicación,
hipotensión, depresión o parada respiratorias, y arritmia o parada cardíacas.
 Las complicaciones también incluyen, entre otras: perforación intestinal,

dolor, expansión inadecuada, colocación incorrecta o migración del stent,
crecimiento hacia el interior o hiperplasia del tumor, oclusión del stent,
ulceraciones, necrosis por presión, erosión de la mucosa luminal, septicemia,
sensación de presencia de cuerpos extraños, impactación intestinal, diarrea,
estreñimiento, peritonitis, síntomas de tenesmo o necesidad imperiosa de
orinar/incontinencia, y muerte (aparte de las debidas a la evolución normal de
la enfermedad).
4. PRECAUCIONES
● La etiqueta del envase especifica el tamaño mínimo del canal requerido para
este dispositivo.
● Antes de utilizar este dispositivo, debe realizarse una evaluación diagnóstica
completa para determinar el tamaño adecuado del stent.
● Si la guía o el stent no pueden avanzar a través de la zona obstruida, no intente
colocar el stent.
● El stent debe colocarse mediante endoscopia con guía fluoroscópica.
● El stent sólo debe colocarse utilizando el sistema de implantación Cook,
suministrado con cada stent.
● Este dispositivo está indicado únicamente para el tratamiento paliativo. Los
métodos de tratamiento alternativos deberán investigarse antes de la colocación
del stent.
● Tras la colocación del stent, no deben utilizarse otros métodos de tratamiento,
como la quimioterapia y la radioterapia, ya que podrían aumentar el riesgo de
migración del stent por encogimiento tumoral, erosión del stent o hemorragia
mucosa.
● No se ha demostrado que este stent mantenga la permeabilidad a largo plazo. Se
recomienda realizar evaluaciones periódicas.
5. RESTRICCIONES DE USO
● No utilice este dispositivo para otro propósito que no sea el especificado en las
indicaciones.
● No utilice el dispositivo si el envase está abierto o dañado cuando lo reciba.
Inspeccione visualmente el dispositivo, prestando especial atención a la
presencia de plicaturas, dobleces o roturas.
● No lo utilice si detecta alguna anomalía que pudiese impedir su correcto
funcionamiento. Notifíquese a Cook para obtener una autorización de
devolución.
● Este dispositivo sólo pueden utilizarlo profesionales sanitarios cualificados.
6. ADVERTENCIAS
● El stent no está concebido para extraerse ni para cambiarse de posición una vez
colocado, sino para dejarse colocado permanentemente en el cuerpo. Si se
intenta extraer el stent o cambiarlo de posición una vez colocado, pueden
producirse daños en el tejido o la mucosa adyacentes. El stent no puede
recuperarse después de que se haya pMangodo el umbral del despliegue. Las
marcas correspondientes del catéter exterior y el mango de implantación indican
cuándo se ha pMangodo el umbral.
● Este stent contiene níquel, que puede provocar reacciones alérgicas en
individuos alérgicos al níquel.
● Para reducir al mínimo el dolor y el tenesmo, el extremo del stent más cercano
al conducto anal o al ano debe colocarse 2 cm por encima del conducto anal o a
6 cm del ano.
● El dispositivo debe utilizarse con cautela y solo después de una atenta
consideración en pacientes con:
-Pacientes con colitis o proctitis por radiación.
-Pacientes con tiempos de hemorragia elevados o coagulopatías.
7. FORMA DE PRESENTACIÓN
El producto se coloca dentro de una bandeja con tapa (bandeja y tapa de
Polietilenglicol tereftalato), con un tubo protector del stent, de Polipropileno.
Seguidamente se coloca en dos bolsas de Polietileno tereftalato/Polietileno, Mylar y
Tyvek.
Código Componente RM Número Material

(CPN)
EVO-XX- Tubo protector del 18-124 PPNT (Polipropileno)
XX-(X)X-C stent
Bandeja 20-116 PETG (Polietilenglicol
tereftalato)
Tapa de bandeja 20-120 PETG (Polietilenglicol
tereftalato)
Bolsa interior 26-005 Película PET/PE (Polietileno
tereftalato/Polietileno): 35890-G
o grado equivalente 12/50,
Mylar, Tyvek 1073B CR27
Bolsa exterior 26-006 Película PET/PE (Polietileno
tereftalato/Polietileno): 35890-G
o grado equivalente 12/50,
8. VIDA ÚTIL
24 meses
9. CONDICIONES DE ALMACENAMIENTO
Almacenar en un lugar seco y protegido de temperaturas extremas
10. FLUJOGRAMA DE FABRICACIÓN

Ver documento 4.a Flujograma
11. DESCRIPCIÓN DE LA EFICACIA Y SEGURIDAD (CONDICIONES

ESENCIALES DE SEGURIDAD Y EFICACIA)
Ver documento 4.b. Requerimientos Esenciales de Seg y Eficacia (CheckList)
APENDICE E: DIAGRAMA DE FLUJO DE PROCESO DE MANUFACTURA DE COOK IRLANDA
ITF 049- SET DE INSTRUMENTOS DE METAL
DIAGRAMA DE FLUJO 1: PROCESO DE MANUFACTURA COOK IRLANDA
CUARTO DE STOCK/ FLUJO DE PROCESO DE PRODUCTO TERMINADO

FLUJO DEL PROCESO DE ENSAMBLAJE SECUNDARIO
Ej. Dilatadores/ Solamente stent, FLLAs
IMPRIMIR PRODUCTO
TERMINADO W/O y ROTULO
CUARTO DE IMPRESION DEL EMBARQUE
STOCK O ENSAMBLAJE
SECUNDARIO O A GRANEL NO
ESTERIL W/O
MATERIA PRIMA
CONSTRUIR PRODUCTO
IMPRESION DE ROTULO
VERIFICACION DE CODIGO DE
BARRAS
REQUIERE CONTROL DE
CALIDAD FINAL ?
CONSTRUIR SUB ENSAMBLES
SI
VERIFICACION DE CODIGO DE CONTROL DE CALIDAD DE PRODUCTO TERMINADO

BARRAS
NO
EMPACADO
REQUIERE
CONTROL DE
CALIDAD
FINAL ?
SI SI
CONTROL DE CALIDAD DE PRODUCTO TERMINADO REQUIERE ENCAJADO

NO
EMPAQUE
NO
CUARTO DE IMPRESION DEL STOCK O ENSAMBLAJE
SECUNDARIO O A GRANEL NO ESTERIL W/O CONTROL DE CALIDAD DEL
CONTROL DE CALIDAD DE ENCAJADO
EMPAQUE
LIBERACION DE LOTE
REQUIERE
ESTERILIZACIO
N
PARA
SI
PRODUCCION/CLIENTE
CLIENTE
C.C. POST ESTERILIZACION Y
LIBERACION
ENVIAR AL CLIENTE BUEN ALMACENAMIENTO

DE PRODUCTO TERMINADO
SI
REQUIERE
EMPAQUE
DE
ALUMINIO
CC EMPACADO DE ALUMINIO
NO
REQUIERE SI ENCAJADO
ENCAJADO
C.C ENCAJADO
LIBERACION DE LOTES (INCLUYE PRUEBA

ANALITICA) SI REQUIERE
TRADUCCION SIMPLE
Sección 7.0
Información de Fabricación
Stents Metalicos/
Juegos
ITF049-MSS
7.0 Información de Fabricación
Se crea un registro maestro de dispositivos a pedido para cada producto a través de D00059884 (QSI1601),
Compilación de registros maestros de dispositivos y registros de historial de dispositivos. Los registros maestros
de dispositivos son mantenidos por el Departamento de control de documentos/Gestión del ciclo de vida del
producto (PLM).
El flujo básico de fabricación desde la recepción de las materias primas hasta el almacenamiento para su
distribución se describe a continuación:
Las materias primas se reciben e inspeccionan en Cook Ireland. Después de la inspección y aprobacion del
ingreso, las materias primas se almacenan en el área de almacenamiento de materias primas.
Las materias primas se distribuyen a cada área de fabricación, según órdenes de trabajo individuales para el
montaje, inspección y envasado y etiquetado del producto terminado. Después de la inspección final, el envasado
y el etiquetado, los productos no estériles se envían directamente al almacén de productos terminados, mientras
que los productos destinados a la esterilización se envían a Synergy Health Ireland Ltd., una empresa de STERIS.
Después de la esterilización, los productos regresan a Cook Ireland, donde después de la confirmación de la
esterilización, los productos se transfieren a nuestra tienda de productos terminados.
Los proveedores se controlan y clasifican según D00059409 (QSP0600), Aprobación y compras de proveedores.
Consulte el Apéndice E para ver el diagrama de flujo de fabricación, que describe el proceso.
Megha Bhapkar (DV0001519) 11 May 2020 (DV0001519)
Asuntos Regulatorios Fecha

TRADUCCION SIMPLE
APENDICE E: DIAGRAMA DE FLUJO DE PROCESO DE MANUFACTURA DE COOK IRLAND LTD.

ITF049-MSS Metal Stents/ Sets
DIAGRAMA DE FLUJO 1: - Proceso de Manufactura Cook Ireland

FLUJO DE
Area de Almacenamiento \ FLUJO DEL
PROCESO DE
PROCESO DE ENSAMBLAJE SECUNDARIO
PRODUCTO
e.g. dilatadores /solamente stents, FLLAs
TERMINADO
ALMACENAMIENTO DE
ÁREA DE IMPRESION DEL STOCK PRODUCTO TERMINADO
O ENSAMBLAJE SECUNDARIO O (BPA)
A GRANEL NO ESTERIL
ARMAR PRODUCTO MATERIA PRIMA

IMPRESION DE
ETIQUETAS
BARRAS
ARMAR SUB
COMPONENTES REQUIERE CONTROL DE
CALIDAD FINAL ?
PRODUCCION
SI
BARRAS CONTROL DE CALIDAD DE PRODUCTO TERMINADO NO
EMPACADO
REQUIERE
CONTROL DE
CALIDAD FINAL ?
REQUIERE
EMPAQUE SI EMBALAJE EN CAJA
REQUERIDO
SI
CONTROL DE CALIDAD DE PRODUCTO

NO
TERMINADO
CONTROL DE CALIDAD DE EMPAQUE CONTROL DE CALIDAD DE EMBALAJE
DE CAJA
NO
ÁREA DE IMPRESION DEL STOCK O

ENSAMBLAJE SECUNDARIO O A GRANEL NO
REQUIERE
ESTERIL
ESTERILIZACION
SI
LIBERACION DE LOTE CONTRATO DE ESTERILIZACION
C.ONTROL DE CALIDAD . POST

PARA ESTERILIZACION Y LIBERACION
PRODUCCION/CLIENTE
TRADUCCION SIMPLE
NO
EMPACADO DE ALUMINIO
REQUIERE EMPAQUE
PARA DE ALUMINIO
PRODUCCION/CLIENTE
CC EMPACADO DE ALUMINIO
CLIENTE NO
SI ENCAJADO
REQUIERE
EMBALAJE
EN CAJA
ALMACENAMIENTO DE
ENVIAR AL CLIENTE
PRODUCTO TERMINADO C.C ENCAJADO
(BPA)
NO
LIBERACION DE LOTES (INCLUYE PRUEBA

ANALITICA) SI SE REQUIERE
IDENTIFICACIÓN DEL EXPEDIENTE TÉCNICO ITF049-MSS F3203D (Lista de requisitos esenciales) Página 1 de 17
Requisitos esenciales A- Normas de referencia Lista de Cumplimiento de los Ubicación

N/A normas fabricantes
I REQUISITOS GENERALES
1 Los productos deberán diseñarse y fabricarse de modo que, cuando A EN ISO 13485 Productos sanitarios Manual de calidad Control de documentos /
se utilicen en las condiciones y para los fines previstos, no Productos sanitarios - Sistemas de Certificado EN ISO 13485 - Sistemas Gestión del ciclo de vida
comprometan el estado clínico ni la seguridad de los pacientes , ni gestión de la calidad - Requisitos de gestión de la calidad de los del producto (PLM).
la seguridad y la salud de los usuarios o, en su caso, de otras para fines reglamentarios productos sanitarios
personas, siempre que los riesgos que puedan estar asociados a su
uso previsto constituyan riesgos aceptables si se sopesan con los EN ISO 14971 Productos sanitarios Declaración de riesgo
beneficios para el paciente y sean compatibles con un nivel Productos sanitarios - Aplicación de Resumen de Validación y Archivo del historial de
elevado de protección de la salud y la seguridad. la gestión de riesgos a los productos Verificación del Diseño Evaluación diseño, archivo técnico,
Esto incluirá: sanitarios Clínica / Informes de Evidencia Control de documentos /
-la reducción, en la medida de lo posible, del riesgo de error de uso Declaración de Etiquetado. PLM.
debido a las características ergonómicas del producto y al entorno EN 1041:
en el que está previsto utilizarlo (diseño para la seguridad del Información suministrada por el QSP0400 (D00059388)
paciente), y fabricante de productos sanitarios Procedimiento de control de diseño Control de documentos /
-la consideración de los conocimientos técnicos, la experiencia, la QSP0900 (D00059418) Control de PLM.
educación y la formación y, en su caso, las condiciones médicas y EN 556-1 Esterilización de fabricación
físicas de los usuarios previstos (diseño para usuarios no productos sanitarios - Requisitos QSP0940 (D00059428) Validación
profesionales, profesionales, discapacitados u otros) para que los productos sanitarios del proceso
sean designados "ESTÉRIL". QSPl000 (D00059458)
Parte 1: Requisitos para los Procedimiento de inspección de
productos sanitarios esterilizados en entrada
su fase final QSP3100 (D00059520) Control de
etiquetas
EN ISO 11607-1 QSP3020 (D00059514) Informes de
Embalaje para productos sanitarios evaluación clínica (CER)
esterilizados en su fase final: QSP1500 (D00059500)
Requisitos de los materiales, Manipulación, almacenamiento,
sistemas de barrera estéril y envasado, conservación y envío.
sistemas de envasado
EN ISO 11607-2
Embalaje para productos sanitarios
esterilizados en su fase final - Parte
2: Requisitos de validación de los
procesos de formación, sellado y
montaje.
2 Las soluciones adoptadas por el fabricante para el diseño y la A EN ISO 13485 Dispositivos Manual de calidad Control de documentos /
construcción de los productos deberán ser conformes a los médicos - Sistemas de gestión de la Certificado EN ISO 13485 - Sistemas PLM.
principios de seguridad, teniendo en cuenta el estado de la técnica calidad - Requisitos para fines de gestión de la calidad de los
generalmente reconocido. reglamentarios productos sanitarios
DOCUMENTO CONFIDENCIAL Formato: F3203D (V34, CRI 7-0241) DOCUMENTO CON DERECHO DE AUTOR

En la selección de las soluciones más adecuadas, el fabricante debe EN ISO 14971 Dispositivos Declaración de riesgo Archivo del historial de
aplicar los siguientes principios en el siguiente orden: médicos Resumen de la validación y diseño, archivo técnico,
Eliminar o reducir los riesgos en la medida de lo posible (diseño y - Aplicación de la gestión de verificación del diseño Informes de Control de documentos /
construcción intrínsecamente seguros), adoptar, en su caso, las riesgos a los productos sanitarios evaluación/evidencia clínica PLM.
medidas de protección adecuadas, incluidas las alarmas si fuera Declaración de etiquetado - Nota 1
necesario, en relación con los riesgos que no puedan eliminarse, EN 1041
informar a los usuarios de los riesgos residuales debidos a las Información suministrada por el
posibles deficiencias de los métodos de protección adoptados. fabricante de dispositivos médicos. QSP0400 (D00059388) Control de documentos /
Procedimiento de control de diseño PLM
EN ISO 11607-1 QSP3100 (D00059520) Control de
Embalaje para productos sanitarios etiquetas
esterilizados en fase terminal - QSP3020 (D00059514) Informes de
Parte 1: Requisitos de los Evaluación Clínica (IEC)
materiales, sistemas de barrera QSP0940 (D00059428) Validación
estéril y sistemas de envasado. del proceso
QSPl000 (D00059458)
EN ISO 11607-2 Procedimiento de inspección de
Parte 2: Requisitos de validación entrada
para los procesos de formación, QSP1500 (D00059500)
sellado y ensamblaje. Manipulación, almacenamiento,
envasado, conservación y envío.
3 Los productos deberán alcanzar las prestaciones previstas por el A EN ISO 13485 Dispositivos Manual de calidad Control de documentos /
fabricante y estar diseñados, fabricados y envasados de forma que médicos Certificado EN ISO 13485 -Sistemas PLM.
sean adecuados para una o varias de las funciones contempladas en - Sistemas de gestión de la calidad - de gestión de la calidad de los
la letra a) del apartado 2 del artículo 1, según lo especificado por el Requisitos para fines dispositivos médicos
fabricante. reglamentarios
Resumen de la Declaración de Riesgo Archivo del historial de
EN ISO 14971 Dispositivos de Validación y Verificación del diseño, archivo técnico,
médicos Diseño Informes de Evaluación control de documentos /
- Aplicación de la gestión de Clínica / Evidencia PLM.
riesgos a los productos sanitarios
EN ISO 11607-1 QSP0900 (000059418) Control de Control de documentos /

Embalaje para dispositivos médicos fabricación PLM
esterilizados en fase terminal - QSP0920 (000059425) Conservación
Parte 1: Requisitos de los de las áreas de fabricación controlada
materiales, sistemas de barrera QSP0940 (D00059428) Validación
estéril y sistemas de envasado del proceso
QSP1500 (D00059500)
EN ISO 11607-2 Manipulación, almacenamiento,
envasado, conservación y envío.

Embalaje para dispositivos médicos QSPl000 (D00059458)

esterilizados en su fase final - Parte Procedimiento de inspección de
2: Requisitos de validación para los entrada
procesos de formación, sellado y QSP3020 (D00059514) Informes de
ensamblaje. evaluación clínica (IEC)
QSP1400 (D00059485) Acciones
correctivas y preventivas
QSP0400 (D00059388)
Procedimiento de control de diseño
4 Las características y prestaciones contempladas en los puntos 1, 2 A EN ISO 13485 Dispositivos Manual de calidad Control de documentos /
y 3 no deberán verse afectadas de tal manera que las condiciones médicos - Sistemas de gestión de la Certificado EN ISO 13485 -Calidad PLM.
clínicas y la seguridad de los pacientes y, en su caso, de otras calidad - Requisitos para fines de los dispositivos médicos
personas se vean comprometidas durante la vida útil del producto regulatorios. de Productos Médicos
indicada por el fabricante, cuando el producto esté sometido a las
tensiones que puedan producirse en condiciones normales de EN ISO 14971 Dispositivos Declaración de riesgo Archivo del historial de
utilización. médicos - Aplicación de la gestión Resumen de la validación y diseño, Expediente
de riesgos a los dispositivos verificación del diseño clínico técnico,
médicos Informes de evaluación/evidencia Control de documentos /
PLM.
EN ISO 11607-1
Embalaje para dispositivos médicos QSP3020 (D00059514) Informes de
esterilizados en fase terminal - evaluación clínica (CER) Control de documentos /
Parte 1: Requisitos de los QSP1400 (D00059485) Acciones PLM.
materiales, sistemas de barrera correctivas y preventivas
estéril y sistemas de envasado QSP0900 (D00059418) Control de
fabricación
EN ISO 11607-2 QSP0400 (D00059388)
Embalaje para dispositivos médicos Procedimiento de control de diseño
esterilizados en su fase final - Parte QSP0920 (D00059425) Conservación
2: Requisitos de validación para los de áreas de fabricación controladas
procesos de formación, sellado y QSP0940 (D00059428) Validación
ensamblaje del proceso
QSP1500 (D00059500)
Manipulación, Almacenamiento,
Embalaje, Conservación y envío.
QSP1000 (D00059458)
Procedimiento de inspección de
entrada
5 Los productos deberán diseñarse, fabricarse y envasarse de forma A EN ISO 13485 Dispositivos Declaración de etiquetado Control de documentos/
que sus características y prestaciones durante el uso previsto no se médicos - Sistemas de gestión de la Resumen de la validación y PLM
vean afectadas negativamente durante el transporte y el verificación del diseño

almacenamiento, teniendo en cuenta las instrucciones y la calidad - Requisitos para fines Archivo del historial de
información facilitada por el fabricante. reglamentarios. QSP0900 (D00059418) Control de diseño, archivo técnico
fabricación
EN 1041 Información suministrada QSP0920 (D00059425) Conservación
por el fabricante de productos de las áreas de fabricación controlada Control de documentos/
sanitarios QSP0940 (D00059428) Validación PLM
dispositivos médicos. del proceso
QSP1500 (D00059500)
EN ISO 14971 Dispositivos Manipulación, almacenamiento,
médicos - Aplicación de la gestión embalaje, conservación e
de riesgos a los dispositivos implantación
médicos QSP0400 (D00059388)
Procedimiento de control de diseño
EN ISO 11607-1 Embalaje para QSPl000 (D00059458)
dispositivos médicos esterilizados Procedimiento de inspección de
en fase terminal - Parte 1: entrada
Requisitos de los materiales, QSP3100 (D00059520) Control de
sistemas de barrera estéril y etiquetas
sistemas de envasado QSP1400 (D00059485) Acciones
correctivas y preventivas
EN ISO 11607-2 Embalaje para
dispositivos médicos esterilizados
en su fase final - Parte 2: Requisitos
de validación para los procesos de
formación, sellado y montaje
6 Cualquier efecto secundario indeseable debe constituir un riesgo A En ISO 14971 Evaluación clínica de la declaración Archivo del historial de
aceptable si se compara con las prestaciones previstas Dispositivos médicos-aplicación de de riesgos/Informes de pruebas diseño, archivo técnico
la gestión de riesgos a los Control de documentos/
dispositivos médicos QSP3020 (D00059514) Informes de PLM
evaluación clínica (IEC)
QSP04000 (D00059388)
Procedimiento de control de diseño Control de documentos /
PLM
6.a La demostración de la conformidad con los requisitos esenciales A N/A Informes de evaluación Archivo del historial de
debe incluir una evaluación clínica con arreglo al anexo X. clínica/evidencia diseño, archivo técnico
QSP3020 (D00059514) Informes de

evaluación clínica (IEC) Control de documentos /
PLM
II REQUISITOS DE DISEÑO Y CONSTRUCCIÓN

7 Propiedades químicas, físicas y biológicas

7.1 Los dispositivos deberán diseñarse y fabricarse de forma que se A EN ISO 10993-1 Evaluación Resumen de la declaración de riesgo Archivo del historial de
garanticen las características y prestaciones mencionadas en el biológica de dispositivos médicos - de validación y verificación del diseño, archivo técnico
apartado 1 sobre los "Requisitos generales". Se prestará especial Parte 1: Evaluación y pruebas diseño
atención a: la elección de los materiales utilizados, en particular en dentro de un proceso de gestión de
lo que respecta a la toxicidad y, en su caso, a la inflamabilidad la riesgos. QSP0900 (D00059418) Control de Control de documentos /
compatibilidad entre los materiales utilizados y los tejidos fabricación. PLM
biológicos, las células y los fluidos corporales, teniendo en cuenta QSP0920 (D00059425) Preservación
la finalidad prevista del producto, en su caso, los resultados de las de las áreas de fabricación controlada
investigaciones biofísicas o de modelización cuya validez se haya QSI3202 (D00059976)
demostrado previamente Procedimiento de biocompatibilidad
QSI3201 (D00059974)
Procedimiento de evaluación de la
esterilización y la microbiología para
la adopción de productos
QSP0400 (D00059388)
Procedimiento de control del diseño
7.2 Los productos deberán diseñarse, fabricarse y envasarse de forma A EN ISO 10993-1 Evaluación Resumen de la declaración de riesgo Archivo del historial de
que se reduzca al mínimo el riesgo que suponen los contaminantes biológica de dispositivos médicos - de validación y verificación del diseño, archivo técnico
y los residuos para las personas que participan en el transporte, el Parte 1: Evaluación y pruebas diseño
almacenamiento y la utilización de los productos y para los dentro de un proceso de gestión de
pacientes, teniendo en cuenta la finalidad prevista del producto. riesgos. QSP0900 (D00059418) Control de Control de documentos /
Debe prestarse especial atención a los tejidos expuestos y a la fabricación. PLM
duración y frecuencia de la exposición. EN ISO 10993-7 QSP0920 (D00059425) Preservación
Evaluación biológica de los de las áreas de fabricación controlada
dispositivos médicos - Parte 7: QSI3202 (D00059976)
Residuos de esterilización por Procedimiento de biocompatibilidad
óxido de etileno.
QSI1021 (D00059819) Pruebas de
EN ISO 11737-1 residuos de óxido de etileno del
Esterilización de productos producto
sanitarios - Métodos QSP1500 (D00059500)
microbiológicos - Parte 1: Manipulación, almacenamiento,
Determinación de la población de envasado, conservación e
microorganismos en los productos implantación
QSP0400 (D00059388)
EN ISO 14971 Procedimiento de control de diseño
Dispositivos médicos - Aplicación
de la gestión de riesgos a los
dispositivos médicos

7.3 Los productos deberán diseñarse y fabricarse de forma que puedan A EN ISO 14971 Dispositivos Declaración de etiquetado Archivo del historial de
utilizarse con seguridad con los materiales, sustancias y gases con médicos - Aplicación de la gestión Declaración de riesgo diseño, archivo técnico
los que entren en contacto durante su uso normal o durante los de riesgos a los dispositivos Resumen de la validación y
procedimientos rutinarios. médicos verificación del diseño
QSP0900 (D00059388) Control de Control de documentos /
Si los productos se destinan a la administración de medicamentos, N/A fabricación. PLM
deberán diseñarse y fabricarse de modo que sean compatibles con QSP0400 (D00059418)
los medicamentos de que se trate, de acuerdo con las disposiciones Procedimiento de control de diseño
y restricciones que rigen dichos productos, y que su rendimiento se
mantenga de acuerdo con el uso previsto.
7.4 Cuando un producto incorpore, como parte integrante, una N/A N/A Estos productos no contienen un N/A
sustancia que, si se utiliza por separado, pueda considerarse un medicamento que pueda actuar sobre
medicamento tal como se define en el artículo 1 de la Directiva el organismo con una acción
2001/83/CE y que pueda ejercer en el organismo una acción accesoria a la del producto.
accesoria a la del producto, la calidad, seguridad y utilidad de la Estos productos no contienen un
sustancia deberán verificarse por analogía con los métodos derivado de la sangre humana.
especificados en el anexo I de la Directiva 2001/83/CE.
En el caso de las sustancias contempladas en el párrafo primero, el

organismo notificado, una vez verificada la utilidad de la sustancia
como parte del producto sanitario y teniendo en cuenta la finalidad
prevista del producto, solicitará un dictamen científico a una de las
autoridades competentes designadas por los Estados miembros o a
la Agencia Europea de Medicamentos (EMEA), actuando en
particular a través de su comité, de conformidad con el
Reglamento (CE) no 726/2004 (1), sobre la calidad y la seguridad
de la sustancia, incluido el perfil clínico beneficio/riesgo de la
incorporación de la sustancia al producto. Al emitir su dictamen, la
autoridad competente o la EMEA tendrán en cuenta el proceso de
fabricación y los datos relativos a la utilidad de la incorporación de
la sustancia en el producto, tal como lo determine el organismo
notificado.
Cuando un producto incorpore, como parte integrante, una

sustancia derivada de la sangre humana, el organismo notificado,
una vez verificada la utilidad de la sustancia como parte del
dispositivo médico y teniendo en cuenta la finalidad prevista del
producto, solicitará un dictamen científico a la EMEA, actuando
en particular a través de su comité, sobre la calidad y la seguridad
de la sustancia, incluido el perfil clínico de beneficio/riesgo de la
incorporación de la sustancia derivada de la sangre humana en el

producto. Al emitir su dictamen, la EMEA tendrá en cuenta el

proceso de fabricación y los datos relativos a la utilidad de la
incorporación de la sustancia en el producto, tal como lo determine
el organismo notificado.
Cuando se introduzcan cambios en una sustancia accesoria

incorporada a un producto, en particular en relación con su proceso
de fabricación, se informará al organismo notificado de los
cambios y se consultará a la autoridad competente en materia de
medicamentos (es decir, la que haya participado en la consulta
inicial), para confirmar que se mantienen la calidad y la seguridad
de la sustancia accesoria. La autoridad competente tendrá en
cuenta los datos relativos a la utilidad de la incorporación de la
sustancia en el producto, tal como haya determinado el organismo
notificado, con el fin de garantizar que los cambios no tienen un
impacto negativo en el perfil establecido de beneficios/riesgos de
la adición de la sustancia en el dispositivo médico.
Cuando la autoridad competente en materia de medicamentos (es

decir, la que haya participado en la consulta inicial) haya obtenido
información sobre la sustancia accesoria, que podría tener un
impacto en el perfil de riesgo/beneficio establecido de la adición
de la sustancia en el producto sanitario, deberá asesorar al
organismo notificado sobre si esta información tiene un impacto en
el perfil de riesgo/beneficio establecido de la adición de la
sustancia en el producto sanitario o no. El organismo notificado
tendrá en cuenta el dictamen científico actualizado al reconsiderar
su evaluación del procedimiento de evaluación de la conformidad.
7.5 Los productos deberán diseñarse y fabricarse de forma que se A EN ISO 14971 Resumen de la declaración de riesgo Archivo del historial de
reduzcan al mínimo los riesgos que suponen las sustancias que se Dispositivos médicos de validación y verificación del diseño, archivo técnico.
escapan del producto. Se prestará especial atención a las sustancias Aplicación de la gestión de riesgos diseño de declaración de etiquetado -
cancerígenas, mutágenas o tóxicas para la reproducción, de a los dispositivos médicos Nota 1
conformidad con el Anexo I de la Directiva 67/548/CEE del Control de documentos /
Consejo, de 27 de junio de 1967, relativa a la aproximación de las EN ISO 10993-7 QSP0900 (D00059418) Control de PLM.
disposiciones legales, reglamentarias y administrativas en materia Evaluación biológica de los fabricación.
de clasificación, embalaje y etiquetado de las sustancias peligrosas dispositivos médicos - Parte 7: QSP0400 (D00059388)
(1). Residuos de esterilización por Procedimiento de control de diseño
óxido de etileno QSP3100 (D00059520) Control de la
Si las partes de un producto (o el propio producto) destinadas a N/A etiqueta
administrar y/o extraer medicamentos, líquidos corporales u otras QSI0801 (D00059640) Asignación
sustancias hacia o desde el del número de material del producto

del cuerpo, o los productos destinados al transporte y EN 1041 Información suministrada QSI3201 (D00059974)
almacenamiento de dichos líquidos corporales o sustancias, por el fabricante de dispositivos Procedimiento de evaluación de la
contienen ftalatos clasificados como carcinógenos, mutágenos o médicos esterilización y la microbiología para
tóxicos para la reproducción, de categoría 1 o 2, de conformidad la adopción del producto
con el Anexo I de la Directiva 67/548/CEE, estos productos EN ISO 10993-1 QSI1021 (D00059819) Óxido de
deberán ser etiquetados en el propio producto y/o en el envase de Evaluación biológica de los etileno del producto
cada unidad o, en su caso, en el envase de venta como producto dispositivos médicos - Parte 1: Prueba de residuos
que contiene ftalatos. Evaluación y pruebas dentro de un QSI3202 (D00059976)
proceso de gestión de riesgos Procedimientos de biocompatibilidad
Si el uso previsto de estos productos no incluye el tratamiento de N/A
niños o de mujeres embarazadas o en período de lactancia, el
fabricante deberá proporcionar una justificación específica del uso Evaluaciones completadas para
de estas sustancias en relación con el cumplimiento de los dispositivos en CMR's
requisitos esenciales, en particular del presente apartado, dentro de
la documentación técnica y, dentro de las instrucciones de uso,
información sobre los riesgos residuales para estos grupos de
pacientes y, en su caso, sobre las medidas de precaución
adecuadas.
7.6 Los productos deberán diseñarse y fabricarse de forma que se N/A N/A Estos dispositivos están diseñados N/A
reduzcan, en la medida de lo posible, los riesgos derivados de la (Prod para su uso previsto, que implica la
entrada involuntaria de sustancias en el producto, teniendo en ucto, entrada de sustancias. Estos
cuenta el producto y la naturaleza del entorno en el que está excep dispositivos no están sellados
destinado a utilizarse. to el herméticamente.
embal
aje)
A EN ISO 14971 Dispositivos Resumen de la declaración de riesgo Archivo del historial de

(Emb médicos - Aplicación de - Gestión de validación y verificación del diseño, archivo técnico.
alaje) de riesgos a los dispositivos diseño
médicos
Control de documentos /
EN ISO 11607-1 QSP0400 (D00059388), PLM.
Embalaje para dispositivos médicos Procedimiento de control de diseño
esterilizados en fase terminal - QSP0900 (D00059418), Control de
Parte 1: Requisitos de los fabricación
materiales, sistemas de barrera QSP0920 (D00059425), Preservación
estéril y sistemas de envasado de las áreas de fabricación
controladas
EN ISO 11607-2 QSP0940 (D00059428), Validación
Embalaje para dispositivos médicos del Proceso
esterilizados en su fase final - Parte

2: Requisitos de validación para los QSI0957 (D00059773), Monitoreo,

procesos de formación, sellado y de Operación y Mantenimiento del
montaje. Sistema de Agua de Proceso
QSP1020 (D00059463), Revisión de
la esterilización e inspección post
estéril
QSP1500 (D00059500),
Manipulación, almacenamiento,
embalaje, conservación y envío
8 Infección y contaminación microbiana.
8.1 Los productos y los procesos de fabricación deben diseñarse de A EN ISO 11737-1 Resumen de la declaración de riesgo Archivo del historial de
forma que se elimine o reduzca al máximo el riesgo de infección Esterilización de productos de validación y verificación del diseño, archivo técnico.
para el paciente, el usuario y terceros. El diseño debe permitir una sanitarios - Métodos diseño
fácil manipulación y, cuando sea necesario, minimizar la microbiológicos
contaminación del producto por el paciente o viceversa durante su - Parte 1: Determinación de la Control de documentos /
uso. población de QSP0900 (D00059418) Control de la PLM
microorganismos en los productos fabricación
QSP0920 (D00059425) Conservación
EN ISO 11135 de las áreas de fabricación
Esterilización de productos controladas
sanitarios - Óxido de etileno: QSP0940 (D00059428) Validación
Requisitos para el desarrollo, la del proceso
validación y el control de rutina de QSP1020 (D00059463) Revisión de
un proceso de esterilización para la esterilización e inspección post
dispositivos médicos estéril
QSP0400 (D00059388)
EN 556-1 Esterilización de Procedimiento de control de diseño
productos sanitarios - Requisitos QSI0957 (D00059773) Supervisión,
para que los productos sanitarios operación y mantenimiento del
sean designados "ESTÉRIL" - Parte sistema de agua de proceso.
1: Requisitos para los dispositivos
médicos esterilizados en fase
terminal
EN ISO 14644-1
Salas limpias y ambientes
controlados asociados - parte 1
clasificación de la limpieza del aire
por concentración de partículas.
EN ISO 14644-2

Salas limpias y entornos

controlados asociados - Parte 2:
Monitorización para proporcionar
evidencia del rendimiento de la sala
limpia en relación con la limpieza
del aire por concentración de
partículas
EN IS014971
Dispositivos médicos Aplicación de
la gestión de riesgos a los
dispositivos médicos.
8.2 Los tejidos de origen animal deberán proceder de animales que N/A N/A Estos productos no contienen tejidos N/A
hayan sido sometidos a controles y vigilancia veterinarios de origen animal.
adaptados al uso previsto de los tejidos.
Los organismos notificados conservarán información sobre el

origen geográfico de los animales.
El procesamiento, la preservación, la experimentación y la

manipulación de los tejidos, las células y las sustancias de origen
animal deberán realizarse de forma que ofrezcan una seguridad
óptima. En particular, la seguridad con respecto a los virus y otros
agentes transmisibles deberá abordarse mediante la aplicación de
métodos validados de eliminación o inactivación viral en el curso
del proceso de fabricación.
8.3 Los productos suministrados en estado estéril deberán diseñarse, A EN ISO 11135 Resumen de la declaración de Archivo del historial de
fabricarse y envasarse en un envase no reutilizable y/o con arreglo Esterilización de productos etiquetado de validación y diseño, archivo técnico.
a los procedimientos adecuados para garantizar que sean estériles sanitarios - Óxido de etileno: verificación del diseño
cuando se comercialicen y que sigan siendo estériles, en las Requisitos para el desarrollo, la
condiciones de almacenamiento y transporte indicadas, hasta que validación y el control de rutina de Control de documentos /
se dañe o abra el envase protector. un proceso de esterilización para QSP0900 (D00059418) Control de la PLM.
dispositivos médicos fabricación
QSP0920 (D00059425) Conservación
EN ISO 11607-1 de las áreas de fabricación
Embalaje para dispositivos médicos controladas
esterilizados en fase terminal - QSP0940 (D00059428) Validación
Parte 1: Requisitos de los del proceso
materiales, sistemas de barrera QSP0400 (D00059388)
estéril y sistemas de envasado Procedimiento de control de diseño

EN ISO 11607-2 QSP1020 (D00059463) Revisión de

Parte 2: Requisitos de validación la esterilización e inspección post
para los procesos de formación, estéril.
sellado y montaje. QSP1500 (D00059500)
Manipulación, Almacenamiento,
Embalaje, Conservación y envío.
QSP3100 (D00059520) Control de
etiquetas
8.4 Los productos suministrados en estado estéril deben haber sido A EN ISO 11135 Resumen de la validación y Archivo del historial de
fabricados y esterilizados mediante un método adecuado y Esterilización de productos verificación del diseño diseño, archivo técnico
validado. sanitarios - Óxido de etileno:
Requisitos para el desarrollo, la Control de documentos /
validación y el control rutinario de QSP1020 (D00059463) Revisión de PLM.
un proceso de esterilización para la esterilización e inspección post
dispositivos médicos. estéril
QSP0940 (D00059428) Validación
EN 556-1: del proceso
Esterilización de productos QSP0920 (D00059425) Conservación
sanitarios. Requisitos para que los de las áreas de fabricación controlada
productos sanitarios se denominen QSP0900 (D00059418) Control de la
"ESTÉRIL". Parte 1: Requisitos fabricación
para los dispositivos médicos
esterilizados en fase terminal
8.5 Los productos destinados a ser esterilizados deben fabricarse en A EN ISO 11737-1 QSP0920 (D00059425) Conservación Control de documentos /
condiciones controladas adecuadas (por ejemplo, ambientales). Esterilización de productos de las áreas de fabricación controlada PLM.
sanitarios - Métodos QSP0900 (D00059418) Control de la
microbiológicos - Parte 1: fabricación
Determinación de una población de
microorganismos en los productos
EN ISO 14644-1
controlados asociados - Parte 1:
Clasificación de la limpieza del aire
por concentración de partículas
EN ISO 14644-2
controlados asociados -Parte 2:
Monitorización para evidencia del

rendimiento de la sala limpia en

relación con la limpieza del aire por
concentración de partículas
8.6 Los sistemas de envasado de los productos no estériles deben N/A N/A Estos dispositivos se suministran N/A
mantener el producto sin deterioro en el nivel de limpieza estériles, desechables y destinados a
estipulado y, si los productos deben ser esterilizados antes de su un solo uso. No están destinados a ser
uso, minimizar el riesgo de contaminación microbiana; el sistema esterilizados por el usuario final.
de envasado debe ser adecuado teniendo en cuenta el método de
esterilización indicado por el fabricante.
8.7 El envase y/o la etiqueta del producto deben distinguir entre N/A N/A Estos dispositivos sólo se suministran N/A
productos idénticos o similares que se vendan tanto en estado estériles.
estéril como no estéril.
9 Construcción y propiedades ambientales
9.1 Si el producto está destinado a ser utilizado en combinación con A EN 1041 Información suministrada Resumen de la validación y Archivo del historial de
otros productos o equipos, toda la combinación, incluido el sistema por el fabricante de dispositivos verificación del diseño Declaración diseño, archivo técnico.
de conexión, deberá ser segura y no deberá perjudicar las médicos de riesgo Declaración de etiquetado
prestaciones especificadas de los productos. Cualquier restricción
de uso debe indicarse en la etiqueta o en las instrucciones de uso. EN ISO 15223-1 QSP0400 (D00059388) Control de documentos /
Dispositivos médicos - Símbolos a Procedimiento de control del diseño PLM.
utilizar en las etiquetas de los
dispositivos médicos, etiquetado e QSP3100 (D00059520) Control de
información a suministrar - Parte I: etiquetas
Requerimientos generales
EN ISO 14971
Productos sanitarios - Aplicación de
la gestión de riesgos a los productos
sanitarios
9.2 Los productos deberán diseñarse y fabricarse de forma que se EN ISO 14971 Resumen de la validación y Archivo del historial de
eliminen m minimicen en la medida de lo posible: Productos sanitarios - Aplicación de verificación del diseño Declaración diseño, archivo técnico.
• los riesgos de lesión, en relación con sus características A la gestión de riesgos a los productos de riesgo Declaración de etiquetado
físicas, incluida la relación volumen/presión, las sanitarios
dimensiones y, en su caso, las características ergonómicas QSP0400 (D00059388) Control de documentos /
Procedimiento de control del diseño PLM.
• los riesgos relacionados con las condiciones ambientales A
razonablemente previsibles, como los campos QSP0900 (D00059418) Control de la
magnéticos, las influencias eléctricas externas, las fabricación
descargas electrostáticas, la presión, la temperatura o las
variaciones de presión y aceleración QSP3100 (D00059520) Control de
etiquetas.

• los riesgos de interferencia recíproca con otros A Los dispositivos de esta ficha técnica
dispositivos utilizados normalmente en las permiten la obtención de imágenes
investigaciones o para el tratamiento administrado por RM. Las instrucciones de uso de
estos dispositivos proporcionan
• los riesgos derivados de la imposibilidad de N/A información sobre la seguridad y las
mantenimiento o calibración (como en el caso de los condiciones de obtención de
implantes), del envejecimiento de los materiales imágenes por RM.
utilizados o de la pérdida de precisión de cualquier El mantenimiento o la calibración no
mecanismo de medición o control. son aplicables a estos dispositivos.
Estos dispositivos no tienen ningún
mecanismo de control de medición.
9.3 Los productos deberán diseñarse y fabricarse de forma que se N/A N/A Estos dispositivos no son inflamables N/A
reduzcan al mínimo los riesgos de incendio o explosión durante su y no están destinados a ser expuestos
uso normal y en condiciones de fallo único. Debe prestarse a una sustancia inflamable.
especial atención a los dispositivos cuyo uso previsto incluya la
exposición a sustancias inflamables, que podrían causar
combustión.
10 Dispositivos con función de medición.
10. 1 Los productos con función de medición deberán diseñarse y N/A N/A Estos dispositivos no son aparatos de N/A
fabricarse de forma que proporcionen una precisión y estabilidad medida.
suficientes dentro de unos límites de precisión adecuados y
teniendo en cuenta la finalidad prevista del producto. Los límites
de precisión deberán ser indicados por el fabricante.
10. 2 La escala de medición, control y visualización deberá diseñarse de N/A N/A Estos dispositivos no son aparatos N/A
acuerdo con los principios ergonómicos, teniendo en cuenta la de medida.
finalidad prevista del producto.
10. 3 Las mediciones efectuadas por los productos con función de N/A N/A Estos dispositivos no son aparatos N/A
medición deberán expresarse en unidades legales conformes a las de medida.
disposiciones de la Directiva 80/181/CEE del Consejo, cuya última
modificación la constituye la Directiva 89/617/CEE.
11 Protección contra las radiaciones
11. 1 Generalidades
11. 1 Los productos se diseñarán y fabricarán de modo que la exposición N/A N/A Estos productos no tienen un N/A
. de los pacientes, usuarios y otras personas a las radiaciones se componente radiactivo.
1 reduzca al máximo compatible con la finalidad prevista, sin Estos dispositivos están diseñados
restringir la aplicación de los niveles adecuados especificados para únicamente para el uso al que están
fines terapéuticos y de diagnóstico. destinados y no están pensados para
emitir radiación.
11. 2 Radiación prevista

11. 2 Cuando los productos estén diseñados para emitir niveles N/A N/A Estos dispositivos no tienen un N/A
. peligrosos de radiación necesarios para un fin médico específico componente radiactivo.
1 cuyo beneficio se considere superior a los riesgos inherentes a la Estos dispositivos están diseñados
emisión, el usuario deberá poder controlar las emisiones. Dichos únicamente para su uso previsto y no
productos se diseñarán y fabricarán para garantizar la están destinados a emitir niveles
reproducibilidad y la tolerancia de los parámetros variables peligrosos de radiación
pertinentes.
j) cualquier instrucción especial de funcionamiento; A
k) cualquier advertencia y/o precaución que deba tomarse; A
l) el año de fabricación de los productos activos distintos de los l. Estos productos no son productos
contemplados en la letra e). Esta indicación podrá incluirse en el N/A activos.
número de lote o de serie;
m) En su caso, método de esterilización.

A
n) cuando se trate de un producto en el sentido del apartado 4 bis n. Estos dispositivos no contienen un
del artículo 1, la indicación de que el producto contiene una N/A derivado de la sangre humana.
sustancia derivada de la sangre humana.
13. Si la finalidad del producto no es evidente para el usuario, el A EN 1041 Información suministrada Declaración de etiquetado. Ficha técnica.
4 fabricante debe indicarlo claramente en la etiqueta y en las por el fabricante de dispositivos
instrucciones de uso. médicos Control de documentos /
QSP3100 (D00059520) Control de PLM.
etiquetas
13. Siempre que sea razonable y factible, los productos y componentes A EN 1041 Información suministrada QSP0900 (D00059418) Control de Control de documentos /
5 desmontables deberán estar identificados, en su caso por lotes, por el fabricante de dispositivos fabricación PLM.
para permitir una actuación adecuada para detectar cualquier médicos QSP3100 (D00059520) Control de
riesgo potencial que presenten los productos y componentes etiquetas
desmontables.
13. En su caso, las instrucciones de uso deberán contener las Ficha técnica.
6 siguientes indicaciones: Declaración de etiquetado - Nota 1
a) las indicaciones mencionadas en el punto 13.3, con A EN 1041 Información suministrada Control de documentos /
excepción de las letras d) y e); por el fabricante de dispositivos PLM.
médicos

b) las prestaciones mencionadas en el punto 3 y los posibles A QSP3100 (D00059520) Control de

efectos secundarios indeseables; etiquetas
c) si el producto debe instalarse con otros productos o A EN 556-1: Esterilización de

equipos médicos o conectarse a ellos para que funcionen dispositivos médicos Requisitos
de acuerdo con su finalidad, detalles suficientes sobre sus para los dispositivos médicos que
características para identificar los productos o equipos se designan como "ESTÉRIL" -
correctos que deben utilizarse para obtener una Parte 1: Requisitos para los
combinación segura; dispositivos médicos esterilizados
en su fase final
d) toda la información necesaria para verificar si el N/A
dispositivo está bien instalado y puede funcionar de d. Estos dispositivos no deben ser
forma correcta y segura, además de detalles sobre la instalados y no requieren
naturaleza y la frecuencia del mantenimiento y la mantenimiento y calibración.
calibración necesarios para garantizar que los dispositivos
funcionan de forma correcta y segura en todo momento;
e) cuando proceda, información para evitar determinados A

riesgos en relación con la implantación del dispositivo
f) la información relativa a los riesgos de interferencia A EN ISO 15223-1 f. Los dispositivos de esta ficha
recíproca que supone la presencia del producto durante Dispositivos médicos - Símbolos a técnica permiten la obtención de
investigaciones o tratamientos específicos utilizar en las etiquetas de los imágenes por RM. Las instrucciones
dispositivos médicos, etiquetado e de uso de estos dispositivos
g) las instrucciones necesarias en caso de que se dañe el A información a suministrar - Parte 1: proporcionan información sobre la
envase estéril y, en su caso, los detalles de los métodos Parte 1: Requisitos generales seguridad de la RMN y las
adecuados de reesterilización condiciones de obtención de
imágenes.
h) Si el producto es reutilizable, información sobre los N/A g. La IFU contiene información

procesos adecuados para permitir su reutilización, relevante relacionada con el embalaje
incluida la limpieza, la desinfección, el envasado y, en su dañado. Estos dispositivos no deben
caso, el método de esterilización del producto que se va a ser reesterilizados por el usuario
reesterilizar, así como cualquier restricción del número de final.
reutilizaciones. Cuando los productos se suministren con
la intención de ser esterilizados antes de su uso, las h. Los dispositivos se suministran
instrucciones de limpieza y esterilización deberán ser estériles y están destinados a un solo
tales que, si se siguen correctamente, el producto siga uso.
cumpliendo los requisitos de la sección I;

Si el producto lleva una indicación de que es de un solo

uso, la información sobre las características propias y los
factores técnicos conocidos por el fabricante que podrían
suponer un riesgo si si el producto se reutiliza. Si, de
conformidad con el punto 13.1, no se necesitan
instrucciones de uso, la información deberá ponerse a
disposición del usuario que la solicite;
N/A
i) Detalles de cualquier tratamiento o manipulación
adicional que sea necesario antes de que el producto i. Estos dispositivos se suministran
pueda utilizarse (por ejemplo, esterilización, montaje estériles y listos para su uso.
final, etc.);
N/A
j) En el caso de productos que emitan radiaciones con fines
médicos, detalles sobre la naturaleza, el tipo, la intensidad j. Estos dispositivos no emiten
y la distribución de estas radiaciones. Las instrucciones radiación.
de uso también deben incluir detalles que permitan al
personal médico informar al paciente sobre cualquier
contraindicación y cualquier precaución que deba
tomarse. Estas precisiones deben referirse en particular a
A
k) Las precauciones que deben tomarse en caso de
modificación de las prestaciones del aparato;
l) Las precauciones que deben tomarse en cuanto a la A l. Los dispositivos de esta ficha
exposición, en condiciones ambientales razonablemente técnica permiten la obtención de
previsibles, a campos magnéticos, influencias eléctricas imágenes por RM. Las instrucciones
externas, descargas electrostáticas, presión o variaciones de uso de estos dispositivos
de presión, aceleración, fuentes de ignición térmica, etc; proporcionan información sobre la
seguridad y las condiciones de
m) La información adecuada sobre el medicamento o los N/A obtención de imágenes por RM.
medicamentos que el producto en cuestión está destinado
a administrar, incluidas las posibles limitaciones en la m. Estos dispositivos no administran
elección de las sustancias que se van a suministrar sustancias medicinales.
n) Las precauciones que deben tomarse contra cualquier N/A n. No existen riesgos inusuales
riesgo especial e inusual relacionado con la eliminación relacionados con la eliminación de
del producto estos productos. Las instrucciones de
eliminación de los dispositivos se
N/A proporcionan en las instrucciones de
uso.

o) las sustancias medicinales o los derivados de la sangre

humana incorporados al producto como parte integrante, o. Estos productos no implican el uso
de conformidad con el punto 7.4 N/A de sustancias medicinales según el
apartado 7.4.
p) grado de precisión declarado para los productos con p. Estos dispositivos no son
función de medición. A dispositivos de medición.
q) la fecha de emisión o la última versión de las

instrucciones de uso.
Nota 1: Las actualizaciones del etiquetado están en proceso tras una revisión de riesgos y se implementarán a través de las órdenes de cambio nº C00039408, C00040932, C0004093 l y C00039483.
VER CR# FECHA VER CR# FECHA

o CR08-0074 31-Ene-08 1 CR09-0091 9-Feb-09
2 CRl 0-0223 9-Mar-10 3 CRl 0-0746 06-Sep-10
4 CRl 0-0919 2-Nov-10 5 CR12-0238 22-Mar-12
6 CR12-0405 21-May-12 7 CR12-0980 28-Dic-12
8 CR14-0151 27-Feb-14 9 C00078642 24-Abr-2020
Aprobado:
Section 4.0
Summary of Design Validation and Verification Documents
Metal Stents/ Sets

ITF049-MSS
4.0 Summary of Design Validation and Verification Documents
4.1 General
Design Validation and Verification testing for the products covered by this technical
file is outlined in the sections below (sections 4.2 to 4.8). This testing supports the
performance and safety of these devices as per the Essential Requirements for its
intended use (Appendix D).
4.2 Testing Plan

The overall plan of the products was developed through the COOK Ireland product
development process D00059388 (QSP0400). Design Control documentation is
maintained within the Design History File by the product development department.
The Design Validation and Verification testing was performed and/or co-ordinated by
COOK Ireland. Reference sections 4.3 to 4.8 for an overview of the testing performed
and supporting information.
Process Validation was examined as per D00059428 (QSP0940) Process Validation.

The manufacturing master validation plan is documented as per D00060554
(CHT0053) and D00060574 (CHT0204). The manufacturing master validation report
is documented as per D00060555 (CHT0054).
Product specifications are developed and verified by COOK Ireland. Manufacturing

instructions for the products are released through Cook Ireland document control
methods. Any changes, which might occur to the instructions and design, will be
processed through Cook Ireland change control methods as per D00059381
(QSP0200) Change control deviation and as per D00059388 (QSP0400) Design
Control procedure.
Current manufacturing and quality control procedures require an inspection of these

devices, per relevant documented instructions by trained personnel in order to ensure
the devices meet product specification requirements prior to release to distribution.
The current production system control procedures are designed to eliminate the
potential for errors and defects that might affect the safety, performance and integrity
of these devices. A flow chart of the production system is located in Appendix E.
Page 1 of 32
4.3 Laboratory Testing
The laboratory testing for the Evolution Esophageal Stent System partially covered
and fully covered share many of the same testing as shown in the following table:
Validation Number Description of Testing Partially Fully Fully

Covered Covered Covered
Version 1 Version 2
VAL07-0013 Rev 0 Joint Strength, dimensional and √ √ √
simulated use testing.
VAL07-0014 Rev 0 Deployment Testing. √ √ √
TST07-038
VAL07-0022 Rev 0 Corrosion Testing. √ √ √
VAL07-0027 Rev 0 Automated radial force testing. √
VAL07-0067 Rev 0 Radial sling fatigue testing. √
VAL07-0066 Rev 0 PPQ and handle design verification. √ √ √
*TST08-085 Testing of handle components. √ √ √
*VAL08-0058 Rev 0 Design verification testing of handle √ √ √
components.
*VAL08-0020 Rev 0 Validation of thread lock of FLLA √ √
port and torquing FLLA joint.
TST10-103 Verification of stent partial covering. √
*VAL07-0011 Rev 0 Transportation and packing integrity √ √ √
testing, Age testing.
VAL07-0012 Rev 0 Testing post aging – introducer. √ √ √
VAL07-0033 Rev 0 Design verification testing post aging √ √ √
VAL08-0042 Rev 0 Automated radial force testing. √
VAL09-0012 Rev 0 Deployment accuracy testing and √ √
dimensional testing.
VAL09-0020 Rev 0 Deployment – simulated use testing. √
VAL09-0058 Rev 0 Simulated use testing – Modified √
lasso loop design.
TST09-033 Corrosion resistance of the ultra high √ √
molecular weight polyethylene lasso.
TST09-073 Corrosion resistance of the PTFE √
impregnated polyester lasso loop.
VAL10-0070 Rev 0 Corrosion testing: Lasso loops √
Page 2 of 32
Version 1 Version 2
(Representative 10 weeks exposure)
Corrosion testing: Lasso loops √
VAL10-0071 Rev 0 (Representative 52 weeks exposure)
Corrosion testing: Stent membrane √
VAL11-022 Rev 0 (Representative 10 weeks exposure)
Tensile testing of lasso loops – post √
VAL10-0074 Rev 0 corrosion (representative 10 weeks).
Tensile testing of lasso loops – post √
VAL10-0075 Rev 0 corrosion (representative 52 weeks).
VAL10-0079 Rev 0 Tensile testing of the lasso loops. √
Tensile testing of lasso loops post 52 √
VAL11-0021 Rev 0 week fatigue testing.
VAL09-0055 Rev 0 Visual inspection and tensile strength √ √
testing of lasso loop material.
TST08-052 MRI compatibility. √ √ √
TST09-041 Accelerated age testing of the lasso √ √
loop material (UHMWPE).
TST09-074 Accelerated aging PTFE √
impregnated polyester lasso loop.
VAL10-0033 Rev 0 Accelerated age testing – lasso loops. √
VAL10-0034 Rev 0 Tensile testing – lasso loops post √
aging.
VAL08-0043 Rev 0 Radial sling fatigue testing. √ √
VAL10-0077 Rev 0 Radial sling fatigue testing. √
VAL11-0001 Rev 0 Functionality testing. √
Functionality testing – deployment √
VAL11-0019 Rev 0 and recapturing force.
Comparison of radial force testing √
VAL11-0020 Rev 0 versus predicate devices.
Measurement of stent dimensions √
VAL11-0023 Rev 0 post deployment, label verification.
Performance evaluation versus √
VAL11-0024 Rev 0 predicate devices.
*TST11-066 To verify FLLA dimensional √ √ √
Page 3 of 32
Version 1 Version 2
requirements.
*TST12-053 Labelling verification post aging. √ √ √
Table 4.1: Evolution Esophageal testing matrix
* The Evolution® Duodenal/Colonic stent system shares some of the design features of the
Evolution Esophageal Stent System. The reports highlighted above with an “*” are also
applicable to the Evolution® Colonic/ Duodenal Stent System. The reports highlighted in
Table 4.2 as ** indicate testing specific to the outer catheter- version 2 (IRE0045-K).
A summary of each of the Design verification and validation reports listed in tables 4.1 and
4.2 are included in Appendix I. The design history file documents the applicable testing.
Validation Number Description of Testing Duodenal Colonic

VAL07-0016 Rev 0 Deployment testing, stent dimensional testing, √ √
tensile strength testing
VAL08-0011 Rev 0 Deployment testing in a simulated clinical √ √
environment.
VAL08-0070 Rev 0 Deployment accuracy testing. √ √
VAL07-0028 Rev 0 Automated radial force testing. √ √
VAL07-0075 Rev 0 Sling radial fatigue testing. √ √
VAL07-0015 Rev 0 Immersion corrosion testing. √ √
TST08-043 Retrieval loop retention force. √ √
VAL08-0018 Rev 0 Validation of the Torquing and gluing of the Shuttle √ √
Cap.
VAL08-0049 Rev 0 Real time age testing. √ √
TST11-067 MRI Testing - Colonic. √
TST10-053 MRI Testing - Duodenal. √
VAL08-0024 Rev 0 Pouch sealing process √ √
NCT16-0036-R ** Simulated Use testing – Outer Catheter Version 2. √ √
NCT16-0079-R ** Tensile Strength Testing – Outer Catheter Version 2 √ √
Table 4.2: Evolution Duodenal/Colonic testing matrix
4.4 Biocompatibility
4.4.1 The Evolution® Esophageal Stent System
Page 4 of 32
Note: Standards are referenced as per test protocols. Compliance is only claimed for
standards referenced in Appendix H.
The intended use for the Evolution® Esophageal Stent Systems is outlined in section
3.2.
Evolution® Esophageal Stent System has two types of body contact according to EN
ISO10993-1. The two different types of body contact are experienced by the
Introducer and the Stent components of the Evolution® Esophageal System.
Both the Evolution® Esophageal Stent System-Partially Covered and Evolution®

Esophageal Stent System-Fully Covered share most of their raw materials. Unless
indicated to the contrary the raw materials listed in the tables below are common
across the Evolution® Esophageal range. Where “Note A” appears beside an RMN
number this indicates that the material is used in the Evolution® Esophageal Stent
System-Partially Covered. Where “Note B” appears beside an RMN number this
indicates that the material is used in the Evolution® Esophageal Stent System-Fully
Covered version 1. Where “Note C” appears beside an RMN number this indicates
that the material is used in the Evolution® Esophageal Stent System-Fully Covered
version 2.
The Evolution® Esophageal Fully Covered Stent system is a design modification of

the Evolution® Esophageal Stent System- Partially covered. Some of the testing for
the partially covered version is relevant to the fully covered version and was not
repeated.
Introducer
The Introducer section is an externally communicating device with tissue contact for a
limited duration. The patient contact for the introducer is likely to be less than one
hour. By EN ISO10993-1 a device with contact duration of <24 hours there is a
recommendation for the following tests:
• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous testing
All the testing recommended by EN ISO10993-1 was performed on the Introducer.

The Cytotoxicity testing on the introducer showed no evidence of cell lysis or toxicity
and the Sensitisation testing showed no delayed dermal contact sensitisation. For the
Intracutaneous testing there was very slight erythema and edema from the SO extract
injected intracutaneously into rabbits but the Introducer still met the requirements of
the test. A Biological Safety Assessment and Cytotoxicity testing supports the use of
the PTFE lining and the stainless steel collar.
See Table 4.3 for the Introducer biocompatibility test summary.
Page 5 of 32
RMN Description Material Patient Test Test Number
Contact
28-096 Introducer Pebax 3533 with 40% Yes Cytotoxicity Study NAMSA
system tip barium Using the ISO 07T_37792_02
(inner catheter) Elution Method
18-100 Tubing (inner Polyetheretherketone Yes
catheter)
15-274 Marker bands Platinum with 10% Yes
iridium ISO Maximisation NAMSA
18-122 Pusher (inner Polyethylene Yes Sensitization Study- 07T_37792_03
catheter) radiopaque tubing Extract 07T_37792_04
16-022 Outer catheter Pebax 7233, braided Yes
Note A
with stainless steel
304, fluorinated ISO Intracutaneous NAMSA
ethylene propylene Study- Extract 07T_37792_05
lined. Bismuth 07T_37792_06
subcarbonate in Pebax
7233 tip
16-026 Bilumen tube Vestamid Yes
(inner
catheter)
28-125 Retention Nitinol Yes
wire
15-079 Retention Polytetrafluoroethyle Yes
wire ne
protection
21-077 Support Stainless steel 304 No
cannula
(inner
catheter)
10-146 Retention Stainless steel 304 No No Test Required No Test Required
wire cannula
loop
10-148 Introducer Stainless steel 304 No No Test Required No Test Required
support
cannula (inner
catheter)
10-150 Cannula Stainless Steel No No Test Required No Test Required
16-030 Outer catheter Pebax 7233, braided Yes ***Cytotoxicity NAMSA
Note B
with stainless steel (***PTF Study Using the ISO 09T_43167_03
Note C
304, PTFE lined. E Lining Elution Method
Bismuth is
subcarbonate in Indirect ***Biological Safety NAMSA
Pebax 7233 tip patient Assessment 08G_47519_01
Contact)
ISO Maximisation NAMSA
Sensitization Study- 07T_37792_03
Extract 07T_37792_04
Page 6 of 32
Contact
ISO Intracutaneous NAMSA

Study- Extract 07T_37792_05
07T_37792_06
28-172 PERT Distal Stainless Steel 304 Yes Cytotoxicity Study NAMSA
Note B
Collar Using the ISO 09T_43167_03
Note C
Elution Method
Biological Safety NAMSA

Assessment 08G_47519_01
®
Table 4.3: Evolution Esophageal Stent System: Introducer Materials.
Stent
The Stent part of the device is in the implant category, with permanent tissue contact
in the esophagus. EN ISO10993-1 recommends that a device with this level of contact
be tested for:
• Cytotoxicity
• Sensitization
• Acute Systemic Toxicity
• Subacute and Subchronic Toxicity
• Genotoxicity
• Implantation
EN ISO10993-1 also recommends that Chronic Toxicity and Carcinogenicity be

considered.
The testing was initially completed on the partially covered device (without the
UHMWPE lasso loop, Green PTFE and PTFE impregnated polyester lasso loop). The
biocompatibility for the lasso loops was assessed separately.
Genotoxicity was performed on the Evolution® Esophageal Stent System-Fully

Covered stent components: nitinol wire, silicone (stent covering), green PTFE and
UHMWPE). From the results of these tests these materials were considered non-
mutanagenic to the tester strains and they did not induce micronuclei in mice. Also, a
biological risk assessment and a chemical characterisation with risk assessment were
performed on the stent materials (NAMSA 07G_34442_01 and WuXi Apptec report
11-2594 Version 1 (BA11.009-GG)) which support that Genotoxicity is not a
significant risk.
Carcinogenicity was also not performed as there are no indications that any of the
materials used in the stent are carcinogenic.
Page 7 of 32
Chronic Toxicity testing was performed as part of the implantation testing and as an
FDA requirement. Implantation testing was merged with a 4 week Subchronic
Toxicity test and the 13 week Chronic Toxicity study to minimise the number of
animals tested.
For the biocompatibility testing performed on the Stent the Cytotoxicity testing
showed no evidence of cell lysis or toxicity and the Sensitisation testing showed no
delayed dermal contact sensitisation. For the Intracutaneous testing there was very
slight erythema and edema from the SO extract injected intracutaneously into rabbits
but the Stent still met the requirements of the test. There was no evidence of Acute
Systemic Toxicity. For the 4 week Implantation there was no evidence of systemic
toxicity, no significant local macroscopic tissue reaction compared to the control and
microscopically the test article was classified as a non-irritant compared to the control
article. For the 13 week Implantation there was no effect on hematologic and clinical
chemistry parameters.
The stent nitinol is cleaned as part of the manufacturing process. All manufacturing
at Cook takes place in a controlled environment where all permitted materials are
defined. The samples tested have all been processed through the Cook CMA so any
consumables or residues will have been accounted for during the biocompatibility
testing on the Evolution® Esophageal stent system.
The stent has been tested for corrosion under VAL07-0022. This validation exposed
Evolution Esophagael Stents to a Gastric and Saliva environment. No significant
corrosion was observed for the stent. The stability of the Stent materials help to
support a favourable biocompatibility status.
The nitinol in the stent is supplied by Fort Wayne Metals and is their grade NiTi#1.
The NiTi#1 grade of nitinol exceeds the requirements of ASTM F2063-05 Standard
Specification for Wrought Nickel-titanium Shape memory alloys for Medical Devices
and Surgical Implants. ASTM F2063-05 grade nitinol has been used in medical
implants since 1972.
Lasso Loops
Tevdek Green Polytetrafluorethylene (PTFE) Impregnated Polyester (Note A)

The Tevdek suture material has been tested for biocompatibility by Cook Urological
in accordance with the biocompatibility tests suggested by the table in EN ISO10993-
1. All this testing was successful and supports the use of the Tevdek suture as a suture
loop on the Evolution® Esophageal Stent partially covered. In the 4 and 13 week
Systemic Toxicity Tests the Tevdek material exhibited signs of being a slight irritant
under microscopic examination. In a 2 week ISO Muscle Implantation Study the
Tevdek was ranked as a moderate irritant under microscopic examination. Evidence
of slight to moderate microscopic irritation is gone by 26 as evidenced in the ISO
Muscle Implantation Study 26 week study. Macroscopically the Tevdek suture does
not appear to be an irritant in either the Systemic Toxicity Tests or the Implantation
tests. It can be seen that the microscopic irritation decreases over time after
implantation and eventually disappears. The irritation seen in these studies is a worse
Page 8 of 32
case where the Tevdek suture is directly implanted into tissue. In use with the
Evolution® Esophageal Stent partially covered the Tevdek suture will have surface
contact with tissue as a worst case. Considering that the irritation is at a microscopic
level only and that it disappears over time, all the other successful biocompatibility
data documented in TST10-023, it can be concluded that the Tevdek suture is fit for
its purpose as a suture on the Evolution® Esophageal Stent partially covered from a
biocompatibility perspective.
Ultra high molecular weight Polyethylene (UHMWPE)

Biocompatibility testing was carried out on this material in accordance with the
biocompatibility tests suggested by the table in EN ISO10993-1. This testing was
successful and supports the use of this material on the Evolution® Esophageal Stent
System (both partially and fully covered).
Green PTFE (Note C)

The Green PTFE material is used as part of the grasping feature in the Evolution®
Esophageal Stent System-Fully Covered (version 2). Biocompatibility testing was
carried out on this material in accordance with the biocompatibility tests suggested by
the table in EN ISO10993-1. This testing was successful and supports the use of this
material on the Evolution® Esophageal Stent System-Fully Covered (version 2).
See Table 4.4 for the Stent biocompatibility test summary.

Contact
25-403 Stent wire Nitinol wire Yes Cytotoxicity Study NAMSA
Using the ISO 07T_37792_02
Elution Method 07T_33449_02

Silicone Nusil silicone grade Yes Extract 07T_37792_04
N/A membrane MED-4755 07T_33449_03
07T_33449_04

07T_37792_06
07T_33449_05
10-145 Marker Tantalum Yes 07T_33449_06
Bands
Page 9 of 32
Contact
ISO Systemic NAMSA
Toxicity Study- 07T_33449_07
Four Week Systemic NAMSA

Toxicity Study in 07T_33449_09
Rats Following
Subcutaneous
Implant
Thirteen Week NAMSA

Systemic Toxicity 07T_33449_13
Study in Rats
Following
Subcutaneous
Implant
Genotoxicity- NAMSA
Bacterial Reverse 11T_56063_04
Mutation Study and
(95% Ethanol 11T_56063_05
Extract and Saline
Extract)
Genotoxicity- NAMSA
Mouse Peripheral 11T_56063_02
Blood Micronucleus and
Study 11T_56063_03
Genotoxicity: Mouse NAMSA

Lymphoma Assay 12T_34552_03
with a Dose Range
Finding Test
Biological Risk NAMSA

Assessment of the 07G_34442_01
SEMS device
(Silicone-coated
Esophageal Metal
Stent)
Chemical WuXi Apptec

Characterisation and report 11-2594
Risk Assessment Version 1
(BA11.009-GG)
20-081 Lasso loop Tevdek Green Yes Cytotoxicity Study NAMSA
Page 10 of 32
Contact
Note A Polytetrafluorethylene Using the ISO 08T_28881_01
Elution Method
(PTFE) Impregnated
Polyester ISO Maximisation NAMSA
Sensitization Study- 08T_28882-01 &
Extract 08T_28882-02
NAMSA
ISO Vaginal 08T_28871_01 &
Irritation Study 08T_28871_02
ISO Systemic NAMSA

Toxicity Study- 08T_28879_01 &
Genotoxicity-
NAMSA
Bacterial Reverse
08T_28869_02
Mutation Study
(95% Ethanol
Extract)
NAMSA
Genotoxicity-
08T_28869_01
Bacterial Reverse
Mutation Study
(Saline Extract)
NAMSA
Mouse Peripheral
08T_28883_01 &
Blood Micronucleus
08T_28883_02
Study
NAMSA
Genotoxicity: Mouse
08T_28870_01 &
Lymphoma Assay
08T_28870_02
4 Week Systemic
NAMSA
Toxicity Study in
08T_34181_01
Rats Following
Subcutaneous
Implant
13 Week Systemic
NAMSA
Toxicity Study in
08T_34175_01
Rats Following
Subcutaneous
Page 11 of 32
Contact
Implant
ISO Muscle
Implantation Study- NAMSA
2 Weeks 08T_29180_01
ISO Muscle
Implantation Study- NAMSA
26 Weeks 08T_29179_01
15-331 Lasso Loop- PTFE Green Yes Cytotoxicity Study NAMSA
Note C Grasping Using the ISO 11T_42871_02
Feature Elution Method

Extract and
11T_42871_06

and
11T_42871_08
ISO Systemic NAMSA

Toxicity Study- 11T_42871_03
Extract and
11T_42871_04
ISO Subcutaneous
Implantation Study NAMSA
in Rabbits - 2 week 11T_43789_05
implantation
4 Week Systemic NAMSA

Rats Following
Subcutaneous
Implant

Rats Following
Subcutaneous
Implant

Page 12 of 32
Contact
Rats Following
Subcutaneous
Implant
Genotoxicity-
Bacterial Reverse NAMSA
Mutation Study 11T_56063_04
(95% Ethanol and
Extract and Saline 11T_56063_05
Extract)
Genotoxicity-
Mouse Peripheral NAMSA
Blood Micronucleus 11T_56063_02
Study and
11T_56063_03
Genotoxicity: Mouse
Lymphoma Assay NAMSA
with a Dose Range 12T_34552_03
Finding Test
Chemical
Characterisation and WuXi Apptec
Risk Assessment report 11-2594
Version 1
(BA11.009-GG)
25-463 Lasso Loop Force Fibre Suture, Yes Cytotoxicity Study NAMSA
USP Size 0 White Using the ISO 11T_43564_01
Ultra high molecular Elution Method
weight Polyethylene
(UHMWPE) ISO Maximisation NAMSA
Extract and
11T_43564_05

and
11T_43564_07
ISO Systemic
NAMSA
Toxicity Study-
11T_43564_02
Extract
and
11T_43564_03
ISO Subcutaneous
NAMSA
Implantation Study
11T_43789_05
in Rabbits - 2 week
Page 13 of 32
Contact
implantation
4 Week Systemic
Toxicity Study in NAMSA
Rats Following 11T_56687_12
Subcutaneous
Implant
13 Week Systemic
Subcutaneous
Implant
26 Week Systemic
Subcutaneous
Implant
Genotoxicity-
Bacterial Reverse NAMSA
Mutation Study 11T_56063_04
(95% Ethanol and
Extract and Saline 11T_56063_05
Extract)
Genotoxicity-
Mouse Peripheral NAMSA
Blood Micronucleus 11T_56063_02
Study and
11T_56063_03
Genotoxicity: Mouse
Lymphoma Assay NAMSA
with a Dose Range 12T_34552_03
Finding Test
Chemical
Characterisation and
WuXi Apptec
Risk Assessment
report 11-2594
Version 1
(BA11.009-GG)
®
Table 4.4: Evolution Esophageal Stent System: Self Expanding Metal Stent Materials
Stent part numbers: Partially Covered: 12-439, 12-440, 12-442 & 12-442, Fully Covered:
(version 1)12-111, 12-112, 12-113, 12-292, 12-293 and 12-294, Fully Covered: (version 2) 12-
476, 12-477, 12-478, 12-479, 12-480 and 12-481
Page 14 of 32
Handle
Most of the non patient contact materials are contained within the handle as gears and
pulleys. These materials will have no patient or physician contact. The physician will
have contact with the outer shell of the handle, safety lock, rack trigger and direction
switch. All these components are made from polycarbonate type materials which will
not produce a residue that could transfer to a patient. There is no risk to
biocompatibility posed by the non-patient contact materials.
The female luerlock adaptor is indirect patient contacting and testing completed on
the Evolution® Colonic/Duodenal device includes this component.
See Table 4.5 for the Handle biocompatibility test summary.

Contact
28-098 Gear 1(left Acetal – DuPont No No Test Required No Test Required
drive gear) grade Delrin
500P NC010
28-099 Gear 2 (left Acetal – DuPont No No Test Required No Test Required
pulley gear) grade Delrin
500P NC010
28-100 Gear 3 (right Acetal – DuPont No No Test Required No Test Required
drive gear) grade Delrin
500P NC010
idler) grade Delrin
500P NC010
pulley gear) grade Delrin
500P NC010
28-103 Gear 6 Acetal – DuPont No No Test Required No Test Required
(trigger drive grade Delrin
gear) 500P NC010
28-104 Drive pulley Acetal – DuPont No No Test Required No Test Required
grade Delrin
500P NC010
28-105 Belt pulleys Acetal – DuPont No No Test Required No Test Required
(front and grade Delrin
back) 500P NC010
28-107 Idle roller Acetal – DuPont No No Test Required No Test Required
cam grade Delrin
500P NC010
28-108 Shuttle Polycarbonate No No Test Required No Test Required
grade Lexan
241R
28-109 Shuttle Cap Polycarbonate No No Test Required No Test Required
80 grade Lexan
Page 15 of 32
Contact
241R
28-111 Rack trigger Polycarbonate No No Test Required No Test Required
grade Lexan
241R
28-112 Direction Polycarbonate No No Test Required No Test Required
switch grade Lexan
241R
28-114 FLLA socket Lupilon No No Test Required No Test Required
GSH2010R2
(10% glass-filled
polycarbonate)
25-067 Adapter – Polycarbonate Indirect Cytotoxicity Study NAMSA
female (80130) Using the ISO 08T_21166_02
luerlock Elution Method
NAMSA
ISO Maximisation 08T_21166_05
Extract
NAMSA
ISO Intracutaneous 08T_21166_03
28-117 Spring - post Polycarbonate No No Test Required No Test Required
Grade Lexan
241R
28-119 Handle outer PC / ABS No No Test Required No Test Required
shell left (Polycarbonate /
Acrylonitrile
butadiene
styrene blend)
grade cycology
C2950
28-120 Handle outer PC / ABS No No Test Required No Test Required
shell right (Polycarbonate /
Acrylonitrile
butadiene
styrene blend)
grade cycology
C2950
28-118 Safety-lock Polycarbonate No No Test Required No Test Required
Grade Lexan
241R
30-330 SEMS Stainless Steel No No Test Required No Test Required
Compression with PTFE
spring coating
28-154 Optibelt drive Polychloropren/gl No No Test Required No Test Required
belt 250 XL asscord/
025 polyamide
Page 16 of 32
Contact
28-124 Drive pulley Stainless steel No No Test Required No Test Required
shaft 304
28-122 Drive gear Stainless steel No No Test Required No Test Required
shaft 316
28-123 Idler pin Stainless steel No No Test Required No Test Required
304
28-144 Drive pulley Aluminium No No Test Required No Test Required
fix
90-242, Point of no FASSON PE 85 No No Test Required No Test Required
90-243, return label TOP White /
90-244 Partially S692N / BG40
or Covered white
90-245
Note A
90-274 Point of no FASSON PE 85 No No Test Required No Test Required
90-276 return label TOP White/
90-278 Fully S692N / BG40
90-312 Covered white
90-314
90-316
Note B
90-374 Point of no FASSON PE 85 No No Test Required No Test Required
90-376 return label TOP White/
90-378 Fully S692N / BG40
90-380 Covered white
90-382
90-384
Note C
Table 4.5: Evolution® Esophageal Stent System: Handle Materials.
Consumables
The consumables used in the manufacture of Evolution® Esophageal Stent System are
a silicone fluid used as a lubricant on the stent, solvent and nusil primer used during
stent manufacture, and Loctite adhesives and a Loctite primer used in the introducer
section. The solvent used is toluene and is used to mix silicone during the coating of
the stent. The toluene is evaporated off during the stent curing process which is 200C
for 30 minutes. The sutures listed in table 4.6 are used for stent loading and are not
part of the finished device.
The biocompatibility testing on the consumables used in the manufacture of the

Evolution® Esophageal Stent System is summarised in Table 4.6. The test results are
discussed in the Introducer and Stent sections.
Page 17 of 32
Contact
25-409 Silicone Lubricant Yes Biological Risk NAMSA
Fluid MED- Assessment of 07G_34442_01
400 the SEMS
device (Silicone-
coated
Esophageal
Metal Stent)
25-066 Loctite 4061 Adhesive Yes Refer to table 4.3 for biocompatibility
35-001 Loctite Adhesive Yes testing of the Evolution® Esophageal
20268 Stent System Introducer Materials.
/26073/
4013
37-036 Loctite 7701 Primer Yes
25- Solvent Toluene No Reference table for biocompatibility
4025 testing of the Esophageal stent.
N/A Nusil MED6-161 Yes
Primer
N/A Suture 3.0 WHITE TEVDEK No No Test No Test Required
Note B thread 3.0 (1110-TW). Required
white
Tevdek
20-081 Suture Tevdek Green 1113-T No No Test No Test Required
Note A Polytetrafluorethylene Required
Note C
(PTFE) Impregnated
Polyester
®
Table 4.6: Evolution Esophageal Stent System: Consumables
Selection of Devices for Biocompatibility Testing

All the products in the Evolution® Esophageal Stent System range share common
materials (with the differences as outlined above). Testing was carried out on the
EVO-20-25-15-E product in order to get biocompatibility data on the common stent
and introducer materials across the Evolution Esophageal product range. This was
used to represent the introducer and the stent for Cytotoxicity, Sensitization and
Irritation or Intracutaneous testing. The following stents Part 12-034 and 12-035 were
chosen to represent all the stent only biocompatibility testing. The FLLA (RMN 25-
067) is common to the Evolution® Colonic/Duodenal products and testing on these
products included this component.
Additional biocompatibility data/ information on the materials are used to substantiate
where there were changes to materials. Additional testing was carried out where
required for design changes where new materials were introduced and also tested for
the new requirements for benign indication (e.g. genotoxicity). This testing was
carried out on hybrid devices/stents, which incorporated the new materials from the
design change.
Page 18 of 32
Conclusion:
The Evolution® Esophageal Stent System meets the requirements of EN ISO10993-1

based on the biocompatibility testing conducted, the knowledge of the manufacturing
materials and the controlled manufacturing processes.
The biocompatibility of the Evolution® Esophageal Stent System is substantiated by

the testing outlined in TST08-002, TST09-062, TST10-023, TST08-083, TST08-037
and BA11.010-A. The testing carried out under BA11.010-A includes the following:
BA11.010-F, BA11.010-I, BA11.010-G, BA11.010-H, BA11.010-K, BA11.009-K,
BA11.009-Q, BA11.009-M, BA11.009-O, BA11.009-V, BA11.009-Y, BA11.009-W,
BA11.009-X, BA11.009-CC, BA11.009-EE and BA11.009-GG.
All the test reports and biocompatibility reports are filed in Document Control or in
regulatory affairs.
Page 19 of 32
4.4.2 The Evolution® Duodenal / Colonic Stent System
The intended use for the Evolution® Duodenal and Colonic stent systems is outlined
in section 3.2.
Evolution® Duodenal/Colonic Stent System has two types of body contact according
to ISO10993-1. The two different types of body contact are experienced by the
Introducer and the Stent components of the Evolution® Duodenal/Colonic Stent
System.
Introducer
The Introducer section is an externally communicating device with tissue contact for a
limited duration. The patient contact for the introducer is likely to be less than one
hour. By ISO10993-1 a device with contact duration of <24 hours there is a
recommendation for the following tests:
• Cytotoxicity
• Sensitization
All the testing recommended by ISO10993-1 was performed on the Introducer. The
Cytotoxicity testing on the introducer showed no evidence of cell lysis or toxicity.
The Sensitisation testing showed no delayed dermal contact sensitisation in the guinea
pig. For the Intracutaneous testing there was no erythema and no edema from the SC
extract injected intracutaneously into rabbits. There was very slight erythema and
edema from the SO extract but the Introducer still met the requirements of the test
since the difference between the test extracts and corresponding control mean score
was less than 1.0.
The above testing was repeated for the outer catheter version 2. The cytotoxicity
testing showed no evidence of the test article causing cell lysis or toxicity and the
Sensitisation testing showed no delayed dermal contact sensitisation. For the
Intracutaneous testing there was very slight erythema and edema from the SO extract
injected intracutaneously into rabbits but the outer catheter still met the requirements
of the test.
See Table 4.7 for the Introducer biocompatibility test summary.

Contact
28-095 Introducer Pebax 3533 Yes
system tip with 40%
(inner barium
catheter) Cytotoxicity Study NAMSA
10-141 Polyimide Braided Yes Using the ISO 08T_21166_02
Tubing Polyimide with Elution Method
(Inner 304V SS @ 80
Catheter) PIC
15-266 Introducer Tantalum Yes
Page 20 of 32
Contact
Marker
Bands (Inner
Catheter) NAMSA
18-123 Inner: Nylon Yes ISO Maximisation 08T_21166_05
Introducer with Bismuth, Sensitization 08T_21166_06
Pusher Outer: Nylon Study-Extract
(Inner with colourant
Catheter) added
16-024 Introducer Annealed Yes
PEEK PEEK
Tubing
(Inner NAMSA
Catheter) ISO Intracutaneous 08T_21166_03
16-023 Introducer PTFE Yes Study- Extract 08T_21166_04
PTFE
Tubing
(Inner
Catheter)
16-025 Retrieval Stainless Steel Yes
Loop (Inner ASTM 302 /
Catheter) 304
28-141 Nitinol Nitinol Wire Yes
Retention
wire
15-279 Tubing Tantalum Indirect
18-359, Outer PTFE lining, Yes Cytotoxicity Study 15T_67103_04
18-360 Catheter Nylon Outer Using the ISO (BA12.028-E)
and surface (Clear Elution Method
18-361 distal section is
a Pebax/Nylon ISO Guinea Pig 15T_67103_07 and
Copolymer), Maximisation 15T_67103_08
Braid: Stainless Sensitization Study (BA12.028-G)
Steel 304V
Coil: Stainless ISO Intracutaneous 15T_67103_05 and
Steel 304V Study in rabbits 15T_67103_06
(BA12.028-F)
21-078 Introducer Stainless Steel No No Test Required No Test Required
support ANSI 304
cannula
(Inner
Catheter)
18-107 Introducer Nylon-12 No No Test Required No Test Required
Nylon Natural
Tubing
(Inner
Catheter)
10-146 Cannula Stainless Steel No No Test Required No Test Required
Page 21 of 32
Contact
304
®
Table 4.7: Evolution Duodenal/Colonic Stent System: Introducer Materials.
Stent
The Stent part of the device is in the implant category, with permanent tissue contact
in the duodenum or colon. ISO10993-1 recommends that a device with this level of
contact be tested for:
• Cytotoxicity
• Sensitization
• Acute Systemic Toxicity
• Subacute and Subchronic Toxicity
• Genotoxicity
• Implantation
ISO10993-1 also recommends that Chronic Toxicity and Carcinogenicity be

considered.
For the Stent, Genotoxicity was not performed. From a biological risk assessment
performed on the stent materials (NAMSA 07G_34442_01) Genotoxicity is not a
significant risk. Carcinogenicity was also not performed as there are no indications
that any of the materials used in the stent are carcinogenic.
The testing of the Evolution® Esophageal Stent was used to substantiate the
biocompatibility of the Evolution® Duodenal/Colonic Stent as all the materials in the
Evolution® Duodenal/Colonic Stent are also present in the Evolution® Esophageal
Stent. The results of this testing are described in the Evolution® Esophageal Stent
section and the test numbers are referenced here.
The stent nitinol is cleaned as part of the manufacturing process. All manufacturing
at Cook takes place in a controlled environment where all permitted materials are
defined. The samples tested have all been processed through the Cook CMA so any
consumables or residues will have been accounted for during the biocompatibility
testing on the Evolution® Esophageal stent system.
The stent has been tested for corrosion under VAL07-0015. This validation exposed
Nitinol Enteral and Colonic Stents to a Gastric, Bile and Pancreatic fluids. No
significant corrosion was observed for the stent. The stability of the Stent materials
help to support a favourable biocompatibility status.
The nitinol in the stent is supplied by Fort Wayne Metals and is their grade NiTi#1.
The NiTi#1 grade of nitinol exceeds the requirements of ASTM F2063-05 Standard
Specification for Wrought Nickel-titanium Shape memory alloys for Medical Devices
Page 22 of 32
and Surgical Implants. ASTM F2063-05 grade nitinol has been used in medical
implants since 1972.
See Table 4.8 for the Stent biocompatibility test summary.

Contact
25-402 Stent wire Nitinol Yes Cytotoxicity Study Using NAMSA
wire the ISO Elution Method 07T_37792_02
07T_33449_02
08T_21166_02

07T_33449_03
07T_33449_04
08T_21166_05
08T_21166_06

07T_37792_06
07T_33449_05
10-145 Marker Bands Tantalum Yes 07T_33449_06
08T_21166_03
08T_21166_04
ISO Systemic Toxicity NAMSA

N/A Silicone Nusil Yes 07T_33449_08
Silicone
Grade Four Week Systemic NAMSA
MED- Toxicity Study in Rats 07T_33449_09
4755 Following Subcutaneous
Implant
Thirteen Week Systemic NAMSA

Toxicity Study in Rats 07T_33449_13
Following Subcutaneous
Implant
Biological Risk NAMSA

Assessment of the SEMS 07G_34442_01
device (Silicone-coated
Esophageal Metal Stent)
Page 23 of 32
Table 4.8: Evolution® Duodenal/Colonic Stent System: Self Expanding Metal Stent
Handle
Most of the non patient contact materials are contained within the handle as gears and
pulleys. These materials will have no patient or physician contact. The physician will
have contact with the outer shell of the handle, safety lock, rack trigger and direction
switch. All these components are made from polycarbonate type materials which will
not produce a residue that could transfer to a patient. There is no risk to
biocompatibility posed by the non-patient contact materials. The female luerlock
adaptor was tested as part of the introducer and the results are discussed there.
See Table 4.9 for the Handle biocompatibility test summary.

Contact
28-098 Gear 1(left Acetal – No No Test Required No Test Required
drive gear) DuPont grade
Delrin 500P
NC010
28-099 Gear 2 (left Acetal – No No Test Required No Test Required
pulley gear) DuPont grade
Delrin 500P
NC010
28-100 Gear 3 (right Acetal – No No Test Required No Test Required
drive gear) DuPont grade
Delrin 500P
NC010
idler) DuPont grade
Delrin 500P
NC010
pulley gear) DuPont grade
Delrin 500P
NC010
28-103 Gear 6 Acetal – No No Test Required No Test Required
(trigger drive DuPont grade
gear) Delrin 500P
NC010
28-104 Drive pulley Acetal – No No Test Required No Test Required
DuPont grade
Delrin 500P
NC010
28-105 Belt pulleys Acetal – No No Test Required No Test Required
(front and DuPont grade
back) Delrin 500P
NC010
Page 24 of 32
Contact
28-107 Cam roller Acetal – No No Test Required No Test Required
DuPont grade
Delrin 500P
NC010
28-108 Shuttle Polycarbonate No No Test Required No Test Required
grade Lexan
241R
28-110 Shuttle-Cap- Lupilon No No Test Required No Test Required
34 GSH2010R2
(10% glass-
filled
polycarbonate)
28-111 Rack trigger Polycarbonate No No Test Required No Test Required

grade Lexan
241R
28-112 Direction Polycarbonate No No Test Required No Test Required
switch grade Lexan
241R
28-113 Nozzle-34 PolyCarbonate No No Test Required No Test Required
GE Plastics
Grade Lexan
241R
25-067 Adapter – Polycarbonate Indirect Cytotoxicity Study NAMSA
female (80130) Using the ISO Elution 08T_21166_02
luerlock Method
NAMSA
Extract
NAMSA
28-114 FLLA socket Lupilon No No Test Required No Test Required

GSH2010R2
(10% glass-
filled
polycarbonate)
28-117 Spring - post Polycarbonate No No Test Required No Test Required

Grade Lexan
241R
28-146 TTS Outer PC/ABS No No Test Required No Test Required
Shell Left (Polycarbonate
/Acrylonitrile
butadiene
Page 25 of 32
Contact
styrene blend)
GE Plastics
Grade
Cycology
C2950
28-147 TTS Outer PC/ABS No No Test Required No Test Required
Shell Right (Polycarbonate
/Acrylonitrile
butadiene
styrene blend)
GE Plastics
Grade
Cycology
C2950
28-118 Safety-lock Polycarbonate No No Test Required No Test Required
Grade Lexan
241R
30-330 SEMS Stainless Steel No No Test Required No Test Required
Compression with PTFE
spring coating
28-155 Optibelt Polychloropren/ No No Test Required No Test Required
Drive Belt glasscord/
316XL 025 polyamide
77ST
28-124 Pulley shaft Stainless steel No No Test Required No Test Required
304
28-122 Gear shaft Stainless steel No No Test Required No Test Required
316
28-123 Idler pin Stainless steel No No Test Required No Test Required
304
28-144 Drive pulley Aluminium No No Test Required No Test Required
fix
90-246 No Return FASSON PE No No Test Required No Test Required
90-247 Label 85 TOP White
90-248 / S692N /
90-249 BG40 white
90-250
90-251
Table 4.9: Evolution® Duodenal/Colonic Stent System: Handle Materials.
Consumables
The consumables used in the manufacture of Evolution® Duodenal/Colonic Stent
System are Loctite adhesives The biocompatibility testing on the consumables used in
the manufacture of the Evolution® Duodenal/Colonic Stent System is summarised in
Table 4.10. The test results are discussed in the Introducer and Stent sections.
Page 26 of 32
Contact
25-066 Loctite 4061 Adhesive Yes Cytotoxicity Study NAMSA
Using the ISO Elution 07T_37792_02
Method
NAMSA
Extract
NAMSA
35-001 Loctite Adhesive No No Test Required No Test Required

20268
/26073/
4013
N/A Permabond Adhesive No No Test Required No Test Required

820
Dymax UV (Manufacturing
aids in outer
catheter version
2)
Table 4.10: Evolution® Duodenal/Colonic Stent System: Consumables
Selection of Devices for Biocompatibility Testing

All the products in the Evolution® Duodenal/Colonic Stent System range use the same
materials so which ever stent and introducer was chosen, all the products in the range
would be represented. EVO-25-30-10-C was used to represent the introducer and the
stent for Cytotoxicity, Sensitization and Irritation or Intracutaneous testing. Part 12-
034 and 12-035 from the Evolution® Esophageal Stent System were chosen to
represent all the stent only biocompatibility testing. Testing on EVO-20-25-15-E was
referenced for additional supporting information for cytotoxicity, sensitization and
intracutaneous testing.
Conclusion:
The Evolution® Duodenal/Colonic Stent System meets the requirements of

ISO10993-1 based on the biocompatibility testing conducted, the knowledge of the
manufacturing materials and the controlled manufacturing processes.
All biocompatibility testing for the Evolution® Duodenal/Colonic Stent System is

documented in BA12.028-A. Test reports are filed in Document Control. .
Page 27 of 32
4.5 Sterility
Cook Ireland sterilise Evolution® Esophageal / Duodenal / Colonic Stent System at

Synergy Health Ireland Limited, in Tullamore, County Offaly. The sterilisation
method is by Ethylene Oxide (EO) using a sterilisation cycle validated in accordance
with EN ISO 11135 “ Sterilization of healthcare products - Ethylene oxide:
Requirements for the development, Validation and routine control of a sterilization
process for medical devices.”.
Synergy Health Ireland Limited is 11135 certified and perform the sterilisation of
Cook Ireland products on a validated line at their facility.
In order to sterilise products in this technical file; they have been validated to a
Sterility Assurance Level of 10-6. For details of the Product Sterilisation Report and
other supporting information, see the Sterilisation Review located in Appendix G.
Details on Residual Information are also contained in Appendix G.
EO Residue complies with EN ISO 10993-7 (Biological evaluation of medical

devices Part 7: Ethylene oxide sterilization residuals). Residue testing is documented
in in the following table.
Bioburden levels are monitored and controlled as per D00059708 (QSI0924).

Bioburden validation and testing for the Evolution® product range are documented in
the following table.
Product Residue Bioburden
Evolution® Esophageal Duodenal/Colonic TST08-038 TST08-038

Stent System. TST16-061 TST16-062
Evolution® Partially Covered Esophageal TST10-044 TST08-003,
Stent System TST09-059
TST10-024
Evolution® Esophageal Stent System Fully TST09-059 TST09-059
Covered (version1)
Evolution® Esophageal Stent System Fully TST11-029 TST11-029
Covered (version 2)
Table 4.11: Evolution® residual and bioburden test report numbers.
Sterilisation validation records are maintained by the Document Control Department.
Page 28 of 32
4.6 Packaging
The product is placed in a tray with protective tubing over the the distal end of the
product. There is a tray lid placed over the handle part of the product. The product in
the tray is then double pouched, each pouch being individually sealed. For the
Evolution® Esophageal products the inner pouch after being sealed is folded down at
one end and held in place with a clear label. After pouching the product is placed in a
box. Reference the following tables for details of the packaging materials.
Product Code Packaging RM Material Material

Component Number Specification
(CPN)
EVO-20-25-(X)X-E, Stent 18-125 PPNT (Polypropylene) RMS0044
EVO-20-25-XX.X-E Protective
EVO-FC-(R)XX-XX-(X)X-E
Tubing
Packaging 20-118 GPET (Polyethylene DWG0349
Tray terephthalate)
Packaging 20-117 GPET (Polyethylene DWG0350
Tray Lid terephthalate)
Inner Pouch 26-007 PET/PE film: 35890-G or DWG0009
equivalent grade 12/50,
Outer Pouch 26-008 PET/PE film: 35890-G or DWG0009
equivalent grade 12/50
,Mylar, Tyvek 1073B CR27
Clear label 90-403 Clear label HC0410085-001 N/A
EVO-20-25-(X)X-E, Product Box 95-104 E Flute Cardboard CHT0037
EVO-20-25-XX.X-E
EVO-FC-XX-XX-(X)X-E Product Box 95-112 E-Flute Cardboard CHT0037

EVO-FC-R-XX-XX-(X)X-E Product Box 95-164 E-Flute Cardboard CHT0037
EVO-FC-R-XX-XX-(X)X-E Label 90-406 MCPrime with permanent RMS0195
S2045N adhesive
Table 4.12: Evolution® Esophageal Stent System: Packaging Materials
Product Code Packaging RM Material Material

Component Number Specification
(CPN)
EVO-XX-XX-(X)X-C, Stent 18-124 PPNT (Polypropylene) RMS0044
EVO-XX-XX-(X)X-D Protective
Tubing
Packaging 20-116 PETG (Polyethylene DWG0348
Tray Terephthalate Glycol)
Packaging 20-120 PETG (Polyethylene DWG0481
Tray Lid Terephthalate Glycol)
Page 29 of 32
Inner Pouch 26-005 PET/PE film: 35890-G or DWG0009
equivalent grade 12/50,
Outer Pouch 26-006 PET/PE film: 35890-G or DWG0009
equivalent grade 12/50
EVO-XX-XX-(X)X-C Product Box 95-103 E Flute Cardboard CHT0037
EVO-XX-XX-(X)X-D Product Box 95-106 E Flute Cardboard CHT0037
Table 4.13: Evolution® Colonic and Duodenal Stent Systems: Packaging Materials
Product Packaging Testing:

Burst Testing is performed at the start and end of each shift as per SOP0901
(Operation of the Burst Tester (Automated Test-A-Pack System).
Packaging is supplied by qualified vendors and is inspected at incoming inspection.
These products are packaged in accordance with the following procedures:
Evolution® Esophageal Stent System- Partially Covered:

PKG0085 Pouching SEMS Esophageal products
PKG0086 Boxing of SEMS products.
Evolution® Esophageal Stent System- Fully Covered:

PKG0107 Pouching Evolution Esophageal Fully Coated Product
PKG0108 Boxing of Evolution Fully Covered Product
Evolution® Colonic Stent System and the Evolution® Duodenal Stent System:
PKG0090 Pouching Instruction for Duodenal/Colonic Stent Products
PKG0091 Boxing instruction for Duodenal/Colonic Stent Products
Product Packaging Validation:

Operational Qualification VAL0088 Re-validation of Cook Ireland Pouch Packaging
containing 12/50 PET/PE film.
Process Qualification VAL0089 Re-validation of Cook Ireland Pouch Packaging
containing 12/50 PET/PE film.
VAL07-0011 outlines the transportation and packaging integrity testing (including

aging) for Evolution® Esophageal Stent System. This is summarised in section 4.3.
This is applicable for the Esophageal fully covered and partially covered products.
Page 30 of 32
VAL07-0016 PPQ reviewed packaging post shipment and VAL08-0024 PQ of the
sealing of the Evolution® Duodenal / Colonic Stent System pouches. These test
reports are located in document control.
Note the packaging of the Evolution® Duodenal/Colonic System is substantially
equivalent to the packaging of the Evolution® Esophageal system which has been
subject to distribution simulation/Conditioning testing as per VAL07-0011.
Product Packaging validation records are maintained by the Document Control

Department.
4.7 Shelf Life
The “use by” date as denoted by EN 980 symbols on the labelling. The shelf life is
indicated on the label as the amount of time from the date of manufacture (factory
symbol) to the stated expiration date (hourglass symbol). The Evolution® product
range has a two (2) year shelf life.
Shelf life for the Evolution® Esophageal Stent System (Partially and Fully Covered) is
supported by packaging integrity testing (VAL07-0011) and design verification
testing (VAL07-0033) post 25 month real time aging and design verification testing
post transportation and 25 month accelerated aging carried out as per VAL07-0012
(VAL07-0012 applicable to non- stent components only). In addition to support the
shelf life for the Evolution® Esophageal Stent System shelf life testing was performed
on the lasso loop (TST09-041, TST09-074, VAL10-0033 and VAL10-0034).
Shelf life for the Evolution® Duodenal / Colonic Stent System is supported by Design
Verification and Validation Testing (VAL08-0049) post 25 months real time aging
and TST16-040 aging rationale for aging of outer sheath (Version 2 per DWG1879).
As the packaging is substantially equivalent to the packaging of the Evolution®
Esophageal system VAL07-0011 can also be used to support the shelf life of the
Evolution® Duodenal / Colonic Stent System.
4.8 Clinical Evidence

The Clinical Evaluation/Clinical Evidence Reports, based on a compilation of
relevant literature, concluded that the clinical benefits outweigh the risks associated
with Esophageal, Colonic and Duodenal stenting.
Reference Appendix F for the Clinical Evaluation/Clinical Evidence Reports.
Page 31 of 32
________________________________ ______________________
Regulatory Affairs Date
Page 32 of 32
TRADUCCIÓN SIMPLE
Sección 4.0
Resumen de los documentos de validación y verificación del diseño
Stents/Sets Metálicos
ITF049-MSS
4.1 Resumen de los documentos de validación y verificación del diseño
4.2 General
Las pruebas de validación y verificación del diseño para los productos cubiertos por este
expediente técnico se describen en las secciones siguientes (secciones 4.2 a 4.8). Estas
pruebas respaldan el rendimiento y la seguridad de estos productos según los requisitos
esenciales para su uso previsto (Apéndice D).
4.3 Plan de pruebas

El plan general de los productos se desarrolló a través del proceso de desarrollo de productos
de COOK Ireland D00059388 (QSP0400). La documentación de Design Control se
mantiene dentro del archivo de historial de diseño por el departamento de desarrollo de
productos.
Las pruebas de validación y verificación del diseño fueron realizadas y/o coordinadas por
COOK Ireland. Consulte las secciones 4.3 a 4.8 para obtener una visión general de las
pruebas realizadas y la información de apoyo.
La validación del proceso se examinó según la validación del proceso D00059428

(QSP0940). El plan maestro de validación de fabricación está documentado según
D00060554 (CHT0053) y D00060574 (CHT0204). El informe de validación del maestro
de fabricación está documentado según D00060555 (CHT0054).
Las especificaciones del producto son desarrolladas y verificadas por COOK Ireland. Las
instrucciones de fabricación de los productos se publican a través de los métodos de control
de documentos de Cook Ireland. Cualquier cambio, que pueda ocurrir en las instrucciones
y el diseño, se procesará a través de los métodos de control de cambios de Cook Ireland
según D00059381 (QSP0200) Desviación del control de cambios y según el procedimiento
de control de diseño D00059388 (QSP0400).
Los procedimientos actuales de fabricación y control de calidad requieren una inspección

de estos dispositivos, según las instrucciones documentadas pertinentes por parte de
personal capacitado para garantizar que los dispositivos cumplan con el producto. requisitos
de especificación antes del lanzamiento a la distribución. Los procedimientos actuales de
control del sistema de producción están diseñados para eliminar el potencial de errores y
defectos que podrían afectar la seguridad, el rendimiento y la integridad de estos
dispositivos. Un diagrama de flujo del sistema de producción se encuentra en el Apéndice
E.
4.4 Pruebas de laboratorio

Las pruebas de laboratorio para el Sistema de Stent Esofágico Evolution
parcialmente cubierto y totalmente cubierto comparten muchas de las mismas
pruebas que se muestran en la siguiente tabla:
Número de validación Descripción de las pruebas Parcialm Totalmen Totalmen

ente te te
cubierto cubierto cubierto
Versión 1 Versión 2
VAL07-0013 Rev 0 Pruebas de fuerza articular, √ √ √
dimensional y de uso simulado
.
VAL07-0014 Rev 0 Pruebas de implementación. √ √ √

TST07-038
VAL07-0022 Rev 0 Pruebas de corrosión. √ √ √
VAL07-0027 Rev 0 Pruebas automatizadas de fuerza √
radial.
VAL07-0067 Rev 0 Prueba de fatiga de eslinga radial. √
VAL07-0066 Rev 0 PPQ y verificación de diseño de √ √ √
manejo.
*TST08-085 Pruebas de componentes de mango . √ √ √
*VAL08-0058 Rev 0 Pruebas de verificación de diseño del √ √ √
mango
Componentes.
*VAL08-0020 Rev 0 Validación del bloqueo de rosca de √ √
FLLA
puerto y torquing FLLA joint.
TST10-103 Verificación del recubrimiento parcial √
del stent.
*VAL07-0011 Rev 0 Integridad del transporte y embalaje √ √ √
pruebas, pruebas de edad.
VAL07-0012 Rev 0 Pruebas post envejecimiento – √ √ √
introductor.
VAL07-0033 Rev 0 Pruebas de verificación de diseño √ √ √
post envejecimiento
VAL08-0042 Rev 0 Pruebas automatizadas de fuerza √
radial.
VAL09-0012 Rev 0 Pruebas de precisión de √ √
implementación y
pruebas dimensionales.
VAL09-0020 Rev 0 Implementación : pruebas de uso √
simuladas .
VAL09-0058 Rev 0 Pruebas de uso simulado – √
Modificado
Diseño de lazo de lazo de lazo.
TST09-033 Resistencia a la corrosión del ultra √ √
alto
lazo de polietileno de peso molecular.
TST09-073 Resistencia a la corrosión del lazo √
de lazo de lazo de poliéster
impregnado de PTFE.
VAL10-0070 Rev 0 Pruebas de corrosión : lazos de lazo √

de lazo
Número de validación Descripción de las pruebas Parcial Totalme Totalme
mente nte nte
(Exposición representativa de 10
semanas )
Pruebas de corrosión : lazos de lazo √
VAL10-0071 Rev 0 de lazo
semanas )
Pruebas de corrosión: Membrana de √
VAL11-022 Rev 0 stent
semanas )
Pruebas de tracción de lazos de √
VAL10-0074 Rev 0 lazo de lazo – post corrosión
(representativo 10 semanas).
Pruebas de tracción de bucles de lazos √

VAL10-0075 Rev 0 de lazo – poste
corrosión (representativa de 52
semanas).
VAL10-0079 Rev 0 Pruebas de tracción de los bucles de √
lazos de lazo.
Pruebas de tracción de bucles de √
VAL11-0021 Rev 0 lazos de lazo después de 52
semanas de prueba de fatiga.
VAL09-0055 Rev 0 Inspección visual y resistencia a la √ √

tracción
prueba del material del lazo de lazo
de lazo.
TST08-052 Compatibilidad con resonancia √ √ √
magnética .
TST09-041 Prueba de edad acelerada del √ √
material del lazo de lazo
(UHMWPE).
TST09-074 Envejecimiento acelerado PTFE √

lazo de lazo de lazo de poliéster
impregnado .
VAL10-0033 Rev 0 Pruebas de edad acelerada : bucles de √
lazo.
VAL10-0034 Rev 0 Pruebas de tracción : bucles de √
lazos de lazo después del
envejecimiento.
VAL08-0043 Rev 0 Prueba de fatiga de eslinga radial. √ √

VAL10-0077 Rev 0 Prueba de fatiga de eslinga radial. √
VAL11-0001 Rev 0 Pruebas de funcionalidad. √
Pruebas de funcionalidad : √
VAL11-0019 Rev 0 implementación
y la recuperación de la fuerza.
Comparación de las pruebas de √
VAL11-0020 Rev 0 fuerza radial
frente a dispositivos predicados.
Medición de las dimensiones del √
VAL11-0023 Rev 0 stent después del despliegue,
verificación de etiquetas.
Evaluación del desempeño versus √

VAL11-0024 Rev 0 dispositivos predicados.
*TST11-066 Para verificar la dimensión FLLA √ √ √
Número de validación Descripción de las pruebas Parcialm Totalmen Totalmen
ente te te
Requisitos.
*TST12-053 Verificación del etiquetado después √ √ √
de la crianza.
Tabla 4.1: Evolución de la matriz de pruebas esofágicas
* El sistema de stent duodenal/colónico Evolution® comparte algunas de las características

de diseño del sistema de stent esofágico Evolution . Los informes resaltados anteriormente
con un "*" también son aplicables al Sistema de Stent Colónico / Duodenal Evolution ®.
Los informes destacados en la Tabla 4.2 como ** indican pruebas específicas para el catéter
externo- versión 2 (IRE0045-K).
Un resumen de cada uno de los informes de verificación y validación del diseño enumerados en
los cuadros 4.1 y
4.2 se incluyen en el Apéndice I. El archivo de historial de diseño documenta las pruebas aplicables.
Número de validación Descripción de las pruebas Duodenal Colónico

VAL07-0016 Rev 0 Pruebas de despliegue, pruebas dimensionales de √ √
stent,
pruebas de resistencia a la tracción
VAL08-0011 Rev 0 Pruebas de implementación en una clínica simulada √ √
medio ambiente.
VAL08-0070 Rev 0 Pruebas de precisión de implementación. √ √
VAL07-0028 Rev 0 Pruebas automatizadas de fuerza radial. √ √
VAL07-0075 Rev 0 Prueba de fatiga radial de cabestrillo. √ √
VAL07-0015 Rev 0 Pruebas de corrosión por inmersión. √ √
TST08-043 Fuerza de retención del bucle de recuperación . √ √
VAL08-0018 Rev 0 Validación del Torquing y pegado del Shuttle √ √
Ninguno.
VAL08-0049 Rev 0 Pruebas de edad en tiempo real. √ √
TST11-067 Pruebas de resonancia magnética - Colónica. √
TST10-053 Pruebas de resonancia magnética - Duodenal. √
VAL08-0024 Rev 0 Proceso de sellado de bolsas √ √
NCT16-0036-R ** Pruebas de uso simulado – Catéter externo versión √ √
2.
NCT16-0079-R ** Pruebas de resistencia a la tracción – Catéter √ √
externo versión 2
Tabla 4.2: Evolución de la matriz de pruebas duodenales/colónicas
4.5 Biocompatibilidad
4.4.1 El sistema de stent esofágico Evolution®

Nota: Se hace referencia a los estándares según los protocolos de prueba. El
cumplimiento solo se reclama para las normas a las que se hace referencia en el
Apéndice H.
El uso previsto para los sistemas de stent esofágico Evolution® se describe en la

sección 3.2.
Evolution® Esophageal Stent System tiene dos tipos de contacto corporal según EN
ISO10993-1. Los dos tipos diferentes de contacto corporal son experimentados por
los componentes Introductor y Stent del Sistema Esofágico Evolution®.
Tanto el Evolution® Esophageal Stent System-Parcialmente Cubierto como el

Evolution® Esophageal Stent System-Fully Covered comparten la mayoría de sus
materias primas. A menos que se indique lo contrario, las materias primas enumeradas
en las tablas a continuación son comunes en todo el rango evolution® esofágico.
Donde aparece "Nota A" junto a un número RMN, esto indica que el material se utiliza
en el sistema de stent esofágico Evolution-Parcialmente® cubierto. Donde aparece
"Nota B" junto a un número RMN, esto indica que el material se utiliza en la versión
1 de Evolution® Esophageal Stent System-Fully Covered. Donde aparece "Nota C"
junto a un número RMN, esto indica que el material se utiliza en la versión Evolution®
Esophageal Stent System-Fully Covered número arábigo.
El sistema Evolution® Esophageal Fully Covered Stent es una modificación de diseño

del Evolution® Esophageal Stent System- Parcialmente cubierto. Algunas de las
pruebas para la versión parcialmente cubierta son relevantes para la versión totalmente
cubierta y no se repitieron.
Introductor
La sección Introductor es un dispositivo de comunicación externa con contacto con
tejido durante un tiempo limitado. Es probable que el contacto con el paciente para
el introductor sea inferior a una hora. Por EN ISO10993-1 un dispositivo con una
duración de contacto de <24 horas hay una recomendación para las siguientes pruebas:
● Citotoxicidad
● Sensibilización
● Irritación o pruebas intracutáneas
Todas las pruebas recomendadas por en la norma EN ISO10993-1 se realizaron en el

Introductor. Las pruebas de citotoxicidad en el introductor no mostraron evidencia de
lisis celular o toxicidad y las pruebas de sensibilización no mostraron sensibilización
retardada por contacto dérmico. Para la prueba intracutánea hubo eritema y edema muy
leves del extracto de SO inyectado por vía intracutánea en conejos, pero el introductor
aún cumplía con los requisitos de la prueba. Una evaluación de seguridad biológica y
pruebas de citotoxicidad respaldan el uso del revestimiento de PTFE y el collar de acero
inoxidable.
Consulte la Tabla 4.3 para el resumen de la prueba de biocompatibilidad del introductor.
RMN Descripción Material Contact Prueba Número de prueba
o con el
paciente
28-096 Introductor Pebax 3533 con 40% Sí Estudi NAMSA
o de citotoxicidad
consejo del bario Uso de la ISO 07T_37792_02
sistema
(catéter interno) Método de elución
18-100 Tubos (catéter Polieteretercetona Sí
interno )
15-274 Bandas de Platino con 10% Sí
marcadores de iridio Maximización ISO NAMSA
18-122 Empujador Tubos radiopacos Sí Estudio de 07T_37792_03
(catéter de polietileno sensibilización -
interno ) Extraer 07T_37792_04
16-022 Catéter Pebax 7233, Sí
Nota A externo trenzado con acero
inoxidable 304, ISO Intracutáneo NAMSA
forrado de etileno Estudio- Extracto 07T_37792_05
propileno fluorado. 07T_37792_06
Subcarbonato de
bismuto en punta
Pebax 7233
16-026 Sonda de Vestamida Sí
bilumen
(catéter
interno )
28-125 Cable de Nitinol Sí
retención
15-079 Protecció Politetrafluoroetilo Sí
n del ne
cable de
retención
21-077 Cánula Acero inoxidable 304 No
de
soporte
(catéter
interno)
10-146 Bucle de Acero inoxidable 304 No No se requiere prueba No se requiere
cánula de prueba
alambre de
retención
10-148 Cánula de Acero inoxidable 304 No No se requiere prueba No se requiere
soporte prueba
introductoria
(catéter
interno)
10-150 Cánula Acero inoxidable No No se requiere prueba No se requiere
prueba
16-030 Catéter Pebax 7233, trenzado Sí Citotoxicidad NAMSA
Nota B
externo con acero inoxidable (***PTF Estudio utilizando la 09T_43167_03
ISO
Nota C
304, forrado de PTFE . Forro E Método de elución
Bismuto es
subcarbonato en Indirecto Seguridad Biológica NAMSA
Punta Pebax 7233 paciente Evaluación 08G_47519_01
Contacto)
Maximización ISO NAMSA
Estudio de 07T_37792_03
sensibilización -
Extraer 07T_37792_04
o con el
paciente
Estudio NAMSA
Intracutáneo ISO - 07T_37792_05
Extracto 07T_37792_06
28-172 Collar Acero inoxidable 304 Sí Estudio de NAMSA

Nota B distal PERT citotoxicidad 09T_43167_03
Nota utilizando el
C método de elución
ISO NAMSA
08G_47519_01
Evaluación de la
seguridad
biológica
®
Tabla 4.3: Evolución Sistema de Stent Esofágico: Materiales Introductores.
Stent
La parte del stent del dispositivo está en la categoría de implante, con contacto
permanente con el tejido en el esófago. LA NORMA ISO10993-1 recomienda que un
dispositivo con este nivel de contacto se someta a pruebas para:
● Citotoxicidad
● Toxicidad sistémica aguda
● Toxicidad subaguda y subcrónica
● Genotoxicidad
● Implantación
EN ISO10993-1 también recomienda que se considere la toxicidad crónica y la

carcinogenicidad.
La prueba se completó inicialmente en el dispositivo parcialmente cubierto (sin el lazo

de lazo de lazo UHMWPE, PTFE verde y lazo de lazo de lazo de poliéster impregnado
de PTFE). La biocompatibilidad para los lazos de lazo se evaluó por separado.
La genotoxicidad se realizó en los componentes del stent evolution® esofágico

System-Fully Covered: alambre de nitinol, silicona (cubierta del stent), PTFE verde
y UHMWPE). A partir de los resultados de estas pruebas, estos materiales se
consideraron no mutanagénicos para las cepas del probador y no indujeron
micronúcleos en ratones. Además, se realizó una evaluación de riesgo biológico y
una caracterización química con evaluación de riesgos en los materiales del stent
(NAMSA 07G_34442_01 y WuXi Apptec informe 11-2594 Versión 1 (BA11.009-
GG)) que apoyan que la genotoxicidad no es un riesgo significativo.
Tampoco se realizó carcinogenicidad ya que no hay indicios de que ninguno de los
materiales utilizados en el stent sea cancerígeno.
Las pruebas de toxicidad crónica se realizaron como parte de las pruebas de implantación y
como un requisito de la FDA. Las pruebas de implantación se fusionaron con una prueba de
toxicidad subcrónica de 4 semanas y el estudio de toxicidad crónica de 13 semanas para
minimizar el número de animales analizados.
Para las pruebas de biocompatibilidad realizadas en el stent, las pruebas de citotoxicidad no
mostraron evidencia de lisis celular o toxicidad y las pruebas de sensibilización no mostraron
contacto dérmico retardado sensibilización. Para la prueba intracutánea hubo eritema y edema
muy leves del extracto de SO inyectado por vía intracutánea en conejos, pero el stent aún
cumplía con los requisitos de la prueba. No hubo evidencia de toxicidad sistémica aguda.
Durante las 4 semanas de implantación no hubo evidencia de toxicidad sistémica, ninguna
reacción tisular macroscópica local significativa en comparación con el control y
microscópicamente el artículo de prueba se clasificó como no irritante en comparación con el
artículo de control. Durante las 13 semanas de implantación no hubo efecto sobre los
parámetros hematológicos y de química clínica.
El stent nitinol se limpia como parte del proceso de fabricación. Toda la fabricación en Cook
se lleva a cabo en un entorno controlado donde se definen todos los materiales permitidos. Todas
las muestras analizadas han sido procesadas a través de la CMA de Cook, por lo que cualquier
consumible o residuo se habrá contabilizado durante las pruebas de biocompatibilidad en el
Evolución® Sistema de stent esofágico .
El stent ha sido probado para la corrosión bajo VAL07-0022. Esta validación expuso Evolution
Esophagael Stents a un ambiente gástrico y de saliva. No se observó corrosión significativa
para el stent. La estabilidad de los materiales del stent ayuda a mantener un estado de
biocompatibilidad favorable.
El nitinol en el stent es suministrado por Fort Wayne Metals y es su grado NiTi # 1. El grado
NiTi#1 de nitinol excede los requisitos de la Especificación Estándar ASTM F2063-05 para
aleaciones de memoria de forma de níquel-titanio forjado para dispositivos médicos e implantes
quirúrgicos. El nitinol de grado ASTM F2063-05 se ha utilizado en implantes médicos desde
1972.
Lazos de lazo
Poliéster impregnado de politetrafluoretileno verde (PTFE) tevdek (nota A)

El material de sutura Tevdek ha sido probado para la biocompatibilidad por Cook Urological de
acuerdo con las pruebas de biocompatibilidad sugeridas por la tabla en EN ISO10993-
1. Todas estas pruebas fueron exitosas y apoyan el uso de la sutura Tevdek como un asa de
sutura en el stent esofágico Evolution® parcialmente cubierto. En las pruebas de toxicidad
sistémica de 4 y 13 semanas, el material de Tevdek mostró signos de ser un ligero irritante
bajo examen microscópico. En un estudio de implantación muscular ISO de 2 semanas , el
Tevdek se clasificó como un irritante moderado bajo examen microscópico. La evidencia de
irritación microscópica leve a moderada ha desaparecido a los 26 años, como se evidencia en el
estudio de 26 semanas del Estudio de Implantación Muscular ISO. Macroscópicamente, la
sutura de Tevdek no parece ser irritante ni en las pruebas de toxicidad sistémica ni en las
pruebas de implantación. Se puede ver que la irritación microscópica disminuye con el tiempo
después de la implantación y finalmente desaparece. La irritación observada en estos estudios
es peor caso en el que la sutura de Tevdek se implanta directamente en el tejido. En uso con el
Evolution® Esophageal Stent parcialmente cubierto, la sutura de Tevdek tendrá contacto
superficial con el tejido como peor de los casos. Teniendo en cuenta que la irritación es solo a
nivel microscópico y que desaparece con el tiempo, todos los demás datos de
biocompatibilidad exitosos documentados en TST10-023, puede Se concluye que la sutura de
Tevdek es apta para su propósito como sutura en el Stent Esofágico Evolution® parcialmente
cubierto desde una perspectiva de biocompatibilidad.
Polietileno de ultra alto peso molecular (UHMWPE)

Las pruebas de biocompatibilidad se llevaron a cabo en este material de acuerdo
con las pruebas de biocompatibilidad sugeridas por la tabla en EN ISO10993-1. Esta
prueba fue exitosa y apoya el uso de este material en el Sistema de Stent Esofágico
Evolution® (tanto parcial como totalmente cubierto).
PTFE verde (Nota C)

El material de PTFE verde se utiliza como parte de la función de agarre en el
evolution® Esophageal Stent System-Fully Covered (versión 2). Las pruebas de
biocompatibilidad se llevaron a cabo en este material de acuerdo con las pruebas de
biocompatibilidad sugeridas por la tabla en EN ISO10993-1. Esta prueba fue exitosa
y apoya el uso de este material en el Evolution® Esophageal Stent System-Fully
Covered (versión 2).
Consulte la Tabla 4.4 para el resumen de la prueba de biocompatibilidad del stent.

o con el
paciente
25-403 Alambre de Alambre de nitinol Sí Estudio de NAMSA
stent citotoxicidad
Uso de la ISO 07T_37792_02
Método de elución 07T_33449_02

sensibilización -
Membran Nusil grado de Sí Extraer 07T_37792_04
N/A a de silicona MED-4755 07T_33449_03
silicona 07T_33449_04
ISO Intracutáneo NAMSA

Estudio- Extracto 07T_37792_05
07T_37792_06
07T_33449_05
10-145 Tántalo Sí 07T_33449_06
Bandas
de
marca
dores
o con el
paciente
Estudio de NAMSA
Toxicidad 07T_33449_07
Sistémica ISO - 07T_33449_08
Extracto
NAMSA
Estudio de toxicidad 07T_33449_09
sistémica de cuatro
semanas en ratas
después de un
implante
subcutáneo NAMSA
07T_33449_13
Estudio de
toxicidad
sistémica de
trece semanas
en ratas después
de un implante NAMSA
subcutáneo 11T_56063_04
y
Genotoxicidad- 11T_56063_05
Estudio de mutación
inversa
NAMSA
bacteriana
11T_56063_02
(95%Extracto
y
de
11T_56063_03
etanol y extracto
salino)
NAMSA
12T_34552_03
Genotoxicidad-
Estudio de
micronúcleos de
sangre periférica en NAMSA
ratones 07G_34442_01
Genotoxicidad:
ensayo de linfoma
de ratón con una
prueba de
determinación del Informe WuXi
rango de dosis Apptec 11-
2594
Evaluación del Versión 1
riesgo biológico (BA11.009-GG)
del dispositivo
SEMS (stent
metálico
esofágico
recubierto de
silicona)
Caracterización
química y
evaluación de
riesgos
20-081 Lazo de lazo Tevdek Verde Sí Estudio de NAMSA

citotoxicidad
o con el
paciente
Nota A Politetrafluoretileno Uso del 08T_28881_01
método de
(PTFE) impregnado
elución ISO
Poliéster Maximización ISO NAMSA
Estudio de 08T_28882-01 y
sensibilización -
Extraer 08T_28882-02
NAMSA
Estudio de 08T_28871_01 y
irritación 08T_28871_02
vaginal ISO
Estudio de NAMSA
Toxicidad 08T_28879_01 &
Sistémica ISO -
08T_28879_02
Extracto
Genotoxicidad-
NAMSA
Estudio de
08T_28869_02
mutación inversa
bacteriana
(95% Etanol
Extracto)
NAMSA
Genotoxicidad-
08T_28869_01
Reverso
bacteriano
Estudio de mutación
( Extracto salino)
NAMSA
Estudio de
08T_28883_01 &
micronúcleos de
08T_28883_02
sangre periférica en
ratones
NAMSA
Genotoxicidad:
08T_28870_01 &
Ensayo de linfoma
08T_28870_02
de ratón
Estudio de
NAMSA
toxicidad
08T_34181_01
sistémica de 4
semanas en
ratas que siguen
Subcutáneo
Implantar
Estudio de
NAMSA
toxicidad sistémica
08T_34175_01
de 13 semanas en
ratas después
Subcutáneo
o con el
paciente
Implantar
Músculo ISO
Estudio de NAMSA
Implantación -
2 Semanas 08T_29180_01
Músculo ISO
Estudio de NAMSA
Implantación -
26 Semanas 08T_29179_01
15-331 Lazo de lazo PTFE Verde Sí Estudio de NAMSA
Nota C de lazo: citotoxicidad 11T_42871_02
función de utilizando el
agarre método de
elución ISO NAMSA
11T_42871_05
Estudio de y
sensibilización a la 11T_42871_06
maximización ISO -
Extracto NAMSA
11T_42871_07
y
Estudio 11T_42871_08
Intracutáneo ISO -
Extracto NAMSA
11T_42871_03
y
11T_42871_04
Estudio de
Toxicidad
Sistémica ISO - NAMSA
Estudio de NAMSA
implantación 11T_56687_12
subcutánea ISO en
conejos -
Implantación de 2
semanas
NAMSA
11T_56687_08
Estudio de
toxicidad
sistémica de 4
semanas en
ratas después de NAMSA
un implante 11T_56687_01
subcutáneo
Estudio de
de 13 semanas en
ratas después de
un implante
subcutáneo
Estudio de
de 26 semanas en
o con el
paciente
Ratas después
de un
implante
subcutáneo
Genotoxicidad- NAMSA
mutación inversa y
bacteriana (95% 11T_56063_05
de extracto de
etanol y extracto
salino)
NAMSA
Genotoxicidad- 11T_56063_02
Estudio de y
micronúcleos de 11T_56063_03
sangre periférica en
ratones NAMSA
12T_34552_03
Genotoxicidad:
ensayo de linfoma
de ratón con una
Informe WuXi
prueba de
Apptec 11-
determinación del
2594
rango de dosis
Versión 1
(BA11.009-GG)
Caracterización
química y
evaluación de
riesgos
25-463 Lazo de lazo Sutura de fibra de Sí Estudio de NAMSA
fuerza, USP Tamaño citotoxicidad 11T_43564_01
0 Blanco Polietileno utilizando el
de ultra alto peso método de
molecular elución ISO NAMSA
(UHMWPE) 11T_43564_04
Estudio de y
maximización ISO -
Extracto NAMSA
11T_43564_06
y
Intracutáneo ISO -
Extracto NAMSA
11T_43564_02
y
Toxicidad
Sistémica ISO -
NAMSA
Estudio de
implantación
subcutánea ISO en
conejos - 2
semanas
o con el
paciente
implantación
Sistémico de 4
semanas NAMSA
Estudio de toxicidad
en
Ratas siguiendo 11T_56687_12
Subcutáneo
Implantar
Sistémico de 13
semanas
Estudio de toxicidad NAMSA
en
Subcutáneo
Implantar
Sistémico de 26
semanas
Estudio de toxicidad NAMSA
en
Subcutáneo
Implantar
Genotoxicidad-
Reverso bacteriano NAMSA
Estudio de mutación 11T_56063_04
(95% Etanol y
Extracto y solución 11T_56063_05
salina
Extracto)
Genotoxicidad-
Periférico de ratón NAMSA
Micronúcleo 11T_56063_02
sanguíneo
Estudiar y
11T_56063_03
Genotoxicidad: Ratón
Ensayo de linfoma NAMSA
con un rango de dosis 12T_34552_03
Prueba de búsqueda
Químico
Caracterización y Aplicación WuXi
Evaluación de riesgos informe 11-2594
Versión 1
(BA11.009-GG)
®
Tabla 4.4: Evolution Sistema de stent esofágico : Materiales de stent metálico autoexpandible
Números de pieza del stent: Parcialmente cubierto: 12-439, 12-440, 12-442 y 12-442, totalmente cubierto:
(versión 1)12-111, 12-112, 12-113, 12-292, 12-293 y 12-294, Totalmente cubierto: (versión 2) 12-
476, 12 a 477, 12 a 478, 12 a 479, 12 a 480 y 12 a 481
Asa
La mayoría de los materiales que no están en contacto con el paciente están contenidos
dentro del mango como engranajes y poleas. Estos materiales no tendrán contacto con
el paciente o el médico. El médico tendrá contacto con la cubierta exterior del mango,
la cerradura de seguridad, el gatillo del bastidor y el interruptor de dirección. Todos
estos componentes están hechos de materiales de tipo policarbonato que no producirán
un residuo que pueda transferirse a un paciente. No existe ningún riesgo para la
biocompatibilidad planteado por los materiales que no están en contacto con el
paciente.
El adaptador luerlock femenino es contacto indirecto con el paciente y las pruebas
completadas en el dispositivo Evolution® Colonic/Duodenal incluyen este componente.
Consulte la Tabla 4.5 para ver el resumen de la prueba de biocompatibilidad de Handle.

o con el
paciente
28-098 Engranaje Acetal – DuPont No No se requiere No se requiere
1 grado Delrin prueba prueba
(engranaje 500P NC010
de
transmisió
n izquierdo
)
28-099 Engranaje 2 Acetal – DuPont No No se requiere No se requiere
(engranaje grado Delrin prueba prueba
de polea 500P NC010
izquierda )
de 500P NC010
transmisión
derecho )
(ralentí grado Delrin prueba prueba
derecho ) 500P NC010
de polea 500P NC010
derecha )
de 500P NC010
accionamien
to del gatillo
)
28-104 Polea de Acetal – DuPont No No se requiere No se requiere

accionamiento grado Delrin prueba prueba
500P NC010
28-105 Poleas de Acetal – DuPont No No se requiere No se requiere
correa grado Delrin prueba prueba
(delantera 500P NC010
y trasera)
28-107 Leva de Acetal – DuPont No No se requiere No se requiere
rodillo grado Delrin prueba prueba
inactivo 500P NC010
28-108 Lanzadera Grado de No No se requiere No se requiere
policarbonato prueba prueba
Lexan 241R
28-109 Gorra de Lexan de No No se requiere No se requiere
lanzadera grado de prueba prueba
80 policarbonato
o con el
paciente
241R
28-111 Disparador de Grado de No No se requiere No se requiere
bastidor policarbonato prueba prueba
Lexan 241R
28-112 Grado de No No se requiere No se requiere
Interrupt policarbonato prueba prueba
or de Lexan 241R
dirección
28-114 Zócalo FLLA Lupilon No No se requiere No se requiere
GSH2010R2 prueba prueba
(10% de
policarbonato
relleno de
vidrio)
25-067 Adaptado Policarbonato Indirecto Estudio de NAMSA
r– (80130) citotoxicidad 08T_21166_02
luerlock utilizando el
hembra método de NAMSA
elución ISO 08T_21166_05
08T_21166_06
Estudio de
sensibilización a la NAMSA
maximización ISO - 08T_21166_03
Estudio
Intracutáneo ISO -
Extracto
28-117 Primavera - Grado de No No se requiere No se requiere
post policarbonato prueba prueba
Lexan 241R
28-119 Mango de la PC / ABS No No se requiere No se requiere
carcasa (Mezcla de prueba prueba
exterior policarbonato /
izquierda acrilonitrilo
butadieno
estireno)
grado cicología
C2950
28-120 Maneje la PC / ABS No No se requiere No se requiere
carcasa (Mezcla de prueba prueba
exterior a la policarbonato /
derecha acrilonitrilo
butadieno
estireno)
grado cicología
C2950
28-118 Cerradura de Grado de No No se requiere No se requiere
seguridad policarbonato prueba prueba
Lexan 241R
30-330 SEMS Acero No No se requiere No se requiere
Muelle de inoxidable con prueba prueba
compresión recubrimiento
de PTFE
28-154 Correa de Policloropreno/gl No No se requiere No se requiere
transmisión asscord/ prueba prueba
Optibelt 250 poliamida
XL
025
o con el
paciente
28-124 Eje de la Acero No No se requiere No se requiere
polea de inoxidable prueba prueba
transmisión 304
28-122 Eje del Acero No No se requiere No se requiere
engranaje inoxidable prueba prueba
de 316
transmisió
n
28-123 Pin de ralentí Acero No No se requiere No se requiere
inoxidable prueba prueba
304
28-144 Reparación Aluminio No No se requiere No se requiere
de poleas prueba prueba
de
accionamient
o
90-242, Punto de FASSON EN 85 No No se requiere No se requiere
90-243, no TOP Blanco / prueba prueba
90-244 devolución S692N / BG40
o etiqueta Blanco
90-245 Parcialmen
Nota A
te Cubierto
90-274 Punto de FASSON EN 85 No No se requiere No se requiere
90-276 no TOP Blanco / prueba prueba
90-312 etiqueta Blanco
90-314 Totalment
90-316 e cubierto
Nota B
90-374 Punto de FASSON EN 85 No No se requiere No se requiere
90-376 no TOP Blanco / prueba prueba
90-380 etiqueta Blanco
90-382 Totalment
90-384 e cubierto
Nota C
Tabla 4.5: Evolución® Sistema de Stent Esofágico: Materiales de Mango.
Consumibles
Los consumibles utilizados en la fabricación de Evolution® Esophageal Stent System
son un fluido de silicona utilizado como lubricante en el stent, disolvente y cebador
nusil utilizado durante el stent fabricación, y adhesivos Loctite y una imprimación
Loctite utilizada en la sección introductoria. El disolvente utilizado es tolueno y se
utiliza para mezclar silicona durante el recubrimiento del stent. El tolueno se
evapora durante el proceso de curado del stent, que es de 200 ° C durante 30
minutos. Las suturas enumeradas en la tabla 4.6 se utilizan para la carga del stent y
no forman parte del dispositivo terminado.
Las pruebas de biocompatibilidad de los consumibles utilizados en la fabricación

del Sistema de Stent Esofágico Evolution® se resumen en la Tabla 4.6. Los
resultados de la prueba se discuten en las secciones Introductor y Stent.
o con el
paciente
25-409 Fluido de Lubricante Sí Evaluación del NAMSA
silicona riesgo biológico 07G_34442_01
MED- 400 del dispositivo
SEMS (stent
metálico
esofágico
recubierto de
silicona)
25-066 Loctite 4061 Adhesivo Sí Consulte la tabla 4.3 para las
35-001 Loctite Adhesivo Sí pruebas de biocompatibilidad de los
20268 materiales introductores del sistema
/26073 de stent esofágico Evolution®.
/ 4013
37-036 Loctite 7701 Primer Sí
25- Solvente Tolueno No Tabla de referencia para pruebas
4025 de biocompatibilidad del stent
N/A Nusil MED6-161 Sí esofágico.
Prime
r
N/A Hilo de 3.0 TEVDEK BLANCO No No se No se requiere
Nota B sutura (1110-TW). requiere prueba
3.0 prueba
blanco
Tevdek
20-081 Sutura Tevdek Green 1113-T No No se No se requiere
Nota A Politetrafluoretileno requiere prueba
Nota C prueba
(PTFE) Impregnado
Poliéster
®
Tabla 4.6: Evolución Sistema de stent esofágico: Consumibles
Selección de dispositivos para pruebas de biocompatibilidad

Todos los productos de la gama Evolution® Esophageal Stent System comparten
materiales comunes (con las diferencias descritas anteriormente). Se llevaron a cabo
pruebas en el producto EVO-20-25-15-E para obtener datos de biocompatibilidad
sobre el stent común y los materiales introductores en toda la gama de productos
Evolution Esophageal. Esto se utilizó para representar el introductor y el stent para
pruebas de citotoxicidad, sensibilización e irritación o intracutáneas. Los siguientes
stents Parte 12-034 y 12-035 fueron elegidos para representar todas las pruebas de
biocompatibilidad de stent solamente. La FLLA (RMN 25-
067) es común a los productos Evolution® Colonic/Duodenal y las pruebas en estos
productos incluyeron este componente.
Se utilizan datos adicionales de biocompatibilidad / información sobre los materiales
para justificar dónde hubo cambios en los materiales. Se llevaron a cabo ensayos
adicionales cuando fue necesario para los cambios de diseño en los que se introdujeron
nuevos materiales y también se probaron los nuevos requisitos para la indicación
benigna (por ejemplo, genotoxicidad). Esta prueba se llevó a cabo en dispositivos
híbridos / stents, que incorporaron los nuevos materiales del cambio de diseño.
Conclusión:
El sistema de stent esofágico Evolution® cumple con los requisitos de la norma EN

ISO10993-1 en función de las pruebas de biocompatibilidad realizadas, el
conocimiento de los materiales de fabricación y la fabricación controlada Procesos.
La biocompatibilidad del sistema de stent esofágico Evolution® está corroborada por

las pruebas descritas en TST08-002, TST09-062, TST10-023, TST08-083, TST08-
037
y BA11.010-A. Las pruebas realizadas bajo BA11.010-A incluyen lo siguiente:
BA11.010-F, BA11.010-I, BA11.010-G, BA11.010-H, BA11.010-K, BA11.009-K,
BA11.009-Q, BA11.009-M, BA11.009-O, BA11.009-V, BA11.009-Y, BA11.009-W,
BA11.009-X, BA11.009-CC, BA11.009-EE y BA11.009-GG.
Todos los informes de prueba e informes de biocompatibilidad se archivan en Control de

documentos o en asuntos regulatorios.
4.4.2 El sistema de stent duodenal / colónico Evolution®
El uso previsto para los sistemas de stent duodenal y colónico Evolution® se

describe en la sección 3.2.
Evolution® Duodenal/Colonic Stent System tiene dos tipos de contacto corporal según
ISO10993-1. Los dos tipos diferentes de contacto corporal son experimentados por el
Introductor y los componentes stent del Sistema de Stent Duodenal/Colónico
Evolution®.
Introductor
La sección Introductor es un dispositivo de comunicación externa con contacto con
tejido durante un tiempo limitado. Es probable que el contacto con el paciente para
el introductor sea inferior a una hora. Por ISO10993-1 un dispositivo con una duración
de contacto de <24 horas hay una recomendación para las siguientes pruebas:
● Citotoxicidad
Todas las pruebas recomendadas por ISO10993-1 se realizaron en el Introductor. Las

pruebas de citotoxicidad en el introductor no mostraron evidencia de lisis celular o
toxicidad. Las pruebas de sensibilización no mostraron sensibilización retardada por
contacto dérmico en el conejillo de indias. Para la prueba intracutánea no hubo
eritema ni edema del extracto sc inyectado por vía intracutánea en conejos. Hubo
eritema y edema muy leves del extracto de SO, pero el Introductor aún cumplió con
los requisitos de la prueba ya que la diferencia entre los extractos de prueba y la
puntuación media de control correspondiente fue inferior a 1,0.
Las pruebas anteriores se repitieron para la versión 2 del catéter externo. Las
pruebas de citotoxicidad no mostraron evidencia de que el artículo de prueba
causara lisis celular o toxicidad y las pruebas de sensibilización no mostraron
sensibilización por contacto dérmico retardado. Para la prueba intracutánea hubo
eritema y edema muy leves del extracto de SO inyectado por vía intracutánea en
conejos, pero el catéter externo aún cumplía con los requisitos. de la prueba.
Consulte la Tabla 4.7 para el resumen de la prueba de biocompatibilidad del introductor.

o con el
paciente
28-095 Punta del Pebax 3533 Sí
sistema con 40%
introduct de bario
or Estudio de NAMSA
(catéter citotoxicidad 08T_21166_02
interno ) utilizando el
10-141 Tubos de Poliimida Sí método de elución
poliimida trenzada con ISO
(catéter 304V SS @ 80
interno) PIC
15-266 Introductor Tántalo Sí
o con el
paciente
Marcador
Bandas
(Interior NAMSA
Maximización ISO
Catéter)
18-123 Interior: Sí 08T_21166_05
Nylon con Sensibilización 08T_21166_06
Empujado bismuto, Estudio-Extracto
r Exterior:
introduct Nylon con
or colorante
(catéter añadido
interno)
16-024 Introduct PEEK Sí
or PEEK recocido
Tubos
(catéter NAMSA
interno ) ISO Intracutáneo 08T_21166_03
16-023 Introduct PTFE Sí Estudio- Extracto 08T_21166_04
or PTFE
Tubos
(catéter
interno )
16-025 Asa de Acero Sí
recuperaci inoxidable
ón ( catéter ASTM 302 /
interno) 304
28-141 Alambre Alambre de Sí
de nitinol
retenció
n de
nitinol
15-279 Tubería Tántalo Indirecto
18-359, Exterior Forro de PTFE, Sí Estudio de 15T_67103_04
citotoxicidad
18-360 Catéter Exterior de nylon Uso de la ISO (BA12.028-E)
y superficie Método de elución
(Borrar)
18-361 la sección distal
es
un Pebax/Nylon Conejillo de Indias 15T_67103_07 y
ISO
Copolímero), Maximización 15T_67103_08
Trenza: Estudio de (BA12.028-G)
Inoxidable sensibilización
Acero 304V
Bobina: ISO Intracutáneo 15T_67103_05 y
Inoxidable
Acero 304V Estudio en conejos 15T_67103_06
(BA12.028-F)
21-078 Cánula Acero No No se requiere No se requiere prueba
de inoxidable prueba
soporte ANSI 304
introduct
oria
(catéter
interno)
18-107 Tubo de Nylon-12 No No se requiere No se requiere prueba
nylon Natural prueba
introduct
or (
catéter
interno)
10-146 Cánula Acero inoxidable No No se requiere No se requiere prueba
prueba
o con el
paciente
304
Tabla 4.7: Evolution® Duodenal/Colonic Stent System: Introductor Materials.
Stent
La parte del stent del dispositivo está en la categoría de implante, con contacto
permanente con el tejido en el duodeno o el colon. ISO10993-1 recomienda que un
dispositivo con este nivel de contacto sea probado para:
● Citotoxicidad
● Toxicidad sistémica aguda
● Toxicidad subaguda y subcrónica
● Genotoxicidad
● Implantación
ISO10993-1 también recomienda que se considere la toxicidad crónica y la

carcinogenicidad.
Para el stent, no se realizó genotoxicidad. A partir de una evaluación del riesgo

biológico realizada en los materiales del stent (NAMSA 07G_34442_01), la
genotoxicidad no es un riesgo significativo. Tampoco se realizó carcinogenicidad ya
que no hay indicios de que ninguno de los materiales utilizados en el stent sea
cancerígeno.
Las pruebas del Stent Esofágico Evolution® se utilizaron para corroborar la

biocompatibilidad del Evolution® Duodenal/Colonic Stent como todos los materiales
en el Evolution® Duodenal/Colonic Los stents también están presentes en el
Evolution® Esophageal Stent. Los resultados de esta prueba se describen en la sección
Evolution® Esophageal Stent y los números de prueba se mencionan aquí.
El stent nitinol se limpia como parte del proceso de fabricación. Toda la fabricación
en Cook se lleva a cabo en un entorno controlado donde se definen todos los materiales
permitidos. Todas las muestras analizadas han sido procesadas a través de la CMA de
Cook, por lo que cualquier consumible o residuo se habrá contabilizado durante las
pruebas de biocompatibilidad en el Evolución® Sistema de stent esofágico .
El stent ha sido probado para la corrosión bajo VAL07-0015. Esta validación expuso
los stents enterales y colónicos de nitinol a un gástrico, bilis y fluidos pancreáticos. No
se observó corrosión significativa para el stent. La estabilidad de los materiales del
stent ayuda a mantener un estado de biocompatibilidad favorable.
El nitinol en el stent es suministrado por Fort Wayne Metals y es su grado NiTi # 1. El
grado NiTi#1 de nitinol excede los requisitos de la especificación estándar ASTM
F2063-05 para aleaciones de memoria de forma de níquel-titanio forjado para
dispositivos médicos
e Implantes Quirúrgicos. El nitinol de grado ASTM F2063-05 se ha utilizado en
implantes médicos desde 1972.
Consulte la Tabla 4.8 para el resumen de la prueba de biocompatibilidad del stent.

o con el
paciente
25-402 Alambre de Nitinol Sí Estudio de citotoxicidad NAMSA
stent utilizando
alambre el método de elución ISO 07T_37792_02
07T_33449_02
08T_21166_02

Estudio de sensibilización 07T_37792_03
-
Extraer 07T_37792_04
07T_33449_03
07T_33449_04
08T_21166_05
08T_21166_06
ISO Intracutáneo NAMSA

07T_37792_06
07T_33449_05
10-145 Bandas de Tántalo Sí 07T_33449_06
marcadores 08T_21166_03
08T_21166_04
Toxicidad sistémica ISO NAMSA

N/A Silicona Nusil Sí 07T_33449_08
Silicona
Grado Sistémico de cuatro NAMSA
MED- semanas
4755 Estudio de toxicidad en 07T_33449_09
ratas
Seguimiento subcutáneo
Implantar
Trece Semanas Sistémica NAMSA

Estudio de toxicidad en 07T_33449_13
ratas
Seguimiento subcutáneo
Implantar
Riesgo biológico NAMSA

Evaluación del SEMS 07G_34442_01
dispositivo (recubierto de
silicona)
Stent metálico esofágico )
Tabla 4.8: Evolution® Duodenal/Colonic Stent System: Self Expanding Metal Stent
Asa
La mayoría de los materiales que no están en contacto con el paciente están contenidos
dentro del mango como engranajes y poleas. Estos materiales no tendrán contacto con
el paciente o el médico. El médico tendrá contacto con la cubierta exterior del mango,
la cerradura de seguridad, el gatillo del bastidor y el interruptor de dirección. Todos
estos componentes están hechos de materiales de tipo policarbonato que no producirán
un residuo que pueda transferirse a un paciente. No existe ningún riesgo para la
biocompatibilidad planteado por los materiales que no están en contacto con el
paciente. El adaptador luerlock hembra se probó como parte del introductor y los
resultados se discuten allí.
Consulte la Tabla 4.9 para ver el resumen de la prueba de biocompatibilidad de Handle.

o con el
paciente
28-098 Engranaje Acetal – No No se requiere prueba No se requiere
1 DuPont prueba
(engranaje grado Delrin
de 500P NC010
transmisió
n izquierdo
)
28-099 Engranaje 2 Acetal – No No se requiere prueba No se requiere
(engranaje DuPont prueba
de polea grado Delrin
izquierda ) 500P NC010
de grado Delrin
transmisión 500P NC010
derecho )
(ralentí DuPont prueba
derecho ) grado Delrin
500P NC010
de polea grado Delrin
derecha ) 500P NC010
de grado Delrin
accionamien 500P NC010
to del gatillo
)
28-104 Polea de Acetal – No No se requiere prueba No se requiere

accionamiento DuPont prueba
grado Delrin
500P NC010
28-105 Poleas de Acetal – No No se requiere prueba No se requiere
correa DuPont prueba
(delantera grado Delrin
y trasera) 500P NC010
o con el
paciente
28-107 Rodillo de Acetal – No No se requiere prueba No se requiere
leva DuPont prueba
grado Delrin
500P NC010
28-108 Lanzadera Grado de No No se requiere prueba No se requiere
policarbonato prueba
Lexan 241R
28-110 Shuttle-Cap- Lupilon No No se requiere prueba No se requiere
34 GSH2010R2 prueba
(10% de
policarbonato
relleno de
vidrio)
28-111 Disparador de Grado de No No se requiere prueba No se requiere
bastidor policarbonato prueba
Lexan 241R
28-112 Grado de No No se requiere prueba No se requiere
Interrupt policarbonato prueba
or de Lexan 241R
dirección
28-113 Boquilla-34 Policarbonato No No se requiere prueba No se requiere
GE Plásticos prueba
Grado Lexan
241R
25-067 Adaptado Policarbonato Indirecto Estudio de citotoxicidad NAMSA
r– (80130) utilizando el método 08T_21166_02
luerlock de elución ISO
hembra NAMSA
maximización ISO -
Extracto NAMSA
08T_21166_03
Intracutáneo ISO -
Extracto
28-114 Zócalo FLLA Lupilon No No se requiere prueba No se requiere
GSH2010R2 prueba
(10% de
policarbonato
relleno de
vidrio)
28-117 Primavera - Grado de No No se requiere prueba No se requiere
post policarbonato prueba
Lexan 241R
28-146 TTS Capa PC/ABS No No se requiere prueba No se requiere
exterior (Policarbonato prueba
izquierda /Acrilonitrilo
butadieno
o con el
paciente
mezcla de
estireno ) GE
Plastics Grade
Cycology
C2950
28-147 TTS PC/ABS No No se requiere prueba No se requiere
Carcasa (Policarbonato prueba
exterior /Mezcla de
derecha acrilonitrilo
butadieno
estireno ) GE
Plastics Grade
Cycology
C2950
28-118 Cerradura de Grado de No No se requiere prueba No se requiere
seguridad policarbonato prueba
Lexan 241R
30-330 SEMS Acero No No se requiere prueba No se requiere
Muelle de inoxidable con prueba
compresión recubrimiento
de PTFE
28-155 Correa de Policloroprono No No se requiere prueba No se requiere
transmisió / glasscord / prueba
n Optibelt poliamida
316XL 025
77º
28-124 Eje de la polea Acero No No se requiere prueba No se requiere
inoxidable prueba
304
28-122 Eje de Acero No No se requiere prueba No se requiere
engranajes inoxidable prueba
316
28-123 Pin de ralentí Acero No No se requiere prueba No se requiere
inoxidable prueba
304
28-144 Reparación Aluminio No No se requiere prueba No se requiere
de poleas prueba
de
accionamient
o
90-246 Sin FASSON EN No No se requiere prueba No se requiere
90-247 etiqueta 85 TOP Blanco prueba
90-248 de / S692N /
90-249 devolució BG40 blanco
90-250 n
90-251
Tabla 4.9: Evolution® Duodenal/Colonic Stent System: Handle Materials.
Consumibles
Los consumibles utilizados en la fabricación del Sistema de Stent Duodenal/Colónico
Evolution® son adhesivos Loctite Las pruebas de biocompatibilidad en los
consumibles utilizados en la fabricación del Evolution® El sistema de stent
duodenal/colónico se resume en la Tabla 4.10. Los resultados de la prueba se discuten
en las secciones Introductor y Stent.
o con el
paciente
25-066 Loctite 4061 Adhesivo Sí Estudio de citotoxicidad NAMSA
utilizando el método 07T_37792_02
de elución ISO
NAMSA
maximización ISO -
Extracto
NAMSA
07T_37792_05
Intracutáneo ISO -
Extracto
35-001 Loctite Adhesivo No No se requiere prueba No se requiere
20268 prueba
/26073
/ 4013
N/A Permabon Adhesivo No No se requiere prueba No se requiere

d 820 prueba
Dymax UV (Ayudas a la
fabricación en
catéter externo
versión 2)
®
Tabla 4.10: Evolution Duodenal/Colonic Stent System: Consumibles
Selección de dispositivos para pruebas de biocompatibilidad

Todos los productos de la gama Evolution® Duodenal/Colonic Stent System utilizan
los mismos materiales, por lo que cualquier stent e introductor que se haya elegido,
todos los productos de la gama estar representado. Se utilizó EVO-25-30-10-C para
representar el introductor y el stent para pruebas de citotoxicidad, sensibilización e
irritación o intracutáneas. Parte 12-
Se eligieron 034 y 12-035 del® Evolution Esophageal Stent System para representar
todas las pruebas de biocompatibilidad de stent solamente. Se hizo referencia a las
pruebas con EVO-20-25-15-E para obtener información adicional de apoyo para la
citotoxicidad, la sensibilización y las pruebas intracutáneas.
Conclusión:
El sistema de stent duodenal/colónico Evolution® cumple con los requisitos de

iso10993-1 basado en las pruebas de biocompatibilidad realizadas, el conocimiento de
los materiales de fabricación y la fabricación controlada Procesos.
Todas las pruebas de biocompatibilidad para el sistema de stent duodenal/colónico

Evolution® están documentadas en BA12.028-A. Los informes de prueba se archivan
en Control de documentos. .
4.5 Esterilidad
Cook Ireland sterilise Evolution® Sistema de stent esofágico / duodenal / colónico en

Synergy Health Ireland Limited, en Tullamore, Condado de Offaly. El método de
esterilización es por óxido de etileno (EO) utilizando un ciclo de esterilización validado
de acuerdo con EN ISO 11135 "Esterilización de productos sanitarios - Óxido de
etileno: Requisitos para el desarrollo, validación y control rutinario de un proceso de
esterilización de productos sanitarios. ".
Synergy Health Ireland Limited cuenta con la certificación 11135 y realiza la

esterilización de los productos de Cook Ireland en una línea validada en sus
instalaciones.
Con el fin de esterilizar los productos en este archivo técnico; han sido validados a
un nivel de garantía de esterilidad de 10-6. Para obtener detalles sobre el Informe de
esterilización del producto y otra información de apoyo, consulte la Revisión de
esterilización que se encuentra en el Apéndice G. Los detalles sobre la información
residual también figuran en el Apéndice G.
EO Residue cumple con la norma EN ISO 10993-7 (Evaluación biológica de

dispositivos médicos Parte 7: Residuos de esterilización de óxido de etileno). Las
pruebas de residuos se documentan en la siguiente tabla.
Los niveles de carga biológica se monitorean y controlan según D00059708

(QSI0924). La validación y las pruebas de carga biológica para la gama de productos
Evolution® se documentan en la siguiente tabla.
Producto Residuo Carga biológica
Evolución® Sistema de Stent TST08-038 TST08-038

Duodenal/Colónico Esofágico. TST16-061 TST16-062
Evolution® Parcialmente cubierto TST10-044 TST08-003,
sistema de stent esofágico TST09-059
TST10-024
Evolution® Sistema de stent esofágico TST09-059 TST09-059
totalmente cubierto (versión1)
Evolution® Sistema de stent esofágico TST11-029 TST11-029
totalmente cubierto (versión 2)
Tabla 4.11: Evolución® de los números de los informes de pruebas residuales y de carga
biológica.
Los registros de validación de esterilización son mantenidos por el Departamento de Control

de Documentos.
4.6 Embalaje
El producto se coloca en una bandeja con tubo protector sobre el extremo distal del
producto. Hay una tapa de bandeja colocada sobre la parte del mango del producto.
El producto en la bandeja se coloca en doble bolsa, cada bolsa se sella individualmente.
Para los productos Evolution® Esophageal, la bolsa interior después de sellada se
pliega en un extremo y se mantiene en su lugar con una etiqueta transparente.
Después de la bolsa, el producto se coloca en una caja. Consulte las siguientes tablas
para obtener detalles de los materiales de embalaje.
Código de producto Micrómet Material

Component ro Especificació
e de Número n del material
embalaje (CPN)
EVO-20-25-(X)X-E, Tubo 18-125 PPNT (Polipropileno) RMS0044
EVO-20-25-XX. X-E protector
EVO-FC-(R)XX-XX-(X)X-E
de stent
Bandeja 20-118 GPET (tereftalato de DWG0349
de polietileno)
embalaje
Tapa de la 20-117 GPET (tereftalato de DWG0350
bandeja polietileno)
de
embalaje
Bolsa interior 26-007 Película PET/PE : 35890-G DWG0009
o grado equivalente
12/50, Mylar, Tyvek 1073B
CR27
Bolsa exterior 26-008 Película pet/PE : 35890-G DWG0009
o grado equivalente
12/50
Etiqueta clara 90-403 Etiqueta transparente N/A
HC0410085-001
EVO-20-25-(X)X-E, Caja de 95-104 E Flauta Cartón CHT0037
EVO-20-25-XX. X-E producto
EVO-FC-XX-XX-(X)X-E Caja de 95-112 Cartón E-Flute CHT0037

producto
EVO-FC-R-XX-XX-(X)X-E Caja de 95-164 Cartón E-Flute CHT0037
producto
EVO-FC-R-XX-XX-(X)X-E Etiqueta 90-406 MCPrime con adhesivo RMS0195
permanente S2045N
Tabla 4.12: Evolución® Sistema de stent esofágico: Materiales de embalaje

Código de producto Micróme Material
Component tro Especificaci
e de Número ón del
embalaje (CPN) material
EVO-XX-XX-(X)X-C, Tubo 18-124 PPNT (Polipropileno) RMS0044
EVO-XX-XX-(X)X-D protector
de stent
Bandeja 20-116 PETG (Polietileno DWG0348
de Tereftalato Glicol)
embalaje
Tapa de la 20-120 PETG (Polietileno DWG0481
bandeja Tereftalato Glicol)
de
embalaje
Bolsa interior 26-005 Película PET/PE : 35890-G DWG0009
o grado equivalente
12/50, Mylar, Tyvek 1073B
CR27
Bolsa exterior 26-006 Película pet/PE : 35890-G DWG0009
o grado equivalente
12/50
EVO-XX-XX-(X)X-C Caja de 95-103 E Flauta Cartón CHT0037
producto
EVO-XX-XX-(X)X-D Caja de 95-106 E Flauta Cartón CHT0037
producto
Tabla 4.13: Evolución® de los sistemas de stents colónicos y duodenales: materiales de
embalaje
Pruebas de embalaje de productos:

La prueba de ráfaga se realiza al principio y al final de cada turno según SOP0901
(Operación del probador de ráfagas (sistema automatizado de prueba A-Pack).
El embalaje es suministrado por proveedores calificados y se inspecciona en la inspección
entrante. Estos productos se envasan de acuerdo con los siguientes procedimientos:
Evolution® Sistema de stent esofágico - Parcialmente

cubierto: PKG0085 Bolsa SEMS Productos esofágicos
PKG0086 Boxeo de productos SEMS.
Evolution® Esophageal Stent System- Totalmente cubierto:

PKG0107 Pouching Evolution Producto esofágico totalmente recubierto
PKG0108 Boxing of Evolution Producto totalmente cubierto
Evolution® Colonic Stent System y Evolution® Duodenal Stent System:

PKG0090 Pouching Instruction for Duodenal/Colonic Stent Products
PKG0091 Instrucción de boxeo para Duodenal/Colonic Stent Products
Validación del embalaje del producto:

Calificación operativa VAL0088 Revalidación de Cook Ireland Pouch Packaging que
contiene película de PET/PE 12/50.
Calificación del proceso VAL0089 Revalidación de Cook Ireland Pouch Packaging que
contiene una película de PET/PE 12/50.
VAL07-0011 describe las pruebas de integridad de transporte y embalaje (incluido

el envejecimiento) para evolution® Esophageal Stent System. Esto se resume en la
sección 4.3. Esto es aplicable para los productos esofágicos totalmente cubiertos y
parcialmente cubiertos.
Product Identification - Manufactured
Metal Stents/ Sets
ITF049-MSS
Reorder Number Product Name
EVO-20-25-8-E Evolution® Esophageal Stent System-Partially Covered

EVO-20-25-12.5-E Evolution® Esophageal Stent System-Partially Covered
EVO-FC-18-23-8-E Evolution® Esophageal Stent System- Fully Covered


EVO-FC-R-18-23-8-E Evolution® Esophageal Stent System- Fully Covered


EVO-22-27-12-D Evolution® Duodenal Stent System- Uncovered

EVO-22-27-6-D Evolution® Duodenal Stent System- Uncovered
EVO-22-27-9-D Evolution® Duodenal Stent System -Uncovered
EVO-25-30-10-C Evolution® Colonic Stent System- Uncovered

Megha Bhapkar (DV0001519) 11 May 2020 (DV0001519)

_________________________________ _______________________
Regulatory Affairs Date
Page 1 of 1
Standards listing
TECHNICAL FILE ID: ITF049-MSS
The standards used for demonstration of conformity of products referenced in this technical file Essential
Requirements Checklist are as follows:
Standards Reference No. Standards Title

EN ISO 13485: 2016 Medical Devices - Quality Management Systems - requirements for
regulatory purposes.
EN ISO 14971: 2012 Medical devices - Application of risk management to medical
devices.
EN ISO 10993-1: 2009 / AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process.
EN ISO 11135: 2014 Sterilization of healthcare products - Ethylene oxide: Requirements
for the development, Validation and routine control of a sterilization
process for medical devices.
EN ISO 14644-1: 2015 Cleanrooms and associated controlled environments - Part 1:
Classification of air cleanliness by particle concentration.
EN ISO 14644-2: 2015 Cleanrooms and associated controlled environments - Part 2:
Monitoring to provide evidence of cleanroom performance related to
air cleanliness by particle concentration.
EN ISO 10993-7: 2008 / AC :2009 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide
Sterilization Residuals.
EN 556-1: 2001 / AC :2006 Sterilization of medical devices - Requirements for medical devices to
be designated “STERILE” - Part 1: Requirements for terminally
sterilized medical devices.
EN ISO 11737-1: 2018 Sterilization of Health Care Products - Microbiological methods - Part
1: Determination of a population of microorganisms on products.
EN 1041: 2008 +A1: 2013 Information Supplied by the manufacturer of Medical Devices.
EN ISO 15223-1: 2016 Medical Devices - Symbols to be used with medical device labels,
labelling and information to be supplied Part 1: General requirements.
EN ISO 11607-1: 2009* Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging
systems.
EN ISO 11607-2: 2006* Packaging for terminally sterilized medical devices - Part 2:
Validation requirements for forming, sealing and assembly processes.
Note:
* indicates applicable to Evolution Esophageal Stent System only.
Page 1 of 2
Reviewed and Approved By: Date:
Megha Bhapkar (DV0001519) 29 April 2020 (DV0001519)

Regulatory Affairs:
Quality Systems:
Signature obtained as per DV0001519

Senior Microbiologist:

Senior Sterilisation Engineer:

Biocompatibility Specialist:
Engineering:
Clinical Communications: Signature obtained as per DV0001519
Note: Signatures of the relevant standard owners indicate reviewed and approved, for full compliance to the
applicable sections of the above standards.
Page 2 of 2
Bhapkar, Megha
From: Beglin, Annemarie

Sent: 29 April 2020 16:12
To: Bhapkar, Megha
Subject: FW: Signature Required for ITF049-MSS -Standard Listing
Attachments: 2020-03-26, Standard Listing - Redline -AO.DOCX; 2020-04-22, Standard Listing -Clean.docx
Hi Megha,
I confirm approval of the attached Standards listing for Quality Systems.
Regards
Annemarie
From: Bhapkar, Megha <Megha.Bhapkar@CookMedical.com>

Sent: 29 April 2020 09:52
To: Beglin, Annemarie <Annemarie.Beglin@CookMedical.com>; Larkin, Sandra <Sandra.Larkin@CookMedical.com>;
Daly, Bernard <Bernard.Daly@CookMedical.com>; Ni Dhomhnaill, Maire <Maire.NiDhomhnaill@CookMedical.com>;
Campbell, Triona <Triona.Campbell@CookMedical.com>; Carr, Koran <Koran.Carr@CookMedical.com>
Subject: Signature Required for ITF049‐MSS ‐Standard Listing
Hi All,
Hope you are good.
ITF049‐ MSS Standard Listing is now ready for your approval and signature as attached.
For products;
• Evolution® Esophageal Stent System‐Partially Covered

• Evolution® Esophageal Stent System‐ Fully Covered
• Evolution® Duodenal Stent System‐ Uncovered
• Evolution® Colonic Stent System‐ Uncovered
Can you please respond to this email to form your signature? The redline is also attached for reference.
Deviation Number: DV0001519

Document Number: N/A
Document Names: Standard listing for Tech. file 049.
Document Revisions: N/A
Thanks
Regards,
Megha
1
Bhapkar, Megha
From: Larkin, Sandra

Sent: 29 April 2020 13:13
To: Bhapkar, Megha
Subject: FW: Signature Required for ITF049-MSS -Standard Listing
Attachments: 2020-03-26, Standard Listing - Redline -AO.DOCX; 2020-04-22, Standard Listing -Clean.docx
Hi Megha,
Please accept this email as my approval of the attached documents as per DV0001519.

Thanks,
Sandra
Sandra Larkin
Senior Microbiologist
Cook Medical
O'Halloran Road
Limerick, Ireland
+353 61 334440 ext. 2514
www.cookmedical.com
Sandra.Larkin@Cookmedical.com
CONFIDENTIALITY NOTICE: This e-mail and any files transmitted with it are confidential and may be privileged. If you are not the
intended recipient, you may not read, copy, print, forward or use this information. If you have received this e-mail in error, please
notify the sender immediately.
From: Bhapkar, Megha <Megha.Bhapkar@CookMedical.com>

Sent: Wednesday, April 29, 2020 9:52 AM
Hi All,
Hope you are good.
ITF049‐ MSS Section 6.0 Risk is now ready for your approval and signature as attached.
For products;

1
Thanks
Regards,
Megha
2
Bhapkar, Megha
From: Daly, Bernard

Sent: 29 April 2020 11:21
To: Bhapkar, Megha
Subject: RE: Signature Required for ITF049-MSS -Standard Listing
Hi Megha,
As per deviation DV0001519, you can take this email as my approval of the standards listing for ITF049 – MSS,
 Deviation Number: DV0001519

 Document Number: N/A
 Document Names: Standard listing for Tech. File 049.
 Document Revisions: N/A
Regards,
Bernard.
From: Bhapkar, Megha

Sent: 29 April 2020 09:52
Hi All,
Hope you are good.
For products;


Thanks
Regards,
Megha
1
Bhapkar, Megha
From: Ni Dhomhnaill, Maire

Sent: 29 April 2020 10:52
To: Bhapkar, Megha
Hi Megha,
Please consider this email as signature for the biocompatibility function for ITF049‐MSS ‐Standard Listing under
deviation.

Le mór meas
Máire

Sent: 29 April 2020 09:52
Hi All,
Hope you are good.
For products;


Thanks
Regards,
Megha
1
Bhapkar, Megha
From: Campbell, Triona

Sent: 08 May 2020 12:00
To: Bhapkar, Megha
I approve the standards listing referenced below.

Sent: 06 May 2020 14:40
To: Campbell, Triona <Triona.Campbell@CookMedical.com>
Subject: FW: Signature Required for ITF049‐MSS ‐Standard Listing
Hi Triona,
Hope you are well
Can you please respond to this email with your signature for standard listing of TF 049?
Thanks
Regards,
Megha

Sent: 29 April 2020 10:33
Subject: RE: Signature Required for ITF049‐MSS ‐Standard Listing
Hi All,
In the earlier email, read “ITF049‐ MSS Section 6.0 Risk” as “ITF049‐MSS ‐Standard Listing”
Apologies for any inconvenience.
Please let me know, if anything is not clear.
Thanks
Regards,
Megha

Sent: 29 April 2020 09:52
Hi All,
1
Hope you are good.
For products;


Thanks
Regards,
Megha
2
Bhapkar, Megha
From: Carr, Koran

Sent: 29 April 2020 10:30
To: Bhapkar, Megha; Beglin, Annemarie; Larkin, Sandra; Daly, Bernard; Ni Dhomhnaill, Maire;
Campbell, Triona
Dear Megha
Approved for Clinical Communications
Regards
Koran

Sent: 29 April 2020 09:52
Hi All,
Hope you are good.
For products;


Thanks
Regards,
Megha
1
TRADUCCIÓN SIMPLE
Formato de Sistema de Calidad
Número de Documento: Revisión: Propietario SGC: Página:
D00062014 035 Cook Ireland Ltd. 1 de 1
Título: Declaración de Conformidad
Número anterior: F3203B
Fabricante:
Cook Ireland Limited,
O’Halloran Road,
National Technology Park,
Limerick, lreland.
Teléfono: + 353 61 334440
Fax: + 353 61 334441
DECLARACIÓN DE CONFORMIDAD www.cookmedical.com
Número Carpeta técnica: ITF049-MSS
Identificación de familia de productos: Clasificación (MDD, Anexo IX)

Stents metálicos, Sets IIb
(Consulte la Lista de identificación de productos para
obtener una lista de los números de modelo
asociados con la Declaración de Conformidad
Por la presente, declaramos que los productos mencionados anteriormente cumplen con la Directiva de
Dispositivos Médicos 93/42/EEC y su transposición a la legislación irlandesa y que nosotros, el fabricante
nombrado anteriormente, somos los únicos responsables de los mismos. Se aplican las siguientes normas. Toda la
documentación justificativa se conserva en las instalaciones del fabricante y del organismo notificado.
Directivas generales aplicables:

Directiva de dispositivos médicos:
DIRECTIVA DEL CONSEJO 93/42/EEC del 14 de junio de 1993 relativa a los dispositivos médicos. (MDD 93/42/EEC)
Normas:
Normas armonizadas modificadas (publicadas en el Diario Oficial de la Comunidad Europea) y Normas
Internacionales aplicables a este producto son:
detalladas en el Listado de Normas:
Organismo notificado: TÜV SÜD Product Service GmbH (0123),

Ridlerstr. 65,
80339, Munich, Alemania
Certificado: G1 033038 0037 Rev. 00 (Anexo II excepto 4)

Fecha del marcado CE inicial / Fecha de Emisión inicial del DOC: 5 de febrero del 2008
Firma:
Fecha: 12 de mayo del 2020
Nombre: Aisling O’Sullivan
Posición: Director Asuntos Regulatorios
ADVERTENCIA PROPIEDAD EXCLUSIVA CONFIDENCIAL - Este documento es propiedad de COOK Medical. Contiene información confidencial de secretos
comerciales y no debe copiarse. El documento y la información que contiene sólo pueden ser utilizados por el destinatario para el uso específico para el que fue
solicitado. Cualquier otro uso está estrictamente prohibido. Este documento debe ser devuelto a COOK Medical inmediatamente a petición de COOK Medical. Al poseer
este documento, el poseedor acepta expresamente cumplir con estos términos.
"@COPYRIGHT Cook Irelanda Ltd. 2017"
Formato: F0518A (R001, CR17-0298)

O’Halloran Road,
Limerick, lreland.
Teléfono: + 353 61 334440
Fax: + 353 61 334441
www.cookmedical.com
Identificación del producto – Fabricado

Stents metálicos / Sets
ITF049-MSS
Número de reorden Nombre del producto

EVO-20-25-8-E EVO-20-25-8-E Evolution® Esophageal Stent System-Partially Covered
EVO-20-25-12.5-E EVO-20-25-12.5-E Evolution® Esophageal Stent System-Partially Covered
EVO-FC-18-23-8-E EVO-FC-18-23-8-E Evolution® Esophageal Stent System- Fully Covered
EVO-FC-R-18-23-8-E EVO-FC-R-18-23-8-E Evolution® Esophageal Stent System- Fully Covered
EVO-22-27-12-D EVO-22-27-12-D Evolution® Duodenal Stent System- Uncovered
EVO-22-27-6-D EVO-22-27-6-D Evolution® Duodenal Stent System- Uncovered
EVO-22-27-9-D EVO-22-27-9-D Evolution® Duodenal Stent System -Uncovered
EVO-25-30-10-C- Uncovered EVO-25-30-10-C Evolution® Colonic Stent System- Uncovered
EVO-25-30-6-C- Uncovered EVO-25-30-6-C Evolution® Colonic Stent System- Uncovered
EVO-25-30-8-Cstem- Uncovered EVO-25-30-8-C Evolution® Colonic Stent System- Uncovered
Megha Bhapkar (DV0001519) 11 de mayo del 2020 (DV0001519)
Asuntos Regulatorios Fecha
Página 1 de 1
O’Halloran Road,
Limerick, lreland.
Teléfono: + 353 61 334440
Fax: + 353 61 334441
www.cookmedical.com
Listado de Normas
IDENTIFICACIÓN DEL ARCHIVO TÉCNICO: ITF049-MSS
Los estándares utilizados para la demostración de la conformidad de los productos a los que se hace referencia en
este archivo técnico Lista de verificación de requisitos esenciales son los siguientes:
N° de Referencia de las Normas Título de las Normas

EN ISO 13485: 2016 Dispositivos médicos - Sistemas de gestión de la calidad - requisitos para
fines reglamentarios.
EN ISO 14971: 2012 Dispositivos médicos - Aplicación de la gestión de riesgos a los dispositivos
médicos.
EN ISO 10993-1: 2009 / AC: 2010 Evaluación biológica de dispositivos médicos - Parte 1: Evaluación y prueba
dentro de un proceso de gestión de riesgos.
EN ISO 11135: 2014 Esterilización de productos sanitarios - Óxido de etileno: Requisitos para el
desarrollo, Validación y control rutinario de un proceso de esterilización de
dispositivos médicos.
EN ISO 14644-1: 2015 Salas limpias y ambientes controlados asociados - Parte 1:
Clasificación de la limpieza del aire por concentración de partículas.
EN ISO 14644-2: 2015 Salas limpias y ambientes controlados asociados - Parte 2:
Monitoreo para proporcionar evidencia del desempeño de la sala limpia
relacionado con la limpieza del aire por concentración de partículas.
EN ISO 10993-7: 2008 / AC :2009 Evaluación biológica de dispositivos médicos - Parte 7: Residuos de
esterilización con óxido de etileno.
EN 556-1: 2001 / AC :2006 Esterilización de dispositivos médicos - Requisitos para que los dispositivos
medicos sean designados como "ESTÉRILES" - Parte 1: Requisitos para
dispositivos medicos esterilizados en su estado terminal.
EN ISO 11737-1: 2018 Esterilización de productos sanitarios - Métodos microbiológicos – Parte 1:
Determinación de una población de microorganismos en los productos.
EN 1041: 2008 +A1: 2013 Información proporcionada por el fabricante de dispositivos médicos.
EN ISO 15223-1: 2016 Dispositivos médicos: Símbolos que se utilizarán con las etiquetas de los
dispositivos médicos, el etiquetado y la información que se suministrará.
Parte 1: Requisitos generales.
EN ISO 11607-1: 2009* Envasado para dispositivos médicos esterilizados terminalmente - Parte 1:
Requisitos para materiales, sistemas de barrera estéril y sistemas de
envasado.
EN ISO 11607-2: 2006* Envasado para dispositivos médicos esterilizados terminalmente - Parte 2:
Requisitos de validación para procesos de conformación, sellado y
ensamblado.
Nota:
* indica aplicable únicamente al Evolution Esophageal Stent System.
Página 1 de 2
O’Halloran Road,
Limerick, lreland.
Teléfono: + 353 61 334440
Fax: + 353 61 334441
www.cookmedical.com
Revisado y aprobado por: Fecha:
Asuntos Regulatorios: Megha Bhapkar (DV0001519) 29 de abril de 2020 (DV0001519)
Sistemas de Calidad: Firma obtenida según DV0001519
Microbiólogo Senior: Firma obtenida según DV0001519
Ingeniero Senior de Firma obtenida según DV0001519

Esterilización
Especialista en Firma obtenida según DV0001519

Biocompatibilidad
Ingeniería Firma obtenida según DV0001519
Comunicaciones Clínicas Firma obtenida según DV0001519
Nota: Las firmas de los propietarios de los estándares relevantes indican que se revisaron y aprobaron, para
el pleno cumplimiento de las secciones aplicables de los estándares anteriores.
Página 2 de 2
Date: Thursday 29 April 2021
Certificate Of Analysis
RPN Lot Number Manufacturers Date Expiry Date
EVO-25-30-10-C C1812098 N/A 22 March 2023
EVO-25-30-6-C C1793894 N/A 21 January 2023
EVO-25-30-8-C C1817776 N/A 08 April 2023
EVO-FC-18-23-10-E C1805188 N/A 26 February 2023
EVO-FC-18-23-12-E C1794293 N/A 22 January 2023
EVO-FC-20-25-10-E C1816975 N/A 07 April 2023
EVO-FC-20-25-12-E C1816043 N/A 31 March 2023
EVO-FC-20-25-8-E C1801710 N/A 16 February 2023
Note: The following products/ components are supplied non-sterile:

RPN Sterility and Patient Contacting Information
(C-)HMBL-4-TRI Non-Sterile
(DCB-X-X Non- sterile & non- patient contacting
DT-6-XX Combination of sterile and non-sterile components
RMS-0600XX This is a kit, the kit itself in not sterilised but the components within the kit are sterilised
All the above devices are manufactured by Cook Ireland and shipped to Peru will fulfill the following conditions:
*Sterilization All parameters met Product is sterilized as per the requirements of EN ISO 11135 Sterilisation of
the specification and health care products. Ethylene Oxide- Requirements for development, validation
bacterial growth not and routine control of a sterilization process for medical devices. Product sterility
observed. in every sterilization load is validated to a sterility assurance level (SAL) of 10‾6.
**Toxicity test Negative All patient-contacting materials are screened to be certain that they have an
established history of use in patient-contacting medical devices and they are
tested as deemed necessary. Biocompatibility testing for patient contacting
material is based on the material, its intended application and duration of use.
This may include USP Class VI testing or more extensive tests, as per EN
ISO10993-1 Biological Evaluation of Medical Devices- part 1: Evaluation and
testing within a risk management process.
*EO Residual Test Passed All products meet the requirements of EN ISO10993-7 Biological Evaluation of
Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.
Function and Passed Function and qualification tests are dependent upon the particular function of
Qualification Test each individual device. Critical functions are determined and each device lot is
tested for functionality as required per procedure. Testing is performed by trained
production and quality control inspectors as per Cook Ireland Limited procedures.
Final Inspection Passed Final inspection procedures are individually designed to fit the design being
inspected. Each device lot is evaluated before the lot accepted. Testing is
performed by trained production and quality control inspectors per Cook Ireland
Limited procedures.
Registration Cook Ireland’s quality management system has been approved by TUV Product
Service to the quality management system standards EN ISO 13485.
* Applies to sterile products.
https://portalemea.cookgroup.nao/regscert/Products?type=COA&id=2261&handler=GetLots 1/2
Date: Thursday 29 April 2021
Certificate Of Analysis
** Applies to patient contacting parts only.
We at Cook Ireland hereby declare that to the best of our knowledge, that the information contained in this Certificate of Analysis is
truthful and accurate.
https://portalemea.cookgroup.nao/regscert/Products?type=COA&id=2261&handler=GetLots 2/2
Traducción Simple
Fecha: Jueves 29 de abril de 2021
CERTIFICADO DE ANÁLISIS
RPN Número de Lote Fecha de Fecha de vencimiento

Fabricación
EVO-25-30-10-C C1812098 N/A 22 de marzo de 2023
EVO-25-30-6-C C1793894 N/A 21 de enero de 2023
EVO-25-30-8-C C1817776 N/A 8 de abril de 2023
EVO-FC-18-23-10-E C1805188 N/A 26 de febrero de2023
EVO-FC-18-23-12-E C1794293 N/A 22 de enero de 2023
EVO-FC-20-25-10-E C1816975 N/A 07 de abril 2023
EVO-FC-20-25-12-E C1816043 N/A 31 de marzo de 2023
EVO-FC-20-25-8-E C1801710 N/A 16 de febrero de 2023
Nota: Los siguientes productos/componentes se suministran sin esterilizar:
RPN Información sobre esterilidad y contacto con el paciente

(C-)HMBL-4-TRI No estéril
(DCB-X-X No estéril y sin contacto con el paciente
DT-6-XX Combinación de componentes estériles y no estériles
RMS-0600XX Se trata de un kit, el kit en sí no está esterilizado, pero los

componentes que contiene están esterilizados.
Todos los dispositivos mencionados son fabricados por Cook Ireland y enviados a Perú
cumplirán las siguientes condiciones
*Esterilización Todos los parámetros El producto está
cumplen la especificación esterilizado según los
y no se observa requisitos de la norma EN
crecimiento bacteriano. ISO 11135 Esterilización
de productos sanitarios.
Óxido de etileno-
Requisitos para el
desarrollo, la validación y
el control rutinario de un
proceso de esterilización
para dispositivos médicos.
La esterilidad del producto
en cada carga de
esterilización se valida
hasta un nivel de garantía
de esterilidad (SAL) del
10‾6.
**Prueba de toxicidad Negativo Todos los materiales en
contacto con el paciente se
examinan para asegurarse
de que tienen un historial
establecido de uso en
dispositivos médicos en
contacto con el paciente y
se someten a las pruebas
que se consideren
necesarias. Las pruebas de
biocompatibilidad para el
material en contacto con el
paciente se basan en el
material, su aplicación
prevista y la duración del
uso.
Esto puede incluir pruebas
de la clase VI de la USP o
pruebas más amplias,
según la norma EN
ISO10993-1 Evaluación
biológica de los
dispositivos médicos -
parte 1: Evaluación y
pruebas dentro de un
proceso de gestión de
riesgos.
*Prueba de residuos de Aprobado Todos los productos
EO cumplen los requisitos de
la norma EN ISO10993-7
Evaluación biológica de
dispositivos médicos -
Parte 7: Residuos de
esterilización por óxido de
etileno.
Prueba de Aprobado Las pruebas de
funcionamiento y funcionamiento y
cualificación cualificación dependen de
la función particular de
cada dispositivo
individual. Se determinan
las funciones críticas y se
comprueba la
funcionalidad de cada lote
de dispositivos según el
procedimiento. Las
pruebas son realizadas por
inspectores de producción
y control de calidad
formados según los
procedimientos de Cook
Ireland Limited.
Inspección final Aprobado Los procedimientos de
inspección final se diseñan
individualmente para
adaptarse al diseño que se
inspecciona. Cada lote de
dispositivos se evalúa
antes de aceptar el lote.
Las pruebas son realizadas
por inspectores de
producción y de control de
calidad capacitados según
los procedimientos de
Cook Ireland Limited.
Registro El sistema de gestión de la
calidad de Cook Ireland ha
sido aprobado por TÜV
Product Service según las
normas del sistema de
gestión de la calidad EN
ISO 13485
* Se aplica a productos estériles.
** Se aplica sólo a las piezas en contacto con el paciente.
Nosotros, en Cook Ireland, declaramos por la presente que, la información contenida en

este Certificado de Análisis es veraz y exacta.
_______________________
Ingeniero de esterilización
___________________________
Especialista en biocompatibilidad
Sterilization
Document Number: Revision: QMS Owner: Page:
D00173606 001 Cook Ireland Ltd. 1 of 10
Title: Sterilisation Validation Report for the Cook Ireland Routine Cycle on lines 8 & 9
Legacy Number: N/A
PROCESS VALIDATION FORM TYPE: √ Tick Relevant
OPERATIONAL QUALIFICATION (OQ)
PRODUCT PERFORMANCE QUALIFICATION (PPQ)
MICROBIOLOGICAL PERFORMANCE QUALIFICATION (MPQ)
REVALIDATION √
OTHER (specify): _____________________________________

_________________________________________________________________________
Section 1: Table of Contents

Section 2 Scope 01
Section 3: Summary 01
Section 4: Reference Documents 02
Section 5: Deviations to Protocol 02
Section 6: Results 02
Section 7: Residual testing 09
Section 8: Product Quality testing 10
Section 9: Training Requirements 10
Section 10: Conclusion 10
Section 11: Support Documents 10
Section 12: Validation Product/Sub assembly Scope 10
Section 13: Legacy Version History 10
Section 2: Scope
The successful execution of this validation has served to validate the routine cycle products using the
ethylene oxide contract sterilisation process as per I-CSP-023, QSI094101, WI-QA-022, and
ISO11135:2014 (Sterilisation of Healthcare products- ethylene oxide: requirements for the
development, validation and routine control of a sterilisation process for medical devices) and was
performed by Synergy Health Ireland. This revalidation only applies to the Cook Ireland Routine
Sterilisation cycle on lines 8 & 9 at Synergy Health Ireland.
Section 3: Summary
This validation consisted of the following:
1. An empty chamber profile (operational qualification) which successfully demonstrated that the
installed equipment is capable of meeting its operating specification.
2. A half cycle/product profile (Microbiological/Physical performance Qualification) on the
maximum density load. This cycle demonstrated that the specified acceptance criteria has been
met throughout the load for the duration of the process and that on the application of the
sterilisation process the specified requirements for sterility have been met i.e. has demonstrated
that the process has an SAL of 10-6.
3. A half cycle/product profile (Microbiological/Physical performance Qualification) on the
minimum density load. This cycle demonstrated that the specified acceptance criteria has been
met throughout the load for the duration of the process and that on the application of the
WARNING CONFIDENTIAL PROPRIETARY PROPERTY - This document is owned by COOK Medical. It contains confidential proprietary trade secret information and must not be copied. The
document and the information it contains can be used only by the recipient for the specific use for which it was requested. All other use is strictly prohibited. This document must be returned to COOK
Medical immediately upon request by COOK Medical. By possession of this document, the possessor expressly agrees to comply with these terms.
“© COPYRIGHT Cook Ireland Ltd. 2017“
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
sterilisation process the specified requirements for sterility have been met i.e. has demonstrated
that the process has an SAL of 10-6.
Section 4: Reference Documents

Table 1: Reference Documents
Document Number Title
D00059974 (QSI3201) Microbiology Assessment Procedure
D00059737 (QSI094101) Sterilisation Validation procedure
ISO11135: 2014 Sterilisation of Healthcare products- ethylene oxide: requirements
for the development, validation and routine control of a sterilisation
process for medical devices
ISO10993-7:2008 Biological evaluation of medical devices Part 7: ethylene oxide
sterilisation residuals
WI-QA-022 Synergy Health Sterilisation Validation Procedure
I-ISI-994 Synergy Health Revalidation Protocol
RC 17/ 08/003 Rev 0 Synergy Health Change Request
I-CSP-023 Cook Ireland Cycle Specification products for lines 8 & 9 at
Synergy Health Tullamore.
VAL10-0022 Cross line Validation of Cook Irelands products on line # 8
VAL07-0002 Validation of Cook Ireland products on line # 9
VAL07-0078 Validation for the EtO gas sterilisation of Cook Ireland SEMS
products and the New metal cage configuration on line # 9 at Isotron
(Synergy Health)
CHT0255 Sterilisation Master Validation Report
VAL16-0036 Re-validation of Cook Irelands Routine sterilisation cycle 2016.
D00171765 Requalification Protocol for CIRL routine sterilisation cycle on lines
8&9
Section 5: Deviations to protocol

There were no deviations to the protocol during this validation study.
Section 6: Results
Section 6.1 Data Summary
Table 2: OQ acceptance Criteria and Results – Empty Chamber profile batch # 11978648
Time of Accepted tolerance Actual Result
Phase Parameter
measurement (data logger average)
Process average: 40.75°C

During Steady +/- 5°C of process
Temperature +/-5°C: 35.75° - 45.75°C
Pre- State average
conditioning Actual : 40.12-41.91°C
phase
During Steady +/- 15% of process Process average: 57.45%
RH
State average +/-15%: 42.45 -72.45%
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
Actual : 53.1-60.5%
Conditioning 34.90°C - 36.94°C

Temperature (start of last Information only
steam injection)
Conditioning 42.5% – 48.8%

RH (start of last Information only
steam injection)
Sterilisation
phase Process average : 41.20°C
Conditioning
+/- 5°C of process
Temperature (at end of steam +/-5°C :36.20 - 46.20°C
average
dwell)
Actual : 41.05-43.39°C
Conditioning >30%
RH (at end of steam >30%
dwell)
Process average: 40.6°C +/-3°C:

Exposure +/- 3°C of process 37.6°C to 43.6°C
Temperature Exposure phase
Phase average
Actual : 40.36-42.52°C
Process average : 40.0°C

+/- 5°C of process
Degassing Temperature Steady State +/-5°C:35.0°C -45.0°C
average
Actual : 37.16 - 38.76°C
Table 3: Microbiological Qualification Acceptance Criteria and Results - minimum density batch #
11988577
Cycle Acceptance criteria Actual Result
Half cycle  All process parameters must be  All process parameters were within
within specification per the specification as per the applicable PRS.
applicable PRS.
 There were no positive biological
 There must be no positive BI’s
indicators recovered in either the
recovered in either the internal or
internal or the external PCD’s.
external PCDs.
 The positive control BI’s must test
positive.  The positive control tested positive.
 All test units must be put on test
within the timelines specified in the  All test units were placed on test within
Synergy Health protocol (ref section the timelines specified in the protocol.
9.3 of I-ISI-994 support document 5).
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
Table 4: Microbiological Qualification Acceptance Criteria and Results - maximum density 11993801
Cycle Acceptance criteria Actual Result
Half cycle  All process parameters must be  All process parameters were within
within specification per the specification as per the applicable PRS.
applicable PRS.
 There were no positive biological
 There must be no positive BI’s
indicators recovered in either the
recovered in either the internal or
internal or the external PCD’s.
external PCDs.
 The positive control BI’s must test
positive.  The positive control tested positive.
 All test units must be put on test
within the timelines specified in the  54/55 of the external PCD were tested
Synergy Health protocol (ref section within the timeline specified. One
9.3 of I-ISI-994 support document 5). EPCD was not recovered from the load
in time for testing ( see section 6.2). All
other units were placed on test within
the timelines specified in the protocol
Table 5: Physical Performance Qualification Acceptance Criteria and results- Half Cycle- minimum
density Batch # 11988577
Accepted Actual Results

Time of tolerance
Phase Parameter
measurement (data logger
average)
Pre- Temperature During Steady State 25-45°C 30.15°C - 40.69°C

conditioning
phase RH During Steady State 30 – 80 % 41.8-56.3%
Transfer of product to 96 mins

Transfer time ≥1 hour
sterilisation chamber
 The vacuum time and the holding time  The vacuum time and the holding time
under vacuum must be defined in the under vacuum are defined in the cycle
cycle specification and the parameters specification and the parameters were
Leak Testing
must be met during the PPQ cycles. met during the PPQ cycles.
and nitrogen
gas flushing  The pressure increment and the rate of  The pressure increment and the rate of
attainment of pressure associated with attainment of pressure associated with
nitrogen or steam must be defined in the nitrogen or steam were defined in the
cycle specification and the parameters cycle specification and the parameters
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
must be met during the PPQ cycles. were met during the PPQ cycles.
 The pressure depth and the rate of  The pressure depth and the rate of
achieving the vacuums must be defined achieving the vacuums were defined in
in the cycle specification and the the cycle specification and the
parameters must be met during the parameters were met during the PPQ
PPQ cycles. cycles.
 The number of repetitions and the  The number of repetitions and the
variation in any repetitions must be variation in any repetitions were
defined in the cycle specification and defined in the cycle specification and
the parameters must be met during the the parameters were met during the
PPQ cycles PPQ cycles
Conditioning (at end 37.82°C -41.73°C

Temperature 20 -45°C
of steam dwell)
Conditioning (at end 77.0%-89.1%

RH >30%
of steam dwell)
 The pressure levels and the rate of  The pressure levels and the rate of
attainment of vacuums or RH levels attainment of vacuums were defined in
must be defined in the cycle the cycle specification and the
specification and the parameters must parameters were met during the PPQ
be met during the PPQ cycles cycles
 The number of steam pulses must be  The number of steam pulses was
PPQ cycles. PPQ cycles.
 The total time for the conditioning  The total time for the conditioning
Conditioning
phase must be defined in the cycle phase were defined in the cycle
phase/end of
specification and the parameters must specification and the parameters were
steam dwell
be met during the PPQ cycles met during the PPQ cycles
 The chamber temperature during  The chamber temperature during
conditioning must be defined in the conditioning were defined in the cycle
cycle specification and the parameters specification and the parameters were
must be met during the PPQ cycles met during the PPQ cycles
 The temperature and humidity of the  The temperature and humidity of the
load at the end of conditioning must be load at the end of conditioning were
PPQ cycles PPQ cycles
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
Temperature Exposure phase 20-45°C 38.88°C - 41.33°C
 The EO injection pressure, time • The EO injection pressure, time were

must be defined in the cycle defined in the cycle specification and the
specification and the parameters parameters were met during the PPQ cycles
must be met during the PPQ
Exposure
cycles
Phase
Evidence Gas weight Gas Weight – 69kg
that EO gas verification, EO pressure rise as above
was admitted Exposure phase pressure rise
to the
chamber
 The depth and rate of vacuums were
 The depth and rate of vacuums must
defined in the cycle specification and
be defined in the cycle specification
the parameters were met during the
and the parameters must be met during
PPQ cycles
the PPQ cycles
 The depth and rate of pressures
 The depth and rate of pressures
Post Exposure associated with air and nitrogen
associated with air and nitrogen
Flushing washes were defined and parameters
washes
were met during the PPQ cycle
 The number of repetitions of washes
 The number of repetitions of washes
must be defined in the cycle
were defined in the cycle specification
specification and the parameters must
and the parameters were met during
be met during the PPQ cycles
the PPQ cycles
The time and temperature within the The time and temperature within the
aeration room must be defined in the aeration room were defined in the cycle
Degassing (if cycle specification and the parameters specification and the parameters were met
applicable) must be met during the PPQ cycles during the PPQ cycles
Temperature Steady State 15- 45°C 38.31 - 38-57 °C
Table 6: Physical Performance Qualification Acceptance Criteria and results- Half Cycle- maximum
density Batch # 11993801
Accepted Actual Results

tolerance
Phase Parameter Time of measurement
(data logger
average)
Pre-conditioning Temperature During Steady State 25-45°C 36.26-41.46°C
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
phase
47.9-81.8% (ref to
RH During Steady State 30 – 80 %
section 6..2)
Transfer of product to 67mins

Transfer time ≥1 hour
sterilisation chamber
 The vacuum time and the holding  The vacuum time and the holding time
time under vacuum must be defined under vacuum were defined in the cycle
in the cycle specification and the specification and the parameters were
parameters must be met during the met during the PPQ cycles.
PPQ cycles.
 The pressure increment and the rate of
 The pressure increment and the rate attainment of pressure associated with
of attainment of pressure associated nitrogen or steam were defined in the
with nitrogen or steam must be cycle specification and the parameters
defined in the cycle specification were met during the PPQ cycles.
and the parameters must be met
Leak Testing and  The pressure depth and the rate of
nitrogen gas during the PPQ cycles.
achieving the vacuums were defined in
flushing  The pressure depth and the rate of the cycle specification and the
achieving the vacuums must be parameters were met during the PPQ
defined in the cycle specification cycles.
 The number of repetitions and the
during the PPQ cycles.
variation in any repetitions were
 The number of repetitions and the defined in the cycle specification and
variation in any repetitions must be the parameters were met during the
defined in the cycle specification PPQ cycles
during the PPQ cycles
Conditioning (at end of 37.82 - 41.37°C

Temperature 20 -45°C
steam dwell)
Conditioning (at end of 85.2 - 92.1%

RH >30%
steam dwell)
 The pressure levels and the rate of  The pressure levels and the rate of
attainment of vacuums or RH levels attainment of vacuums were defined in
must be defined in the cycle the cycle specification and the
Conditioning
specification and the parameters parameters were met during the PPQ
phase/end of
must be met during the PPQ cycles cycles
steam dwell
 The number of steam pulses must  The number of steam pulses was
be defined in the cycle specification defined in the cycle specification and
and the parameters must be met the parameters were met during the
during the PPQ cycles. PPQ cycles.
 The total time for the conditioning  The total time for the conditioning
phase must be defined in the cycle phase were defined in the cycle
specification and the parameters specification and the parameters were
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
 The chamber temperature during  The chamber temperature during

conditioning must be defined in the conditioning were defined in the cycle
cycle specification and the specification and the parameters were
parameters must be met during the met during the PPQ cycles
PPQ cycles
 The temperature and humidity of the
 The temperature and humidity of load at the end of conditioning were
the load at the end of conditioning defined in the cycle specification and
must be defined in the cycle the parameters were met during the
specification and the parameters PPQ cycles
must be met during the PPQ cycles
39.94 -
Temperature Exposure phase 20-45°C
42°C
 The EO injection pressure, time

 The EO injection pressure, time must be
were defined in the cycle
defined in the cycle specification and the
specification and the
parameters must be met during the PPQ
parameters were met during the
cycles
Exposure Phase PPQ cycles
Gas Weigh - 60kg

Gas weight
Evidence that EO verification,
gas was admitted Exposure phase pressure rise Pressure – 550mbar
to the chamber
Spec( 531-
565mbars)
 The depth and rate of vacuums  The depth and rate of vacuums were
must be defined in the cycle defined in the cycle specification and
specification and the parameters the parameters were met during the
must be met during the PPQ cycles PPQ cycles
 The depth and rate of pressures  The depth and rate of pressures
associated with air and nitrogen associated with air and nitrogen
Post Exposure
washes must be defined in the cycle washes were defined in the cycle
Flushing
specification and the parameters specification and the parameters were
 The number of repetitions of  The number of repetitions of washes
washes must be defined in the cycle were defined in the cycle specification
specification and the parameters and the parameters were met during
must be met during the PPQ cycles the PPQ cycles
The time and temperature within the The time and temperature within the
aeration room must be defined in the aeration room were defined in the cycle
Degassing (if cycle specification and the parameters specification and the parameters must were
applicable) must be met during the PPQ cycles. during the PPQ cycles.
Temperature Steady State 15- 45°C 37.82-38.75°C
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
Section 6.2 Non-Conformities and Investigation Results.
1. During the MPQ/PPQ for the maximum density loads, Batch # 11993801 external PCD #29 was
not tested as it was not recovered from the load within the specified time. As per section 8.1 of I-
ISI-994, D00171765-Rev001-Support5, the number of Biological indicators required for testing is
based on the load volume of the chamber being used as per the guidance in annex C of
ISO11135:2014; in addition two (2) extra Biological indicators are added as a safety margin.
Therefore, this has no impact on the outcome of the validation as the minimum quantity of
biological indicators was used and no action was required.
2. In D00173606-Rev001Support4- product profile acceptance criteria, the load humidity exceeded

the tentative value set. For the product profile, attributes that are not directly controlled are
designated with a tentative, expected value that will be reviewed, confirmed or revised (as
required) in conjunction with the process performance data and microbiological results. The
maximum specification for the load humidity was 80% and the actual value achieved was 81.8%.
The actual value recorded will have no impact to the validation as the purpose of humidity during
the pre-conditioning phase is to ensure that the BI’s are re-activated and to condition the product
to allow for the penetration of the EO gas. In addition, during the sterilisation phase, the
requirement is that the RH be greater than 30% with no maximum specification. This has no
impact on the outcome of the validation and therefore no action is required.
Section 6.3 Errors and How Addressed

In protocol D00171765-Rev001-Support1, the product profile acceptance criteria, it the following
documentation errors were noted:
1. Transfer time from pre-conditioning to sterilisation: The specification on support #1 stated a

maximum of 60 mins; this should be a minimum of 60mins as the routine specification is
maximum of 60mins. During the half cycle, the transfer time must be at 60mins minimum to
demonstrate worst case during routine processing.
Note: The OQ was run on a routine full cycle and therefore the transfer time must have been
less than 60mins.
2. Gas Exposure time: the specification stated that the time was 7hrs to 7hrs 30 mins; this should
be 3hrs 30mins maximum.
As per section 12 of protocol D00171765 the Product Profile were carried out as part of the half
cycles. The specifications in support document # 1 of protocol D00171765 were not adjusted for the
half cycle requirements as per the half cycle PRS25806. The cycle were carried out as per the
requirements of the protocol and the PRS and the errors noted above have no impact on the outcome
of the validation as they were just documentation errors.
Section 7: Residual Testing

Residual testing was not out as part of this validation. Residual testing has been carried out for all
products, details can be found in the relevant section of the Technical files associated with each
product family
Template: F094101D (R021, C00002708)

Sterilization
Legacy Number: N/A
Section 8: Product Quality Testing

Product quality testing was not carried out as part of this validation. The product quality testing has
been carried out for all products and details of all testing carried out can be found in the relevant
sections of the technical file associated with each product family.
Section 9: Training Requirements

9.1 The validation was executed by the contract facility Synergy Health Ireland Limited. Synergy
Health carried out the validation as per the protocol on support document 5 of protocol
D00171765 and was responsible for any training requirements.
9.2 No training requirements were required by CIRL as part of this validation.
Section 10: Conclusion

Based on the results of the OQ and MPQ/PPQ, the Cook Ireland routine cycle on lines 8&9 at Synergy
Health Ireland has been successfully requalified.
Template: F094101D (R021, C00002708)

Esterilización
Número de documento : Revisión: Propietario de SGC : Página:
D00173606 001 Cook Irlanda Ltd. 1 de 10
Título: Informe de validación de esterilización para el ciclo de rutina de Cook Ireland en las líneas 8 y 9
Número heredado: N/A
TIPO DE FORMULARIO DE VALIDACIÓN DEL PROCESO : √ Marque lo que corresponda
CALIFICACIÓN OPERATIVA (CO)
CALIFICACIÓN DEL RENDIMIENTO DEL PRODUCTO (CRP)
CALIFICACIÓN DEL RENDIMIENTO MICROBIOLÓGICO (CRM)
REVALIDACIÓN √
OTROS (especificar):
Sección 1: Índice de contenidos

Sección 2: Ámbito de aplicación 01
Sección 3: Resumen 01
Sección 4: Documentos de referencia 02
Sección 5: Desviaciones del producto 02
Sección 6: Resultados 02
Sección 7: Pruebas residuales 09
Sección 8: Pruebas de calidad del producto 10
Sección 9: Requisitos de formación 10
Sección 10: Conclusión 10
Sección 11: Documentos de apoyo 10
Sección 12: Alcance del producto/subconjunto de validación 10
Sección 13: Historial de versiones anteriores 10
Sección 2: Ámbito de aplicación

La ejecución exitosa de esta validación ha servido para validar los productos de ciclo de rutina
utilizando el proceso de esterilización por contrato de óxido de etileno según I-CSP-023,
QSI094101, WI-QA-022 e ISO11135: 2014 (Esterilización de Productos sanitarios - óxido de etileno:
requisitos para el desarrollo, validación y control rutinario de un proceso de esterilización para
dispositivos médicos) y fue realizado por Synergy Health Ireland. Esta revalidación solo se aplica al
ciclo de esterilización de rutina de Cook Ireland en las líneas 8 y 9 de Synergy Health Ireland.
Sección 3: Resumen
Esta validación consistió en lo siguiente:
1. Un perfil de cámara vacía (calificación operativa) que demostró con éxito que el equipo
instalado es capaz de cumplir con sus especificaciones de funcionamiento.
2. Un medio ciclo/perfil producto (Calificación de rendimiento microbiológico/físico) sobre la
carga de máxima densidad. Este ciclo demostró que los criterios de aceptación especificados
se han cumplido durante toda la carga durante la duración del proceso y que en la aplicación
del proceso de esterilización el especificado se han cumplido los requisitos de esterilidad, es
Formato: F094101D (R021, C00002708)

Esterilización
Número de documento : Revisión: Propietario de SGC : Página:
decir, se ha demostrado que el proceso tiene un SAL de 10-6.

3. Un medio ciclo/perfil del producto (Calificación de rendimiento microbiológico/físico) en la
carga de densidad mínima. Este ciclo demostró que los criterios de aceptación especificados se
han cumplido en toda la carga durante la duración del proceso y que en la aplicación del
proceso de esterilización se han cumplido los requisitos especificados para la esterilidad, es
decir ha demostrado que el proceso tiene una SAL de 10-6
Sección 4: Documentos de referencia

Cuadro 1: Documentos de referencia
Número de documento Título
D00059974 (QSI3201) Procedimiento de evaluación de microbiología
D00059737 (QSI094101) Procedimiento de validación de esterilización
ISO11135: 2014 Esterilización de productos sanitarios- óxido de etileno: requisitos
para el desarrollo, validación y control rutinario de un proceso de
esterilización de productos sanitarios
ISO10993-7:2008 Evaluación biológica de productos sanitarios Parte 7: Residuos
de esterilización de óxido de etileno
WI-QA-022 Procedimiento de validación de esterilización de Synergy Health
I-ISI-994 Protocolo de revalidación de Synergy Health
RC 17/08/003 Rev 0 Solicitud de cambio de Synergy Health
I-CSP-023 Productos Cook Ireland Cycle Specification para las líneas
8 y 9 en Synergy Health Tullamore.
VAL10-0022 Validación cruzada de productos Cook Irelands en la línea # 8
VAL07-0002 Validación de productos Cook Ireland en línea # 9
VAL07-0078 Validación para la esterilización de gas EtO de productos SEMS de
Cook Ireland y la nueva configuración de jaula metálica en la línea #
9 en Isotron (Synergy Health)
CHT0255 Informe de validación del maestro de esterilización
VAL16-0036 Revalidación del ciclo de esterilización de Cook Irelands Routine
D00171765 2016.
Protocolo de recalificación para el ciclo de esterilización rutinaria
CIRL en las líneas 8 y 9
Sección 5: Desviaciones del protocolo

No hubo desviaciones en el protocolo durante este estudio de validación.
Sección 6: Resultados
Sección 6.1 Resumen de datos
Tabla 2: Criterios y resultados de aceptación de OQ – Lote de perfil de cámara vacía # 11978648

Tiempo de Tolerancia aceptada Resultado real
Fase Parámetro
medición (promedio del
registrador de datos)
Fase de Promedio del proceso: 40.75°C
preacondicio Durante el +/- 5°C del
Temperatura +/-5°C: 35.75° - 45.75°C
namiento estado promedio del
estacionario proceso Real: 40.12-41.91°C
Formato: F094101D (R021, C00002708)

Durante el +/- 15% del Promedio del proceso: 57.45%
Rh
estado promedio del +/-15%: 42,45 -72,45%
estacionario proceso
Acondicionami 34.90°C - 36.94°C

Temperatura ento (inicio de Sólo información
la última
inyección de
vapor)
Acondicionami 42.5% – 48.8%
Fase de Rh ento (inicio de Sólo información
esterilizació la última
n inyección de
vapor)
Promedio del proceso : 41.20°C

Acondicionami
+/- 5°C de
Temperatura ento (al final de +/-5°C : 36.20 -
promedio del
la morada de
proceso 46.20°C Actual : 41.05-
vapor)
43.39°C
Acondicionami >30%
Rh ento (al final de >30%
la morada de
vapor)
Fase de +/- 3°C de +/-3°C: 37.6°C a 43.6°C
Temperatura Fase de
exposició promedio del
exposición Actual : 40.36-42.52°C
n proceso
+/- 5°C de
Desgasificació Temperatura Estado +/-5°C:35.0°C -45.0°C
promedio del
n estacionario
proceso Actual : 37.16 - 38.76°C
Formato: F094101D (R021, C00002708)

Tabla 3: Criterios y resultados de aceptación de la calificación microbiológica - lote de densidad
mínima # 11988577
Ciclo Criterios de aceptación Resultado real
Medio ciclo • Todos los parámetros del • Todos los parámetros del proceso
proceso deben estar dentro de estaban dentro de las especificaciones
las especificaciones según el según el PRS aplicable.
PRS aplicable.
• No se recuperaron indicadores
• No debe haber BI positivos
biológicos positivos ni en los
recuperados en los PCD internos
PCD internos ni externos.
o externos.
• Los BI de control positivo deben
probar • El control positivo dio positivo.
Positivo.
• Todas las unidades de prueba se
• Todas las unidades de ensayo
pusieron a prueba dentro de los plazos
deben someterse a prueba dentro
especificados en el protocolo.
de los plazos especificados en el
protocolo Synergy Health (sección
de referencia)
9.3 del documento de apoyo 5 de la
I-ISI-994).
Formato: F094101D (R021, C00002708)

Esterilización
Número de documento : Revisión: Propietario de QMS : Página:
Tabla 4: Criterios y resultados de aceptación de la calificación microbiológica - densidad máxima 11993801
Ciclo Criterios de aceptación Resultado real
Medio ciclo • Todos los parámetros del • Todos los parámetros del proceso
proceso deben estar dentro de estaban dentro de las especificaciones
las especificaciones según el según el PRS aplicable.
PRS aplicable.
• No se recuperaron indicadores
• No debe haber BI positivos
biológicos positivos ni en los
recuperados en los PCD internos
PCD internos ni externos.
o externos.
• Los BI de control positivo deben
probar • El control positivo dio positivo.
Positivo.
• 54/55 de los PCD externos se probaron
• Todas las unidades de ensayo
dentro del plazo especificado. No se
deben someterse a prueba dentro
recuperó una EPCD de la carga a
de los plazos especificados en el
tiempo para la prueba (ver sección
protocolo Synergy Health (sección
6.2). Todas las demás unidades se
de referencia)
pusieron a prueba dentro de los plazos
9.3 del documento de apoyo 5 de la
especificados en el protocolo.
I-ISI-994).
Tabla 5: Criterios y resultados de aceptación de la calificación del rendimiento físico - Medio ciclo-
densidad mínima Lote # 11988577
Tolerancia Resultados reales

Tiempo de aceptada
Fase Parámetro
medición (promedio
del
registrador
Fase de Temperatura Durante el estado 25-45°C
de datos) 30.15°C - 40.69°C
preacondicio estacionario
namiento Rh Durante el estado 30 – 80 % 41.8-56.3%
estacionario
Transferencia del 96 minutos
Tiempo de ≥1 hora
producto a la cámara
transferencia
de esterilización
• El tiempo de vacío y el tiempo de • El tiempo de vacío y el tiempo de
retención bajo vacío deben definirse retención bajo vacío se definen en la
Pruebas de en la especificación del ciclo y los especificación del ciclo y los
fugas y parámetros deben cumplirse durante parámetros se cumplieron durante los
lavado de gas los ciclos PPQ. ciclos PPQ.
nitrógeno • El incremento de presión y la tasa de • El incremento de presión y la tasa de
logro de la presión asociada con el logro de la presión asociada con el
nitrógeno o el vapor deben definirse en nitrógeno o el vapor se definieron en
la especificación del ciclo y en los la especificación del ciclo y los
parámetros. parámetros.
Formato: F094101D (R021, C00002708)

Esterilización
debe cumplirse durante los ciclos ppq. se cumplieron durante los ciclos ppq.
• La profundidad de la presión y la • La profundidad de la presión y la
velocidad de logro de los vacíos deben velocidad de logro de los vacíos se
definirse en la especificación del ciclo definieron en la especificación del
y los parámetros deben cumplirse ciclo y los parámetros se cumplieron
durante los ciclos PPQ. durante los ciclos PPQ.
• El número de repeticiones y la • El número de repeticiones y la
variación en cualquier repetición variación en cualquier repetición se
deben definirse en la especificación definieron en la especificación del
del ciclo y los parámetros deben ciclo y los parámetros se cumplieron
cumplirse durante los ciclos PPQ. durante los ciclos PPQ.
Acondicionamiento 37.82°C -41.73°C
Temperatura 20 -45°C
(al final de la
morada de vapor)
Acondicionamiento 77.0%-89.1%
Rh >30%
(al final de la
morada de vapor)
• Los niveles de presión y la tasa de • Los niveles de presión y la tasa de
logro de vacíos o niveles de HR logro de vacíos se definieron en la
deben definirse en la especificación especificación del ciclo y los
del ciclo y los parámetros deben parámetros se cumplieron durante los
cumplirse durante los ciclos PPQ. ciclos PPQ.
• El número de pulsos de vapor debe • El número de pulsos de vapor se
definirse en la especificación del definió en la especificación del ciclo
ciclo y los parámetros deben y los parámetros se cumplieron
Fase de • El tiempo total para la fase de • El tiempo total para la fase de
acondiciona acondicionamiento debe definirse acondicionamiento se definió en la
miento/fin en la especificación del ciclo y los especificación del ciclo y los
de la morada parámetros deben cumplirse parámetros se cumplieron durante
de vapor durante los ciclos PPQ los ciclos PPQ.
• La temperatura de la cámara durante • La temperatura de la cámara durante
el acondicionamiento debe definirse el acondicionamiento se definió en
en la especificación del ciclo y los la especificación del ciclo y los
parámetros deben cumplirse parámetros se cumplieron durante los
durante los ciclos PPQ. ciclos PPQ
• La temperatura y la humedad de la • La temperatura y la humedad de la
carga al final del acondicionamiento carga al final del acondicionamiento
deben definirse en la especificación se definieron en la especificación
del ciclo y los parámetros deben del ciclo y los parámetros se
cumplirse durante los ciclos PPQ. cumplieron durante los ciclos PPQ.
Formato: F094101D (R021, C00002708)

Esterilización
Temperatura Fase de exposición 20-45°C 38.88°C - 41.33°C
• La presión de inyección EO, el • La presión de inyección de EO, el tiempo

tiempo debe definirse en la se definieron en la especificación del
especificación del ciclo y los ciclo y los parámetros se cumplieron
Fase de parámetros deben cumplirse durante los ciclos PPQ
exposició durante los ciclos PPQ
n Evidencia de Peso del gas – 69kg
Verificación
que el gas del peso del Aumento de la presión de EO
EO fue Fase de exposición gas, como se indica arriba
admitido en aumento de
la cámara la presión
• La profundidad y la velocidad de los
• La profundidad y la velocidad de los
vacíos se definieron en la
vacíos deben definirse en la
especificación del ciclo y los
parámetros se cumplieron durante
parámetros deben cumplirse durante
los ciclos PPQ.
los ciclos PPQ.
Enrojecimient • Se definió la profundidad y la
• La profundidad y la velocidad
o posterior a velocidad de las presiones asociadas
de las presiones asociadas con
la exposición con los lavados de aire y nitrógeno
los lavados de aire y nitrógeno
y se cumplieron los parámetros
• El número de repeticiones de lavados
durante el ciclo PPQ.
debe definirse en la especificación
• El número de repeticiones de lavados
del ciclo y los parámetros deben
se definió en la especificación del
cumplirse durante los ciclos PPQ.
El tiempo y la temperatura dentro de ciclo yy los
El tiempo parámetros dentro
la temperatura se cumplieron
de la
la sala de aireación deben definirse durante los ciclos PPQ.
sala de aireación se definieron en la
Desgasificaci en la especificación del ciclo y los especificación del ciclo y los parámetros
ón (si parámetros deben cumplirse se cumplieron durante los ciclos PPQ.
corresponde) durante los ciclos PPQ.
Temperatura Estado 15- 45°C 38.31 - 38-57 °C
estacionario
Tabla 6: Criterios y resultados de aceptación de la calificación del rendimiento físico - Medio ciclo-
densidad máxima Lote # 11993801
Tolerancia Resultados reales

aceptada
Fase Parámetro Tiempo de medición
(promedio
del
registrador
Preacondicionamie Temperatura Durante el estado 25-45°C
de datos) 36,26 a 41,46 °C
nto estacionario
Formato: F094101D (R021, C00002708)

Esterilización
fase
47.9-81.8% (ref a
Rh Durante el estado 30 – 80 %
sección 6.. 2)
estacionario
Transferencia del 67 minutos
Tiempo de ≥1 hora
producto a la cámara
transferencia
de esterilización
• El tiempo de vacío y el tiempo de • El tiempo de vacío y el tiempo de
retención bajo vacío deben retención bajo vacío se definieron en
definirse en la especificación del la especificación del ciclo y los
ciclo y los parámetros deben parámetros se cumplieron durante los
• El incremento de presión y la tasa • El incremento de presión y la tasa de
de logro de la presión asociada con logro de la presión asociada con el
el nitrógeno o el vapor deben nitrógeno o el vapor se definieron en
Pruebas de fugas ciclo y los parámetros deben parámetros se cumplieron durante los
y lavado de gas cumplirse durante el Ciclos PPQ. ciclos PPQ.
nitrógeno
• La profundidad de la presión y la • La profundidad de la presión y la
velocidad de logro de los vacíos velocidad de logro de los vacíos se
deben definirse en la definieron en la especificación del
especificación del ciclo y los ciclo y los parámetros se cumplieron
parámetros deben cumplirse durante los ciclos PPQ.
durante los ciclos PPQ.
• El número de repeticiones y la
• El número de repeticiones y la variación en cualquier repetición se
variación en cualquier repetición definieron en la especificación del
deben definirse en la ciclo y los parámetros se cumplieron
especificación del ciclo y los durante los ciclos PPQ.
parámetros deben Acondicionamiento
cumplirse (al 37.82 - 41.37°C
Temperatura 20 -45°C
durante los ciclosfinal
PPQ.de la morada de
vapor)
Acondicionamiento (al 85,2 - 92,1%
Rh >30%
final de la morada de
vapor)
• Los niveles de presión y la tasa de • Los niveles de presión y la tasa de
logro de vacíos o niveles de HR logro de vacíos se definieron en la
Fase de deben definirse en la especificación especificación del ciclo y los
del ciclo y los parámetros deben parámetros se cumplieron durante los
acondiciona
miento/fin
de la morada • El número de pulsos de vapor • El número de pulsos de vapor se
de vapor debe definirse en la especificación definió en la especificación del ciclo
del ciclo y los parámetros deben y los parámetros se cumplieron
• El tiempo total para la fase de • El tiempo total para la fase de
acondicionamiento debe definirse acondicionamiento se definió en la
en la especificación del ciclo y los especificación del ciclo y los
parámetros deben cumplirse parámetros se cumplieron durante
durante los ciclos PPQ los ciclos PPQ.
Formato: F094101D (R021, C00002708)

Esterilización
• La temperatura de la cámara • La temperatura de la cámara durante

durante el acondicionamiento el acondicionamiento se definió en
debe definirse en la la especificación del ciclo y los
especificación del ciclo y los parámetros se cumplieron durante los
parámetros deben cumplirse ciclos PPQ
durante los ciclos PPQ.
• La temperatura y la humedad de la
• La temperatura y la humedad de carga al final del acondicionamiento
la carga al final del se definieron en la especificación
acondicionamiento deben del ciclo y los parámetros se
definirse en la especificación del cumplieron durante los ciclos PPQ.
ciclo y los parámetros deben 39.94 -
Temperatura
cumplirse duranteFase los de exposición
ciclos PPQ. 20-45°C
42°C
• La presión de inyección de EO,

• La presión de inyección EO, el tiempo
el tiempo se definieron en la
debe definirse en la especificación del
ciclo y los parámetros deben cumplirse
parámetros se cumplieron
durante los ciclos PPQ
Fase de exposición durante los ciclos PPQ
Pesaje de gas - 60kg

Verificación
Evidencia de que del peso del
el gas EO fue Fase de exposición gas, Presión – 550mbar
admitido en la aumento de
cámara Especifica
la presión ciones (
531-
• La profundidad y la velocidad de • La profundidad y la 565mbars)
velocidad de los
los vacíos deben definirse en la vacíos se definieron en la
especificación del ciclo y los especificación del ciclo y los
parámetros deben cumplirse parámetros se cumplieron durante
durante los ciclos PPQ. los ciclos PPQ.
Enrojecimient • La profundidad y la velocidad de las • La profundidad y la velocidad de las

o posterior a presiones asociadas con los presiones asociadas con los lavados
la exposición lavados de aire y nitrógeno deben de aire y nitrógeno se definieron en
ciclo y los parámetros deben parámetros se cumplieron durante
cumplirse durante los ciclos PPQ. los ciclos PPQ.
• El número de repeticiones de • El número de repeticiones de lavados
lavados debe definirse en la se definió en la especificación del
especificación
El tiempo del ciclodentro
y la temperatura y los de ciclo yylos
El tiempo la parámetros
temperaturase cumplieron
dentro de la
parámetros deben cumplirse
la sala de aireación deben definirse durante los ciclos PPQ.
sala de aireación se definieron en la
Desgasificaci en ladurante los ciclos
especificación delPPQ.
ciclo y los especificación del ciclo y los parámetros
ón (si parámetros deben cumplirse deben ser durante los ciclos PPQ.
corresponde) durante los ciclos PPQ.
Temperatura Estado 15- 45°C 37,82 a 38,75 °C
estacionario
Formato: F094101D (R021, C00002708)

Esterilización
Sección 6.2 No conformidades y resultados de la investigación .
1. Durante el MPQ/PPQ para las cargas de densidad máxima, batch # 11993801 PCD externo #29
no se probó ya que no se recuperó de la carga dentro del tiempo especificado. De acuerdo con
la sección 8.1 de I- ISI-994, D00171765-Rev001-Support5, el número de indicadores biológicos
requeridos para la prueba se basa en el volumen de carga de la cámara que se utiliza según el
orientación en el anexo C de la norma ISO11135:2014; además se añaden dos (2) indicadores
biológicos adicionales como margen de seguridad. Por lo tanto, esto no tiene ningún impacto
en el resultado de la validación, ya que se utilizó la cantidad mínima de indicadores biológicos y
no se requirió ninguna acción.
2. En los criterios de aceptación del perfil de producto D00173606-Rev001Support4-, la humedad

de carga superó el valor tentativo establecido. Para el perfil del producto, los atributos que no se
controlan directamente se designan con un valor provisional y esperado que se revisará,
confirmará o revisará (según sea necesario) junto con el proceso. datos de rendimiento y
resultados microbiológicos. La especificación máxima para la humedad de la carga fue del 80%
y el valor real alcanzado fue del 81,8%. El valor real registrado no tendrá ningún impacto en la
validación, ya que el propósito de la humedad durante la fase de preacondicionamiento es
garantizar que los BI se reactiven y acondicionar el producto para permitir la penetración del
gas EO. Además, durante la fase de esterilización, el requisito es que la HR sea superior al 30%
sin especificación máxima. Esto no tiene ningún impacto en el resultado de la validación y, por
lo tanto, no se requiere ninguna acción.
Sección 6.3 Errores y cómo se abordan

En el protocolo D00171765-Rev001-Support1, los criterios de aceptación del perfil del producto, se
observaron los siguientes errores de documentación:
1. Tiempo de transferencia desde el preacondicionamiento hasta la esterilización: La

especificación en el soporte # 1 estableció un máximo de 60 minutos; esto debe ser un
mínimo de 60 minutos, ya que la especificación de rutina es de un máximo de 60 minutos.
Durante el medio ciclo, el tiempo de transferencia debe ser de 60 minutos como mínimo
para demostrar el peor de los casos durante el procesamiento de rutina.
Nota: El OQ se ejecutó en un ciclo completo de rutina y, por lo tanto, el tiempo de
transferencia debe haber sido inferior a 60 minutos.
2. Tiempo de exposición al gas: la especificación establecía que el tiempo era de 7 a 7 horas y 30
minutos; esto debería ser de 3 horas y 30 minutos como máximo.
Según la sección 12 del protocolo D00171765, el perfil del producto se llevó a cabo como parte de
los semiciclos. Las especificaciones en el documento de soporte # 1 del protocolo D00171765 no se
ajustaron para los requisitos de medio ciclo según el medio ciclo PRS25806. El ciclo se llevó a cabo
de acuerdo con los requisitos del protocolo y el PRS y los errores mencionados anteriormente no
tienen ningún impacto en el resultado de la validación, ya que fueron solo errores de documentación.
Sección 7: Pruebas residuales

Las pruebas residuales no se realizaron como parte de esta validación. Se han realizado pruebas
residuales para todos los productos, los detalles se pueden encontrar en la sección correspondiente de
los archivos técnicos asociados con cada familia de productos.
Formato: F094101D (R021, C00002708)

Esterilización
Sección 8: Pruebas de calidad del producto

Las pruebas de calidad del producto no se llevaron a cabo como parte de esta validación. Las
pruebas de calidad del producto se han llevado a cabo para todos los productos y los detalles de
todas las pruebas realizadas se pueden encontrar en las secciones pertinentes del archivo técnico
asociado a cada uno. familia de productos.
Sección 9: Requisitos de capacitación

9.1 La validación fue ejecutada por la instalación contratada Synergy Health Ireland Limited.
Synergy Health llevó a cabo la validación según el protocolo en el documento de soporte
5 del protocolo D00171765 y fue responsable de cualquier requisito de capacitación.
9.2 CirL no requirió requisitos de capacitación como parte de esta validación.
Sección 10: Conclusión

Sobre la base de los resultados del OQ y MPQ/PPQ, el ciclo de rutina de Cook Ireland en las líneas 8 y 9 de
Synergy Health Ireland ha sido recalificado con éxito.
Formato: F094101D (R021, C00002708)

PROYECTO DE ROTULADO
MEDIATO
FABRICADO POR: COOK IRELAND LIMITED (Irlanda)
IMPORTADO POR: CORPORACION FARMACEUTICA INTEGRAL S.A.C.
Calle los Petroleros N° 170, Urb. Los Ingenieros, La Molina RUC:
206042703000
R.S. N°:…………….
Nota: EL PRESENTE ROTULADO APLICA TAMBIEN PARA LOS

CODIGOS: EVO-25- 30-6-C, EVO-25-30-10-C VARIANDO POR LOS
NUMEROS DE REFERENCIA Y MEDIDAS
PROYECTO DE ROTULADO INMEDIATO
Nota: EL PRESENTE ROTULADO APLICA TAMBIEN PARA LOS
CODIGOS: EVO-25- 30-6-C, EVO-25-30-10-C VARIANDO POR LOS
NUMEROS DE REFERENCIA Y MEDIDAS
Title:Evolution Colonic-Duodenal Stent System Design Failure Modes and Effects Analysis
Document #: D00055138 QMS Owner: Cook Ireland Ltd.
Rev #: 014 Legacy Number: dFMEA0009
FMEA Cover Page

Product Name(s): Evolution Colonic-Duodenal Stent System
Prefixes Affected: EVO-xx-yy-zz-D, EVO-xx-yy-zz-C
Participants
Name Team Function
Jamie Devlin Sustaining Engineer Consultant
Cathal Geraghty Sustaining Engineer Consultant
Kevin Quinn Sustaining Engineer Consultant
Comments: All risk categories should be verified prior to approval.
COPYRIGHT Cook Ireland Ltd. 2008 Form: F0406A (R025, C00005168) Page 1 of 368
Referenced Documents
Internal Documents External Documents
Prefix
N/A D00055138-Rev014-Support 1 Evolution Colonic-Duodenal Stent System Complaints 03Jul2014_03 Jul N/A
2017
N/A D00055138-Rev014-Support 2 Evolution Colonic-Duodenal Stent System Sales 03Jul2014_03 Jul 2017 N/A
Rating System
Severity Initial Probability of Occurrence Probability of Occurrence as a Result of Risk Control
Rating Description Criteria Rating Rating Qualitative
1 None No health consequence / nuisance to patient or end user Remote 0 Will always be detected
2 Negligible Temporary discomfort - medical intervention not required Unlikely 1 Almost certain to detect, near 100%
3 Minor Harm requiring medical intervention within the same operating procedure, no further hospital stay required Likely 2 Very high probability of detection
4 Significant Harm requiring secondary intervention, prolonged hospitalisation required 3 High probability of detection
5 Severe Permanent irreversible impairment / life-threatening illness or injury 4 Poor probability of detection
6 Critical Death 5 Very poor probability of detection
Failure Modes and Effects Analysis

Min
Has risk
Probability Is a
Functional Probability of Risk Category reduced
Initial Initial of specific
Design Element / Performance Description of Potential Effects of Potential Causes of Occurrence as a Effectiveness of Risk after as much RBA
Potential Failure Modes Severity Probability of Risk Risk Control Activities Occurrence RBA
Process Step Requirements / Failure Failure Result of Risk Control Measure Implementation as Reference
Occurrence Category as a Result required
Sub-Processes Control (ind) of Risk Control possible
of Risk ?
?
Control
1. Device 1.1. Device 1.1.1. Device materials are not Situation Device / Risk Control End-user/patient cannot
materials materials physiologically compatible Components which are not component Materials have been specified by Engineering not experience situation
must be (patient contacting) physiologically compatible are in contains latex to contain Latex in the patient contacting Occurrence = 0%
physiologi patient contact components of the device design. Based on information
0 0 III Yes No N/A
cally Potential Cause of failure eliminated from vendor latex is not
compatibl Harm present in any
e Allergic reaction / toxic or Implementation component of the
immune response DWG0497 'TTS SEMS Assembly' device.
Impact Device / Risk Control End-user/patient cannot

Permanent irreversible component Materials have been specified by Engineering not experience situation
impairment, life-threatening contains phthalates to contain Phthalates in the patient contacting Occurrence = 0%
illness or injury components of the device design. Based on information
0 0 III Yes No N/A
Potential Cause of failure eliminated from vendor phthalates
are not present in any
Implementation component of the
DWG0497 'TTS SEMS Assembly' device.
(Adhesives only) Risk Control The effectiveness is
Introducer Adhesive materials have been specified by inherent in the risk
component Engineering to have CMR level specified below control
contains the observable effect level for components
carcinogenic / (Adhesive Loctite 4061) (Regulation (EC)
1 1 IIA Yes No N/A
mutagenic and No:1272/2008)
reprotoxic Potential Cause of failure addressed
substances
(CMRs) Implementation
DWG0497 'TTS SEMS Assembly'
Introducer Risk Control None
component Braided polyimide, safety wire,retrieval loop,
contains tantalum marker band and outer sheath contain
carcinogenic / nickel (Note: Nickel contained in the outer sheath
mutagenic and and polyimide is encapsulated therefore the nickel
5 5 I Yes Yes D00170896
reprotoxic here is non patient contacing). Nickel is CMR
substances There is no Risk Control
5 Remote I (CMRs)
Implementation
None.
Stent component Risk Control None
contains Stent material is nitinol as specified by
carcinogenic / Engineering. This material contains Titanium and
mutagenic and also Nickel which is a CMR substance in its
reprotoxic composition. Nitinol offers superelastic & shape
substances memory material properties for this application.
(CMRs) Stent marker bands are Tantalum which is also a
CMR substance, and as specified by design have
CMR level specified below the observable effect 5 5 I Yes Yes D00170896
level for components
There is no Risk Control
Implementation
RMS0023 'Tantalum Radiopaque Band'
DWG0288 'Enteral Stent '
DWG0289 'Colonic Stent'
Device / Risk Control None
component Stent and Safety Wire material is nitinol as
contains nickel specified by Engineering. Braided polyimide and
outer sheath contain Stainless Steel. These
materials contains Nickel. Nickel is CMR. 5 5 I Yes Yes D00170896
There is no Risk Control
Implementation
Other materials Risk Control Biocompatibility testing
used in device are Known biocompatible materials have been has been completed for
not biocompatible specified by design of the device. 1 EVO-xx-yy-zz-D and 1 IIA Yes No N/A
Potential Cause of failure addressed EVO-xx-yy-zz-C devices
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: BA12.028-A
Implementation
1.1.2. Device materials are not Situation Device / Risk Control End-user/patient cannot
physiologically compatible (non- Non-patient-contacting component Materials have been specified by Engineering not experience situation
patient contacting) components are not contains latex to contain Latex in the non-patient contacting Occurrence = 0%
physiologically compatible components of the device design. Based on information
Potential Cause of failure eliminated from vendor latex is not
Harm present in any
0 0 III Yes No N/A
No harm to end user Implementation component of the
Impact DWG0481 'Tray - Gastro SEMS TTS Lid'
No health consequence/ DWG0009 'Packaging Pouches'
Nuisance to patient or end user DWG0348 'Tray - Gastro SEMS TTS '
RMS0044 'Rigid Protective Tubing'
Device / Risk Control End-user/patient cannot
component Materials have been specified by design not to experience situation
contains phthalates contain Phthalates in the non-patient contacting Occurrence = 0%
components of the device design. Based on information
Potential Cause of failure eliminated from vendor latex is not
present in any
0 0 III Yes No N/A
Implementation component of the
DWG0481 'Tray - Gastro SEMS TTS Lid'
DWG0009 'Packaging Pouches'
DWG0348 'Tray - Gastro SEMS TTS '
Device / Risk Control The effectiveness is
component Stainless Steel (TTS cannula, Pulley shaft, drive inherent in the risk
contains shaft, Idler pin, SEMS compression spring, and control
carcinogenic / cannula K22R) is used in non-patient contacting
mutagenic and components of device design. Stainless Steel and
reprotoxic contains Nickel. Nickel is CMR.
substances
1 Likely III (CMRs) Materials have been specified by design. There
are no risks of CMRs in non-patient contacting
components used in the device as they do not
come in contact with the patient. 1 1 III Yes No N/A
Potential Cause of failure addressed
Implementation
DWG0332 'TTS Cannula '
DWG0326 'Pulley Shaft'
DWG0327 'DriveShaft'
DWG0328 'Idler Pin'
DWG0346 'SEMS Compression Spring'
RMS0025 'Hypodermic Tubing'
Device / Risk Control The effectiveness is
component Nickel used in (TTS cannula, Pulley shaft, drive inherent in the risk
contains nickel shaft, Idler pin, SEMS compression spring, and control
cannula K22R) material.
The Nickel element of these components are
housed within the handle, or the inside of the
sheath, and thereby are non patient contacting.
1 1 III Yes No N/A

Potential Cause of failure addressed
Implementation
DWG0332 'TTS Cannula '
DWG0326 'Pulley Shaft'
DWG0327 'DriveShaft'
DWG0328 'Idler Pin'
RMS0025 'Hypodermic Tubing'
1.2. Device 1.2.1. Plastic components are cracked Situation During Risk Control History shows 0 failure
materials before use. Mechanical integrity of the device transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
must is compromised before 1 Likely III ge, the base Engineering to maintain dimensional stability 1 used in patients over a 3 1 III Yes No N/A
maintain procedure, device replaced. polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
mechanic due to exposure to transportation. Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
al integrity Harm low temperatures.
to point of no harm to patient Design solutions employed using state of the art Transportation Testing
use. approaches which address the cause of has been completed for
Impact failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
No health consequence/ features/ geometry/ materials which provide a per ref: VAL07-0011
Nuisance to patient or end user high degree of assurance of robust designs REPORT3 Rev 0
established effective through clinical use. EVO-xx-yy-zz-C & EVO-
xx-yy-zz-D products are
Implementation of similar design to EVO-
DWG0497 'TTS SEMS Assembly' xx-yy-zz-E product(s)
DWG0009 'Packaging Pouches' tested
DWG0348 'Tray - Gastro SEMS TTS ' Transportation Testing
DWG0481 'Tray - Gastro SEMS TTS Lid' has been completed for
CHT0037 'Specification for Packaging Boxes' EVO-xx-yy-zz-D and
EVO-xx-yy-zz-C devices
per ref: VAL07-0012
REPORT3 Rev 0
EVO-xx-yy-zz-C & EVO-
of similar design to EVO-
xx-yy-zz-E product(s)
tested
During Risk Control History shows 0 failure
transportation, the Materials are engineered plastics specified by (s) out of 14724 devices
base polymers Engineering to maintain dimensional stability used in patients over a 3
degrades due to when exposed to high temperatures during year (03 Jul 2014 to 03
exposure to high transportation. Jul 2017) period.
temperatures.
Design solutions employed using state of the art Transportation Testing
approaches which address the cause of has been completed for
failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
features/ geometry/ materials which provide a per ref: VAL07-0011
high degree of assurance of robust designs REPORT3 Rev 0
Implementation 1 of similar design to EVO- 1 III Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
plastic contracts Engineering to maintain dimensional stability used in patients over a 3
due to low when exposed to low temperatures during year (03 Jul 2014 to 03
temperatures. It is transportation. Jul 2017) period.
subject to
mechanical stress Design solutions employed using state of the art Transportation Testing
because it approaches which address the cause of has been completed for
becomes failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
constrained by features/ geometry/ materials which provide a per ref: VAL07-0011
components it high degree of assurance of robust designs REPORT3 Rev 0
surrounds. established effective through clinical use. EVO-xx-yy-zz-C & EVO-
1 xx-yy-zz-D products are 1 III Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
During sterilisation, Risk Control History shows 0 failure
the plastic expands Materials are engineered plastics specified by (s) out of 14724 devices
due to heat and Engineering to maintain dimensional stability used in patients over a 3
humidity of that when exposed to high temperatures and humidity year (03 Jul 2014 to 03
process. It is during sterilisation. Jul 2017) period.
subject to
mechanical stress Design solutions employed using state of the art
because it approaches which address the cause of Simulated Use Testing
becomes failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
constrained by features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
surrounding high degree of assurance of robust designs EVO-xx-yy-zz-C devices
components. established effective through clinical use. per ref: VAL07-0016
REPORT Rev 1
Implementation EVO-xx-yy-zz-C & EVO-
DWG0497 'TTS SEMS Assembly' xx-yy-zz-D products are
DWG0009 'Packaging Pouches' of similar design to EVO-
DWG0348 'Tray - Gastro SEMS TTS ' xx-yy-zz-E product(s)
DWG0481 'Tray - Gastro SEMS TTS Lid' tested
Over time the base Risk Control History shows 0 failure
plastic polymer Materials are engineered plastics specified by (s) out of 14724 devices
degrades due to Engineering to maintain dimensional stability used in patients over a 3
exposure to light. when exposed to light. year (03 Jul 2014 to 03
Jul 2017) period.
Design solutions employed using state of the art
approaches which address the cause of 25 Months Realtime
failure/failure mode. Such solutions relate to Aging has been
features/ geometry/ materials which provide a completed for EVO-xx-
high degree of assurance of robust designs yy-zz-D and EVO-xx-yy-
established effective through clinical use. zz-C devices per ref:
VAL08-0048 REPORT 2
Implementation 1 Rev 0 1 III Yes No N/A
DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-D
DWG0009 'Packaging Pouches' products are of similar
DWG0348 'Tray - Gastro SEMS TTS ' design to EVO-xx-yy-zz-
DWG0481 'Tray - Gastro SEMS TTS Lid' C product(s) tested
CHT0037 'Specification for Packaging Boxes' Aging Rationale (25
month shelf life) for
Outer Sheath (18-359,
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Situation During Risk Control History shows 0 failure
Mechanical integrity of the device transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
is compromised during procedure ge, the base Engineering to maintain dimensional stability used in patients over a 3
prior to stent deployment. polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
Replacement device required due to exposure to transportation. Jul 2017) period.
low temperatures.
Harm Design solutions employed using state of the art Transportation Testing
Additional exposure to sedation, approaches which address the cause of has been completed for
radiation and/or contrast failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Impact high degree of assurance of robust designs REPORT3 Rev 0
Temporary discomfort- medical established effective through clinical use. EVO-xx-yy-zz-C & EVO-
intervention not required xx-yy-zz-D products are
2 Likely IIA Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
temperatures.
Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
becomes failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
REPORT Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
Jul 2017) period.
VAL08-0048 REPORT 2
Implementation 1 Rev 0 1 IIA Yes No N/A
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Mechanical integrity of the device transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
is compromised during procedure ge, the base Engineering to maintain dimensional stability used in patients over a 3
application. Partially deployed polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
stent can not be deployed fully or due to exposure to transportation. Jul 2017) period.
recaptured. Replacement device low temperatures.
required Design solutions employed using state of the art Transportation Testing
Harm failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Additional exposure to sedation, features/ geometry/ materials which provide a per ref: VAL07-0011
radiation and/or contrast high degree of assurance of robust designs REPORT3 Rev 0
Impact xx-yy-zz-D products are
Temporary discomfort- medical Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
intervention not required DWG0497 'TTS SEMS Assembly' xx-yy-zz-E product(s)
per ref: VAL07-0012
REPORT3 Rev 0
2 Likely IIA xx-yy-zz-D products are
tested
temperatures.
features/ geometry/ materials which provide a 1 per ref: VAL07-0011 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
Jul 2017) period.
high degree of assurance of robust designs 1 yy-zz-D and EVO-xx-yy- 1 IIA Yes No N/A
VAL08-0048 REPORT 2
Implementation Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Incorrect placement location of transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
stent over healthy tissue. ge, the base Engineering to maintain dimensional stability used in patients over a 3
Additional stent is required. polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
due to exposure to transportation. Jul 2017) period.
Harm low temperatures.
Continuation of occlusion (which Design solutions employed using state of the art Transportation Testing
can be treated within the same approaches which address the cause of has been completed for
procedure) failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Harm requiring medical established effective through clinical use. EVO-xx-yy-zz-C & EVO-
intervention, within the same xx-yy-zz-D products are
operating procedure. No further Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
hospital stay required DWG0497 'TTS SEMS Assembly' xx-yy-zz-E product(s)
per ref: VAL07-0012
REPORT3 Rev 0
tested
temperatures.
3 Likely IIB Design solutions employed using state of the art Transportation Testing
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
mechanical stress Design solutions employed using state of the art 1 Transportation Testing 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Device components break during transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
procedure and expose sharp ge, the base Engineering to maintain dimensional stability used in patients over a 3
plastic edges to device user. polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
Minor cut injury to user Design solutions employed using state of the art Transportation Testing
2 Likely IIA approaches which address the cause of 1 has been completed for 1 IIA Yes No N/A
Temporary discomfort- medical features/ geometry/ materials which provide a per ref: VAL07-0011
intervention not required high degree of assurance of robust designs REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
temperatures.
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
due to heat and Engineering to maintain dimensional stability 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
subject to
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
plastic edges to patient polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
Minor trauma to mucosa Design solutions employed using state of the art Transportation Testing
Temporary discomfort- medical features/ geometry/ materials which provide a per ref: VAL07-0011
intervention not required high degree of assurance of robust designs REPORT3 Rev 0
2 Likely IIA DWG0481 'Tray - Gastro SEMS TTS Lid' has been completed for
per ref: VAL07-0012
REPORT3 Rev 0
tested
degrades due to when exposed to high temperatures during 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
temperatures.
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
exposure to light. when exposed to light. 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Perforation and/or minor bleed Design solutions employed using state of the art Transportation Testing
(self-limited) approaches which address the cause of has been completed for
Impact features/ geometry/ materials which provide a per ref: VAL07-0011
Harm requiring medical high degree of assurance of robust designs REPORT3 Rev 0
intervention, within the same established effective through clinical use. EVO-xx-yy-zz-C & EVO-
operating procedure. No further xx-yy-zz-D products are
hospital stay required Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
3 Likely IIB During Risk Control History shows 0 failure
temperatures.
DWG0497 'TTS SEMS Assembly' 1 xx-yy-zz-E product(s) 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Device components break during 4 Unlikely IIB transportation/stora Materials are engineered plastics specified by 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Perforation (medical intervention Design solutions employed using state of the art Transportation Testing
required) and/or major bleed approaches which address the cause of has been completed for
(transfusion required) failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Harm requiring secondary established effective through clinical use. EVO-xx-yy-zz-C & EVO-
intervention and/ or prolonged xx-yy-zz-D products are
hospitalisation required Implementation of similar design to EVO-
per ref: VAL07-0012
REPORT3 Rev 0
tested
temperatures.
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
components it high degree of assurance of robust designs 1 REPORT3 Rev 0 1 IIA Yes No N/A
per ref: VAL07-0012
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Outer sheath splits exposing transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
inner braid/coil to stricture wall ge, the base Engineering to maintain dimensional stability used in patients over a 3
polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
Harm due to exposure to transportation. Jul 2017) period.
Minor trauma to mucosa low temperatures.
Impact approaches which address the cause of has been completed for
Temporary discomfort- medical failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
intervention not required features/ geometry/ materials which provide a per ref: VAL07-0011
2 Likely IIA established effective through clinical use. 1 EVO-xx-yy-zz-C & EVO- 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
temperatures.
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
because it approaches which address the cause of 1 Simulated Use Testing 1 IIA Yes No N/A
REPORT Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Delivery system plastic transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
component breaks during ge, the base Engineering to maintain dimensional stability used in patients over a 3
deployment/recapture and left in polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
the patient. The component due to exposure to transportation. Jul 2017) period.
expels naturally. low temperatures.
Harm approaches which address the cause of has been completed for
No retrieval required. failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
No health consequence/ established effective through clinical use. EVO-xx-yy-zz-C & EVO-
Nuisance to patient or end user xx-yy-zz-D products are
per ref: VAL07-0012
REPORT3 Rev 0
1 Likely III EVO-xx-yy-zz-C & EVO-
tested
temperatures.
failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-D devices 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 III Yes No N/A
REPORT Rev 1
Jul 2017) period.
features/ geometry/ materials which provide a 1 completed for EVO-xx- 1 III Yes No N/A
VAL08-0048 REPORT 2
Min
Has risk
Probability Is a
of Risk ?
?
Control
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Delivery system plastic transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
component breaks during ge, the base Engineering to maintain dimensional stability used in patients over a 3
deployment/recapture and left in polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
the patient. Device retrieval using due to exposure to transportation. Jul 2017) period.
forceps etc. low temperatures.
Harm approaches which address the cause of has been completed for
Foreign body / matter left in failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
patient which can be retrieved features/ geometry/ materials which provide a per ref: VAL07-0011
within the same procedure. high degree of assurance of robust designs REPORT3 Rev 0
Impact xx-yy-zz-D products are
Harm requiring medical Implementation 1 of similar design to EVO- 1 IIA Yes No N/A
intervention, within the same DWG0497 'TTS SEMS Assembly' xx-yy-zz-E product(s)
operating procedure. No further DWG0009 'Packaging Pouches' tested
hospital stay required DWG0348 'Tray - Gastro SEMS TTS ' Transportation Testing
per ref: VAL07-0012
REPORT3 Rev 0
tested
3 Likely IIB exposure to high transportation. Jul 2017) period.
temperatures.
per ref: VAL07-0012
REPORT3 Rev 0
tested
temperatures. It is transportation. 1 Jul 2017) period. 1 IIA Yes No N/A
subject to
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
1 1 IIA Yes No N/A
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
Outer sheath detaches during transportation/stora Materials are engineered plastics specified by (s) out of 14724 devices
stent deployment. Partially ge, the base Engineering to maintain dimensional stability used in patients over a 3
deployed stent can not be polymers degrades when exposed to low temperatures during year (03 Jul 2014 to 03
deployed fully or recaptured. due to exposure to transportation. Jul 2017) period.
Delivery system with partially 2 Likely IIA low temperatures. 1 1 IIA Yes No N/A
deployed stent must be removed Design solutions employed using state of the art Transportation Testing
from patient. Replacement device approaches which address the cause of has been completed for
required. failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Harm high degree of assurance of robust designs REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
Additional exposure to sedation, established effective through clinical use. EVO-xx-yy-zz-C & EVO-
radiation and/or contrast xx-yy-zz-D products are
Impact DWG0497 'TTS SEMS Assembly' xx-yy-zz-E product(s)
Temporary discomfort- medical DWG0009 'Packaging Pouches' tested
intervention not required DWG0348 'Tray - Gastro SEMS TTS ' Transportation Testing
per ref: VAL07-0012
REPORT3 Rev 0
tested
temperatures.
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to
per ref: VAL07-0012
REPORT3 Rev 0
tested
the plastic expands Materials are engineered plastics specified by 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
subject to
REPORT Rev 1
Jul 2017) period.
VAL08-0048 REPORT 2
18-360 & 18-361) has
been completed for
EVO-xx-yy-zz-D and
per ref: TST16-040
1.2.2. Plastic components are distorted Situation During sterilisation Risk Control History shows 0 failure
before use. Procedure cannot be started. the plastic releases Materials are engineered plastics specified by (s) out of 14724 devices
Replacement device required. residual stress due Engineering to maintain dimensional stability used in patients over a 3
to the heat. when exposed to high temperatures during year (03 Jul 2014 to 03
Harm sterilisation. Jul 2017) period.
No harm to patient
Impact approaches which address the cause of Simulated Use Testing
No health consequence/ failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
Nuisance to patient or end user features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
high degree of assurance of robust designs EVO-xx-yy-zz-C devices
established effective through clinical use. per ref: VAL07-0016
REPORT Rev 1
1 Likely III DWG0348 'Tray - Gastro SEMS TTS ' xx-yy-zz-E product(s)
During sterilisation Risk Control History shows 0 failure
humidity. It is when exposed to high temperatures and humidity year (03 Jul 2014 to 03
subject to during sterilisation. Jul 2017) period.
because it approaches which address the cause of 1 Simulated Use Testing 1 III Yes No N/A
REPORT Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
DWG0348 'Tray - Gastro SEMS TTS ' of similar design to EVO-
DWG0481 'Tray - Gastro SEMS TTS Lid' xx-yy-zz-E product(s)
During the Risk Control History shows 0 failure
procedure the Materials are engineered plastics specified by (s) out of 14724 devices
plastic expands Engineering to maintain dimensional stability used in patients over a 3
due to the warm during the procedure when exposed to the year (03 Jul 2014 to 03
temperature of the temperature of the body. Jul 2017) period.
body. It is subject Design solutions employed using state of the art
to mechanical approaches which address the cause of Simulated Use Testing
stress because it failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
becomes features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
constrained by high degree of assurance of robust designs EVO-xx-yy-zz-C devices
surrounding established effective through clinical use. per ref: NCT16-0036-R
components. Ver 0
Implementation EVO-xx-yy-zz-D
DWG0497 'TTS SEMS Assembly' products are of similar
design to EVO-xx-yy-zz-
C product(s) tested
Over time the Risk Control History shows 0 failure
plastic creeps due Materials are engineered plastics specified by (s) out of 14724 devices
to the presence of Engineering to maintain dimensional stability and used in patients over a 3
a constant minimise creep due to constant mechanical load. year (03 Jul 2014 to 03
mechanical load. Jul 2017) period.
approaches which address the cause of
failure/failure mode. Such solutions relate to Simulated Use Testing
features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
high degree of assurance of robust designs EVO-xx-yy-zz-D and
established effective through clinical use. EVO-xx-yy-zz-C devices
per ref: NCT16-0036-R
Implementation Ver 0
products are of similar
C product(s) tested
Situation During sterilisation Risk Control History shows 0 failure
Plastic component detaches from the plastic releases Materials are engineered plastics specified by (s) out of 14724 devices
the delivery system during residual stress due Engineering to maintain dimensional stability used in patients over a 3
deployment/recapture and is left to the heat. when exposed to high temperatures during year (03 Jul 2014 to 03
in the patient. The component sterilisation. Jul 2017) period.
expels naturally.
Harm approaches which address the cause of Simulated Use Testing
No retrieval required. failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
Impact high degree of assurance of robust designs EVO-xx-yy-zz-C devices
No health consequence/ established effective through clinical use. per ref: VAL07-0016
Nuisance to patient or end user REPORT Rev 1
1 Likely III DWG0481 'Tray - Gastro SEMS TTS Lid' tested
constrained by features/ geometry/ materials which provide a 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
REPORT Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
body. It is subject Design solutions employed using state of the art
to mechanical approaches which address the cause of Simulated Use Testing
stress because it failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
becomes features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
constrained by high degree of assurance of robust designs EVO-xx-yy-zz-C devices
surrounding established effective through clinical use. per ref: NCT16-0036-R
components. Ver 0
C product(s) tested
C product(s) tested
Plastic component detaches from the plastic releases Materials are engineered plastics specified by (s) out of 14724 devices
the delivery system during residual stress due Engineering to maintain dimensional stability used in patients over a 3
deployment/recapture and is left to the heat. when exposed to high temperatures during year (03 Jul 2014 to 03
in the patient. Device requires sterilisation. Jul 2017) period.
endoscopic removal.
Harm approaches which address the cause of Simulated Use Testing
Foreign body / matter left in failure/failure mode. Such solutions relate to has been completed for
1 1 IIA Yes No N/A
patient which can be retrieved features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
within the same procedure. high degree of assurance of robust designs EVO-xx-yy-zz-C devices
Impact REPORT Rev 1
Harm requiring medical Implementation EVO-xx-yy-zz-C & EVO-
intervention, within the same DWG0497 'TTS SEMS Assembly' xx-yy-zz-D products are
operating procedure. No further DWG0009 'Packaging Pouches' of similar design to EVO-
hospital stay required DWG0348 'Tray - Gastro SEMS TTS ' xx-yy-zz-E product(s)
3 Likely IIB During sterilisation Risk Control History shows 0 failure
constrained by features/ geometry/ materials which provide a 1 EVO-xx-yy-zz-D and 1 IIA Yes No N/A
REPORT Rev 1
procedure the Materials are engineered plastics specified by 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
body. It is subject
to mechanical Design solutions employed using state of the art Simulated Use Testing
stress because it approaches which address the cause of has been completed for
becomes failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
constrained by features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
surrounding high degree of assurance of robust designs per ref: NCT16-0036-R
components. established effective through clinical use. Ver 0
EVO-xx-yy-zz-D
Implementation products are of similar
DWG0497 'TTS SEMS Assembly' design to EVO-xx-yy-zz-
C product(s) tested
features/ geometry/ materials which provide a 1 has been completed for 1 IIA Yes No N/A
C product(s) tested
Handle gears do not mesh/ the plastic releases Materials are engineered plastics specified by (s) out of 14724 devices
transfer correctly. Difficulty in residual stress due Engineering to maintain dimensional stability used in patients over a 3
deployment/recapture of stent. to the heat. when exposed to high temperatures during year (03 Jul 2014 to 03
Prolonged procedure. sterilisation. Jul 2017) period.
Harm Design solutions employed using state of the art

Additional exposure to sedation, approaches which address the cause of Simulated Use Testing
radiation and/or contrast failure/failure mode. Such solutions relate to has been completed for
1 1 IIA Yes No N/A
Temporary discomfort- medical established effective through clinical use. per ref: VAL07-0016
intervention not required REPORT Rev 1
2 Likely IIA due to heat and Engineering to maintain dimensional stability used in patients over a 3
mechanical stress
because it Design solutions employed using state of the art Simulated Use Testing
becomes approaches which address the cause of has been completed for
constrained by failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
1 1 IIA Yes No N/A
surrounding features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
components. high degree of assurance of robust designs per ref: VAL07-0016
established effective through clinical use. REPORT Rev 1
Implementation xx-yy-zz-D products are
DWG0497 'TTS SEMS Assembly' of similar design to EVO-
plastic expands Engineering to maintain dimensional stability 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
body. It is subject
EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
Handle gears do not mesh/ the plastic releases Materials are engineered plastics specified by (s) out of 14724 devices
transfer correctly. Stent cannot residual stress due Engineering to maintain dimensional stability used in patients over a 3
be deployed. Replacement to the heat. when exposed to high temperatures during year (03 Jul 2014 to 03
device required. sterilisation. Jul 2017) period.

Insignificant delay in procedure. approaches which address the cause of Simulated Use Testing
failure/failure mode. Such solutions relate to has been completed for
1 1 III Yes No N/A
Impact features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
No health consequence/ high degree of assurance of robust designs EVO-xx-yy-zz-C devices
Nuisance to patient or end user established effective through clinical use. per ref: VAL07-0016
REPORT Rev 1
1 Likely III humidity. It is when exposed to high temperatures and humidity year (03 Jul 2014 to 03
mechanical stress
because it Design solutions employed using state of the art Simulated Use Testing
becomes approaches which address the cause of has been completed for
constrained by failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
1 1 III Yes No N/A
surrounding features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
components. high degree of assurance of robust designs per ref: VAL07-0016
DWG0497 'TTS SEMS Assembly' of similar design to EVO-
due to the warm during the procedure when exposed to the 1 year (03 Jul 2014 to 03 1 III Yes No N/A
body. It is subject
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
1.2.3. Adhesive joints are cracked Situation During Risk Control History shows 0 failure
before use. Procedure cannot be started. transportation, the The material of the adhesive is designed to (s) out of 14724 devices
Replacement device required. base polymers withstand low temperatures. used in patients over a 3
degrades due to year (03 Jul 2014 to 03
Harm exposure to low Design solutions employed using state of the art Jul 2017) period.
No harm to patient temperatures. approaches which address the cause of
failure/failure mode. Such solutions relate to Transportation Testing
Impact features/ geometry/ materials which provide a has been completed for
No health consequence/ high degree of assurance of robust designs EVO-xx-yy-zz-D devices
Nuisance to patient or end user established effective through clinical use. per ref: VAL07-0011
REPORT3 Rev 0
RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' xx-yy-zz-D products are
NA 'ADHESIVE: LOCTITE 4013 20GRAM 1 of similar design to EVO- 1 III Yes No N/A
(20268/26073)' xx-yy-zz-E product(s)
tested
Transportation Testing
has been completed for
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
1 Likely III xx-yy-zz-D products are
tested
transportation, the The material of the adhesive is designed to (s) out of 14724 devices
base polymers withstand high temperatures. used in patients over a 3
exposure to high Design solutions employed using state of the art Jul 2017) period.
temperatures. approaches which address the cause of
features/ geometry/ materials which provide a has been completed for
high degree of assurance of robust designs EVO-xx-yy-zz-D devices
established effective through clinical use. 1 per ref: VAL07-0011 1 III Yes No N/A
REPORT3 Rev 0
NA 'ADHESIVE: LOCTITE 4013 20GRAM of similar design to EVO-
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
Risk Control History shows 0 failure
During The adhesive material is designed to have (s) out of 14724 devices
transportation, the minimal contraction at low temperatures. used in patients over a 3
adhesive contracts year (03 Jul 2014 to 03
due to low Design solutions employed using state of the art Jul 2017) period.
temperatures. It is approaches which address the cause of
subject to failure/failure mode. Such solutions relate to Transportation Testing
mechanical stress features/ geometry/ materials which provide a has been completed for
because it high degree of assurance of robust designs EVO-xx-yy-zz-D devices
becomes established effective through clinical use. per ref: VAL07-0011
constrained by REPORT3 Rev 0
surrounding Implementation EVO-xx-yy-zz-C & EVO-
components. RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' xx-yy-zz-D products are
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
transportation, the The adhesive material is designed to have (s) out of 14724 devices
adhesive expands minimal contraction at low temperatures. used in patients over a 3
due to high year (03 Jul 2014 to 03
temperatures. It is Design solutions employed using state of the art Jul 2017) period.
subject to approaches which address the cause of
mechanical stress failure/failure mode. Such solutions relate to Transportation Testing
because it features/ geometry/ materials which provide a has been completed for
becomes high degree of assurance of robust designs EVO-xx-yy-zz-D devices
constrained by established effective through clinical use. per ref: VAL07-0011
surrounding REPORT3 Rev 0
components. Implementation EVO-xx-yy-zz-C & EVO-
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
the components The material of the components in contact with (s) out of 14724 devices
surrounding the the adhesive are designed to have minimal used in patients over a 3
adhesive expand expansion at temperature and humidity of year (03 Jul 2014 to 03
due to the heat and sterilisation 1 Jul 2017) period. 1 III Yes No N/A
humidity of that
process. The joint Design solutions employed using state of the art
becomes subjected approaches which address the cause of Simulated Use Testing
to mechanical failure/failure mode. Such solutions relate to has been completed for
Min
Has risk
Probability Is a
of Risk ?
?
Control
stress. features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
established effective through clinical use. per ref: NCT16-0036-R
Ver 0
RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' products are of similar
NA 'ADHESIVE: LOCTITE 4013 20GRAM design to EVO-xx-yy-zz-
(20268/26073)' C product(s) tested
polymer degrades The material of the adhesive is designed to be (s) out of 14724 devices
due to exposure to stable when exposed to light. used in patients over a 3
light. year (03 Jul 2014 to 03
Design solutions employed using state of the art Jul 2017) period.
failure/failure mode. Such solutions relate to 25 Months Realtime
features/ geometry/ materials which provide a Aging has been
high degree of assurance of robust designs 1 completed for EVO-xx- 1 III Yes No N/A
established effective through clinical use. yy-zz-D and EVO-xx-yy-
zz-C devices per ref:
Implementation VAL08-0048 REPORT 2
RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' Rev 0
NA 'ADHESIVE: LOCTITE 4013 20GRAM EVO-xx-yy-zz-D
(20268/26073)' products are of similar
C product(s) tested
due to exposure to stable when exposed to oxygen. used in patients over a 3
oxygen. year (03 Jul 2014 to 03
C product(s) tested
adhesive absorbs The material of the adhesive is designed to be (s) out of 14724 devices
additional moisture stable when exposed to moisture. used in patients over a 3
and expands. It is year (03 Jul 2014 to 03
subject to Design solutions employed using state of the art Jul 2017) period.
mechanical stress approaches which address the cause of
because it failure/failure mode. Such solutions relate to 25 Months Realtime
becomes features/ geometry/ materials which provide a Aging has been
constrained by high degree of assurance of robust designs 1 completed for EVO-xx- 1 III Yes No N/A
surrounding established effective through clinical use. yy-zz-D and EVO-xx-yy-
components. zz-C devices per ref:
C product(s) tested
Adhesive cracked but transportation, the The material of the adhesive is designed to (s) out of 14724 devices
components do not come apart base polymers withstand low temperatures. used in patients over a 3
until device is inside the body. degrades due to year (03 Jul 2014 to 03
Device withdrawn. Replacement exposure to low Design solutions employed using state of the art Jul 2017) period.
device required temperatures. approaches which address the cause of
2 Likely IIA failure/failure mode. Such solutions relate to 1 Transportation Testing 1 IIA Yes No N/A
Harm features/ geometry/ materials which provide a has been completed for
Additional exposure to sedation, high degree of assurance of robust designs EVO-xx-yy-zz-D devices
radiation and/or contrast established effective through clinical use. per ref: VAL07-0011
REPORT3 Rev 0
Impact Implementation EVO-xx-yy-zz-C & EVO-
Min
Has risk
Probability Is a
of Risk ?
?
Control
Temporary discomfort- medical RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' xx-yy-zz-D products are
intervention not required NA 'ADHESIVE: LOCTITE 4013 20GRAM of similar design to EVO-
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
REPORT3 Rev 0
NA 'ADHESIVE: LOCTITE 4013 20GRAM 1 of similar design to EVO- 1 IIA Yes No N/A
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
transportation, the The adhesive material is designed to have 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
due to the heat and sterilisation Jul 2017) period.
humidity of that
to mechanical failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
Ver 0
high degree of assurance of robust designs 1 completed for EVO-xx- 1 IIA Yes No N/A
C product(s) tested
features/ geometry/ materials which provide a 1 Aging has been 1 IIA Yes No N/A
high degree of assurance of robust designs completed for EVO-xx-
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
constrained by high degree of assurance of robust designs 1 completed for EVO-xx- 1 IIA Yes No N/A
C product(s) tested
The component expels naturally. exposure to low Design solutions employed using state of the art Jul 2017) period.
Harm failure/failure mode. Such solutions relate to Transportation Testing
No retrieval required. features/ geometry/ materials which provide a has been completed for
Impact established effective through clinical use. per ref: VAL07-0011
No health consequence/ REPORT3 Rev 0
Nuisance to patient or end user Implementation EVO-xx-yy-zz-C & EVO-
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
1 Likely III tested
REPORT3 Rev 0
RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' 1 xx-yy-zz-D products are 1 III Yes No N/A
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
humidity of that
to mechanical failure/failure mode. Such solutions relate to 1 has been completed for 1 III Yes No N/A
Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
C product(s) tested
constrained by high degree of assurance of robust designs 1 completed for EVO-xx- 1 III Yes No N/A
C product(s) tested
Device requires endoscopic exposure to low Design solutions employed using state of the art Jul 2017) period.
removal. temperatures. approaches which address the cause of
Harm features/ geometry/ materials which provide a has been completed for
Foreign body / matter left in high degree of assurance of robust designs EVO-xx-yy-zz-D devices
patient which can be retrieved 3 Likely IIB established effective through clinical use. 1 per ref: VAL07-0011 1 IIA Yes No N/A
within the same procedure. REPORT3 Rev 0
Impact RMS0084 'ADHESIVE: LOCTITE 4061 (15544)' xx-yy-zz-D products are
Harm requiring medical NA 'ADHESIVE: LOCTITE 4013 20GRAM of similar design to EVO-
intervention, within the same (20268/26073)' xx-yy-zz-E product(s)
operating procedure. No further tested
hospital stay required Transportation Testing
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL07-0012
REPORT3 Rev 0
tested
REPORT3 Rev 0
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
subject to approaches which address the cause of 1 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
humidity of that
to mechanical failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
Ver 0
C product(s) tested
C product(s) tested
adhesive absorbs The material of the adhesive is designed to be 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
constrained by high degree of assurance of robust designs completed for EVO-xx-
C product(s) tested
1.2.4. Metal components are Situation During Risk Control History shows 0 failure
damaged/distorted before use Mechanical integrity of the metal transportation/stora The materials of the components (s) out of 14724 devices
components is compromised ge, the metal (Nitinol/SS/Tantalum/Aluminium/Barium) are used in patients over a 3
before procedure. components designed to have minimal dimensional variation at year (03 Jul 2014 to 03
contract due to low low temperatures. Jul 2017) period.
Harm temperatures.
Device replaced Device is subject to Design solutions employed using state of the art Transportation Testing
without a health thermal stress approaches which address the cause of has been completed for
consequence. and/or mechanical failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
stress because it features/ geometry/ materials which provide a per ref: VAL07-0011
Impact becomes high degree of assurance of robust designs REPORT3 Rev 0
No health consequence/ constrained by established effective through clinical use. EVO-xx-yy-zz-C & EVO-
Nuisance to patient or end user surrounding xx-yy-zz-D products are
components. Implementation of similar design to EVO-
tested
EVO-xx-yy-zz-D and
1 1 III Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
completed for EVO-xx-
1 Likely III
yy-zz-D and EVO-xx-yy-
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
transportation/stora The materials of the components (s) out of 14724 devices
ge, the metal (Nitinol/SS/Tantalum/Aluminium/Barium) are used in patients over a 3
components designed to have minimal dimensional variation at year (03 Jul 2014 to 03
expand due to high high temperatures. Jul 2017) period.
temperatures.
Device is subject to Design solutions employed using state of the art Transportation Testing
thermal stress approaches which address the cause of has been completed for
and/or mechanical failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
becomes high degree of assurance of robust designs 1 REPORT3 Rev 0 1 III Yes No N/A
constrained by established effective through clinical use. EVO-xx-yy-zz-C & EVO-
surrounding xx-yy-zz-D products are
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
temperatures.
becomes high degree of assurance of robust designs REPORT3 Rev 0
tested
EVO-xx-yy-zz-D and
1 1 III Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
Mechanical integrity of the metal transportation/stora The materials of the components (s) out of 14724 devices
components is compromised. ge, the metal (Nitinol/SS/Tantalum/Aluminium/Barium) are used in patients over a 3
Inability to fully deploy stent components designed to have minimal dimensional variation at year (03 Jul 2014 to 03
during procedure. Replacement contract due to low low temperatures. Jul 2017) period.
device required temperatures.
Harm thermal stress approaches which address the cause of has been completed for
Additional exposure to sedation, and/or mechanical failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
radiation and/or contrast 2 Likely IIA stress because it features/ geometry/ materials which provide a 1 per ref: VAL07-0011 1 IIA Yes No N/A
Impact constrained by established effective through clinical use. EVO-xx-yy-zz-C & EVO-
Temporary discomfort- medical surrounding xx-yy-zz-D products are
intervention not required components. Implementation of similar design to EVO-
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
temperatures.
tested
EVO-xx-yy-zz-D and
1 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
temperatures.
thermal stress approaches which address the cause of 1 has been completed for 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
Mechanical integrity of the metal transportation/stora The materials of the components (s) out of 14724 devices
components is compromised. ge, the metal (Nitinol/SS/Tantalum/Aluminium/Barium) are used in patients over a 3
Inability to fully recapture stent components designed to have minimal dimensional variation at year (03 Jul 2014 to 03
during procedure. Replacement contract due to low low temperatures. Jul 2017) period.
device required temperatures.
Harm thermal stress approaches which address the cause of has been completed for
Minor trauma to mucosa and/or mechanical failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D devices
Impact becomes high degree of assurance of robust designs REPORT3 Rev 0
Temporary discomfort- medical constrained by established effective through clinical use. EVO-xx-yy-zz-C & EVO-
intervention not required surrounding xx-yy-zz-D products are
tested
EVO-xx-yy-zz-D and
1 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
2 Likely IIA xx-yy-zz-E product(s)
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
temperatures.
Device is subject to Design solutions employed using state of the art 1 Transportation Testing 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
temperatures.
tested
EVO-xx-yy-zz-D and
1 1 IIA Yes No N/A
per ref: VAL07-0012
REPORT3 Rev 0
tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
1.2.5. Stent fractured before use Situation Over time the stent Risk Control History shows 0 failure
Inability to commence stent material corrodes Stent materials are nitinol as specified by design. (s) out of 14724 devices
deployment. Replacement device due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
required. oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
1 Likely III degrade over time. 1 Jul 2017) period. 1 III Yes No N/A
Harm
No harm to patient Design solutions employed using state of the art Simulated Use Testing
approaches which address the cause of post 25 months realtime
Impact failure/failure mode. Such solutions relate to aging (post VAL08-0048)
Min
Has risk
Probability Is a
of Risk ?
?
Control
No health consequence/ features/ geometry/ materials which provide a has been completed for
Nuisance to patient or end user high degree of assurance of robust designs EVO-xx-yy-zz-D and
per ref: VAL08-0049
Implementation REPORT 2 Rev 0
DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
DWG0289 'Colonic Stent' products are of similar
C product(s) tested
the stent expands Stent materials are nitinol as specified by design. (s) out of 14724 devices
due to heat and Nitinol material is superelastic and are compatible used in patients over a 3
humidity of that with sterilisation conditions. year (03 Jul 2014 to 03
process. It is Jul 2017) period.
subject to Design solutions employed using state of the art
because it failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
becomes features/ geometry/ materials which provide a
constrained by high degree of assurance of robust designs
surrounding established effective through clinical use.
components.
Implementation
Situation Over time the stent Risk Control History shows 0 failure
Stent fracture during deployment. material corrodes Stent materials are nitinol as specified by design. (s) out of 14724 devices
Wire penetrates stricture wall. due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
wall. oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
degrade over time. Jul 2017) period.
Harm
Perforation and/or minor bleed Design solutions employed using state of the art Simulated Use Testing
(self-limited) approaches which address the cause of post 25 months realtime
failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
Harm requiring medical high degree of assurance of robust designs EVO-xx-yy-zz-D and
intervention, within the same established effective through clinical use. EVO-xx-yy-zz-C devices
operating procedure. No further per ref: VAL08-0049
hospital stay required Implementation REPORT 2 Rev 0
3 Likely IIB design to EVO-xx-yy-zz-
C product(s) tested
because it failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
components.
Implementation
Wire does not penetrate stricture due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
wall. oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
degrade over time. Jul 2017) period.
Harm
Minor trauma to mucosa Design solutions employed using state of the art Simulated Use Testing
2 Likely IIA approaches which address the cause of 1 post 25 months realtime 1 IIA Yes No N/A
Impact failure/failure mode. Such solutions relate to aging (post VAL08-0048)
Temporary discomfort- medical features/ geometry/ materials which provide a has been completed for
intervention not required high degree of assurance of robust designs EVO-xx-yy-zz-D and
per ref: VAL08-0049
Implementation REPORT 2 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
components.
Implementation
Multiple wire fractures that can due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
occur at different sites. Wire(s) oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
penetrates stricture wall. degrade over time. Jul 2017) period.
Harm Design solutions employed using state of the art Simulated Use Testing
Perforation (medical intervention approaches which address the cause of post 25 months realtime
required) and/or major bleed failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
(transfusion required) features/ geometry/ materials which provide a has been completed for
Impact established effective through clinical use. EVO-xx-yy-zz-C devices
Harm requiring secondary per ref: VAL08-0049
intervention and/ or prolonged Implementation REPORT 2 Rev 0
hospitalisation required DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
4 Unlikely IIB design to EVO-xx-yy-zz-
C product(s) tested
components.
Implementation
do not penetrate stricture wall. degrade over time. Jul 2017) period.
Non-uniform expansion of stent.
Replacement device required Design solutions employed using state of the art Simulated Use Testing
Harm failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
Minor trauma to mucosa 2 Likely IIA features/ geometry/ materials which provide a has been completed for
Temporary discomfort- medical per ref: VAL08-0049
intervention not required Implementation REPORT 2 Rev 0
C product(s) tested
During sterilisation, Risk Control 1 History shows 0 failure 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
because it failure/failure mode. Such solutions relate to
components.
Implementation
do not penetrate stricture wall. degrade over time. Jul 2017) period.
Non-uniform expansion of stent.
Immediate stent migration Design solutions employed using state of the art Simulated Use Testing
Harm failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
Foreign body / matter left in features/ geometry/ materials which provide a has been completed for
patient which can be retrieved high degree of assurance of robust designs EVO-xx-yy-zz-D and
within the same procedure. established effective through clinical use. EVO-xx-yy-zz-C devices
per ref: VAL08-0049
Impact Implementation REPORT 2 Rev 0
Harm requiring medical DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
intervention, within the same DWG0289 'Colonic Stent' products are of similar
operating procedure. No further 3 Likely IIB design to EVO-xx-yy-zz-
hospital stay required C product(s) tested
components.
Implementation
Wire protrudes towards stent due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
lumen impacting on Enteric oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
contents. degrade over time. Jul 2017) period.
Harm Design solutions employed using state of the art Simulated Use Testing
Reocclusion occurs, requiring approaches which address the cause of post 25 months realtime
secondary intervention failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
Impact high degree of assurance of robust designs EVO-xx-yy-zz-D and
Harm requiring secondary established effective through clinical use. EVO-xx-yy-zz-C devices
intervention and/ or prolonged 4 Unlikely IIB per ref: VAL08-0049
hospitalisation required Implementation REPORT 2 Rev 0
C product(s) tested
humidity of that with sterilisation conditions. 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
because it failure/failure mode. Such solutions relate to
components.
Implementation
Wire protrudes towards stent due to exposure to Nitinol material develops an oxide layer in air, used in patients over a 3
lumen. Introducer tip snags on oxygen which protects it from corrosion and do not year (03 Jul 2014 to 03
stent during recapture, displacing degrade over time. Jul 2017) period.
stent.
Design solutions employed using state of the art Simulated Use Testing
Harm approaches which address the cause of post 25 months realtime
Continuation of occlusion (which failure/failure mode. Such solutions relate to aging (post VAL08-0048)
1 1 IIA Yes No N/A
can be treated within the same features/ geometry/ materials which provide a has been completed for
procedure) high degree of assurance of robust designs EVO-xx-yy-zz-D and
Impact per ref: VAL08-0049
Harm requiring medical Implementation REPORT 2 Rev 0
intervention, within the same DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
operating procedure. No further DWG0289 'Colonic Stent' products are of similar
hospital stay required 3 Likely IIB design to EVO-xx-yy-zz-
C product(s) tested
components.
Implementation
1.3. Device 1.3.1. Delivery system component Situation Incorrect Materials: Risk Control History shows 0 failure
componen materials degrade during the Cannot perform procedure. Materials Device materials are engineered plastics and (s) out of 14724 devices
ts must be procedure. Device does not function as incompatible with metals that are chosen because they are used in patients over a 3
compatibl (patient contacting) intended. intended compatible with intended physiological year (03 Jul 2014 to 03
e for use physiological environment Jul 2017) period.
with the Harm environment.
intended No harm to patient or end user Design solutions employed using state of the art
physiologi 1 Likely III approaches which address the cause of 1 1 III Yes No N/A
cal Impact failure/failure mode. Such solutions relate to
environme No health consequence/ features/ geometry/ materials which provide a
nt Nuisance to patient or end user high degree of assurance of robust designs
established effective through clinical use.
Implementation
Situation Incorrect Materials: Risk Control History shows 0 failure
Cannot perform procedure. Materials Device materials are engineered plastics and (s) out of 14724 devices
Device does not function as incompatible with metals that are chosen because they are used in patients over a 3
intended. intended compatible with intended physiological year (03 Jul 2014 to 03
physiological environment Jul 2017) period.
Harm environment.
Additional exposure to sedation, Design solutions employed using state of the art
radiation and/or contrast 2 Likely IIA approaches which address the cause of 1 1 IIA Yes No N/A
failure/failure mode. Such solutions relate to
Impact features/ geometry/ materials which provide a
Temporary discomfort- medical high degree of assurance of robust designs
intervention not required established effective through clinical use.
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
Components detach from device Materials Device materials are engineered plastics and (s) out of 14724 devices
during procedure. Foreign body incompatible with metals that are chosen because they are used in patients over a 3
left in patient intended compatible with intended physiological year (03 Jul 2014 to 03
physiological environment Jul 2017) period.
Harm environment.
Foreign body / matter left in Design solutions employed using state of the art
patient which can be retrieved 3 Likely IIB approaches which address the cause of 1 1 IIA Yes No N/A
within the same procedure. failure/failure mode. Such solutions relate to
features/ geometry/ materials which provide a
Impact high degree of assurance of robust designs
Harm requiring medical established effective through clinical use.
intervention, within the same
operating procedure. No further Implementation
hospital stay required DWG0497 'TTS SEMS Assembly'
Components detach from device Materials Device materials are engineered plastics and (s) out of 14724 devices
during procedure. Foreign body incompatible with metals that are chosen because they are used in patients over a 3
left in patient and expels intended compatible with intended physiological year (03 Jul 2014 to 03
naturally. physiological environment Jul 2017) period.
environment.
No retrieval required. 1 Likely III approaches which address the cause of 1 1 III Yes No N/A
No health consequence/ high degree of assurance of robust designs
Nuisance to patient or end user established effective through clinical use.
Implementation
1.4. Device 1.4.1. Device materials deteriorate or Situation Device materials Risk Control History shows 0 failure
materials joints break during deployment. Components detach from device. not compatible with Device materials are engineered plastics and (s) out of 14724 devices
must be Device does not function as contrast media. metals that are compatible for use with contrast used in patients over a 3
compatibl intended. media. year (03 Jul 2014 to 03
e with Jul 2017) period.
procedural Harm Design solutions employed using state of the art
fluids. Additional exposure to sedation, approaches which address the cause of
2 Likely IIA 1 1 IIA Yes No N/A
radiation and/or contrast failure/failure mode. Such solutions relate to
Temporary discomfort- medical established effective through clinical use.
intervention not required
Implementation
Situation Device materials Risk Control History shows 0 failure
Components detach from device not compatible with Device materials are engineered plastics and (s) out of 14724 devices
contrast media. metals that are compatible for use with contrast used in patients over a 3
Harm media. year (03 Jul 2014 to 03
Foreign body / matter left in Jul 2017) period.
patient which can be retrieved Design solutions employed using state of the art
within the same procedure. approaches which address the cause of
3 Likely IIB 1 1 IIA Yes No N/A
Harm requiring medical high degree of assurance of robust designs
intervention, within the same established effective through clinical use.
operating procedure. No further
hospital stay required Implementation
2. Implanted 2.1. Must be 2.1.1. Implant artefact obscures region Situation Patient requires Risk Control History shows 0 failure
device compatibl of interest during MRI (Reciprocal User unable to visualise MRI scan in the Stent materials are nitinol and tantalum. Nitinol (s) out of 14724 devices
e with MRI interference) anatomical region of interest. A implant region and Tantalum are non-ferromagnetic but are used in patients over a 3
different imaging technique must following initial paramagnetic. Both materials can produce a year (03 Jul 2014 to 03
be used to visualise the region of procedure. small artefact but minimise the local magnetic Jul 2017) period.
interest. field in the MR environment.
2 Likely IIA Engineering experience/guidance gained from 1 MRI Testing has been 1 IIA Yes No N/A
other products used to determine material completed for EVO-xx-
Harm selection. yy-zz-D devices per ref:
Additional exposure to sedation, TST10-053
radiation and/or contrast Design solutions employed using state of the art MRI Testing has been
approaches which address the cause of completed for EVO-xx-
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact failure/failure mode. Such solutions relate to yy-zz-C devices per ref:
Temporary discomfort- medical features/ geometry/ materials which provide a TST11-067
intervention not required high degree of assurance of robust designs
Implementation
2.1.2. Implant heats during MRI scan. Situation Patient requires Risk Control History shows 0 failure
(Reciprocal interference) Patient receives an MRI scan MRI scan in the Implant design (material and geometry) is such (s) out of 14724 devices
where the scan region is implant region that temperature increase is acceptable. used in patients over a 3
continuously focused on a following initial year (03 Jul 2014 to 03
stented location, the scan length procedure Engineering experience/guidance gained from Jul 2017) period.
is prolonged and the MRI other products used to determine material
equipment settings are set at a selection. MRI Testing has been
maximum level of intensity. This completed for EVO-xx-
MR environment will induce yy-zz-D devices per ref:
heating in the stent material. Design solutions employed using state of the art 1 TST10-053
approaches which address the cause of MRI Testing has been
Harm failure/failure mode. Such solutions relate to completed for EVO-xx-
Minor trauma to mucosa features/ geometry/ materials which provide a yy-zz-C devices per ref:
high degree of assurance of robust designs TST11-067
Impact established effective through clinical use.
Temporary discomfort- medical
intervention not required Implementation
2 Likely IIA DWG0288 'Enteral Stent ' 1 IIA Yes No N/A
Risk Control The effectiveness is
IFU details acceptable MRI machine settings . inherent in the risk
(Patient card has reference to MR conditionality) control
Device information - Instructions for Use. This

serves to disclose to the user operating principles.
Device Information- Labelling/Instructions for Use

3
(IFU) indicate to the user device usage details/
operating principles, but cannot guarantee they
will utilise the information
Implementation
IFU0053- Evolution™ Duodenal Stent System
IFU0052- Evolution™ Colonic Stent System
CHT0018 'Patient/ Doctor Record Card'
2.1.3. Implant torques during MRI scan Situation Patient requires Risk Control History shows 0 failure
(Reciprocal interference) Patient receives an MRI scan MRI scan in the Implant design (material and geometry) is such (s) out of 14724 devices
where the scan region is implant region that susceptibility to torque is acceptable . used in patients over a 3
continuously focused on a following initial year (03 Jul 2014 to 03
stented location, the scan length procedure Engineering experience/guidance gained from Jul 2017) period.
is prolonged and the MRI other products used to determine material
equipment settings are set at a selection. MRI Testing has been
maximum level of intensity. This completed for EVO-xx-
MR environment causes a force yy-zz-D devices per ref:
to be applied to the stent when Design solutions employed using state of the art 1 TST10-053
local magnetic field in stent approaches which address the cause of MRI Testing has been
material attempts to orientate failure/failure mode. Such solutions relate to completed for EVO-xx-
with magnetic field of MR features/ geometry/ materials which provide a yy-zz-C devices per ref:
System. high degree of assurance of robust designs TST11-067
2 Likely IIA established effective through clinical use. 1 IIA Yes No N/A
Harm
Minor trauma to mucosa Implementation
Impact DWG0289 'Colonic Stent'
intervention not required Risk Control The effectiveness is
control
serves to disclose to the user operating principles. 3
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
2.1.4. Implant deflects during MRI Situation Patient requires Risk Control History shows 0 failure
The scan region is continuously MRI scan in the Implant design (material and geometry) is such (s) out of 14724 devices
focused on a stented location, implant region that susceptibility to deflection is acceptable . used in patients over a 3
the scan length is prolonged and following initial year (03 Jul 2014 to 03
the MRI equipment settings are procedure Engineering experience/guidance gained from Jul 2017) period.
set at a maximum level of other products used to determine material
intensity. This MR environment selection. MRI Testing has been
causes force to be applied to the completed for EVO-xx-
stent when local magnetic field in yy-zz-D devices per ref:
stent material is exposed to Design solutions employed using state of the art 1 TST10-053
spatial gradient of static magnetic approaches which address the cause of MRI Testing has been
field of MR System. failure/failure mode. Such solutions relate to completed for EVO-xx-
features/ geometry/ materials which provide a yy-zz-C devices per ref:
Harm high degree of assurance of robust designs TST11-067
Minor trauma to mucosa established effective through clinical use.
Impact 2 Likely IIA Implementation 1 IIA Yes No N/A

Temporary discomfort- medical DWG0288 'Enteral Stent '
intervention not required DWG0289 'Colonic Stent'
control
serves to disclose to the user operating principles.

3
Implementation
3. Overall device 3.1. Allow 3.1.1. Can not readily prepare device for Situation Incorrect materials Risk Control History shows 0 failure
device disposal Device components separate selected. Device Materials selected for the device have the ability (s) out of 14724 devices
disposal. during disposal. materials are too to be compressed/coiled for disposal. used in patients over a 3
rigid to year (03 Jul 2014 to 03
Harm compress/coil up Design solutions employed using state of the art Jul 2017) period.
No harm to patient or end user for disposal. approaches which address the cause of
1 Likely III failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Implementation
4. Packaging 4.1. Remain 4.1.1. Label detaches from packaging Situation Bond strength of Risk Control History shows 0 failure
(Packaging and joined. before use. Device cannot be used. Label to packaging The label material (ZPerform (s) out of 14724 devices
Label). Replacement device required is too low. 1000T) includes a silicone-based, oil-free used in patients over a 3
adhesive that sufficiently bonds the Label to the year (03 Jul 2014 to 03
Harm packaging. Jul 2017) period.
No harm to patient
Impact Design solutions employed using state of the art Simulated Use Testing
No health consequence/ approaches which address the cause of has been completed for
1 1 III Yes No N/A
Nuisance to patient or end user failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
1 Likely III features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
high degree of assurance of robust designs per ref: NCT16-0036-R
established effective through clinical use. Ver 0
EVO-xx-yy-zz-D
RMS0207 'PRISYM LABELS RMN 90-307'' design to EVO-xx-yy-zz-
CHT0037 'Specification for Packaging Boxes' C product(s) tested
Material degrades Risk Control History shows 0 failure
during exposure to The label material (ZPerform 1 (s) out of 14724 devices 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
heat and humidity 1000T) includes a silicone-based, oil-free used in patients over a 3
of sterilisation. adhesive that is compatible with EtO sterilisation. year (03 Jul 2014 to 03
Jul 2017) period.
failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
EVO-xx-yy-zz-D
CHT0037 'Specification for Packaging Boxes' C product(s) tested
Materials degrade Risk Control History shows 0 failure
over time. The label material (ZPerform (s) out of 14724 devices
1000T) includes a silicone-based, oil-free used in patients over a 3
adhesive that is stable over time. year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of Product Condition
failure/failure mode. Such solutions relate to testing post 25 months
features/ geometry/ materials which provide a realtime aging (post
high degree of assurance of robust designs VAL08-0048) has been
established effective through clinical use. completed for EVO-xx-
Implementation zz-C devices per ref:
RMS0207 'PRISYM LABELS RMN 90-307'' VAL08-0049 REPORT 2
CHT0037 'Specification for Packaging Boxes' Rev 0
DWG0009 'Packaging Pouches' 1 EVO-xx-yy-zz-D 1 III Yes No N/A
C product(s) tested
Simulated Use Testing
post 25 months realtime
aging (post VAL08-0048)
EVO-xx-yy-zz-D and
per ref: VAL08-0049
REPORT 2 Rev 0
EVO-xx-yy-zz-D
C product(s) tested
Material degrades The label material (ZPerform (s) out of 14724 devices
during 1000T) includes a silicone-based, oil-free used in patients over a 3
transportation. adhesive that is stable during expected year (03 Jul 2014 to 03
transportation conditions. Jul 2017) period.
Design solutions employed using state of the art EVO-xx-yy-zz-D devices
approaches which address the cause of per ref: VAL07-0011
failure/failure mode. Such solutions relate to REPORT3 Rev 0
features/ geometry/ materials which provide a EVO-xx-yy-zz-C & EVO-
high degree of assurance of robust designs xx-yy-zz-D products are
established effective through clinical use. 1 of similar design to EVO- 1 III Yes No N/A
Implementation tested
RMS0207 'PRISYM LABELS RMN 90-307'' Transportation Testing
CHT0037 'Specification for Packaging Boxes' has been completed for
DWG0009 'Packaging Pouches' EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
5. Packaging 5.1. Remain 5.1.1. IFU Pouch detaches from the Situation Bond strength of Risk Control History shows 0 failure
(Packaging and joined. packaging before use. IFU Pouch retrieved inside IFU Pouch to The IFU Pouch material includes an adhesive that (s) out of 14724 devices
IFU Pouch). Protective Packaging. packaging is too sufficiently bonds the IFU Pouch to the used in patients over a 3
low. packaging. year (03 Jul 2014 to 03
Harm Jul 2017) period.
no harm to patient
No health consequence/ approaches which address the cause of 1 has been completed for 1 III Yes No N/A
EVO-xx-yy-zz-D
DWG0009 'Packaging Pouches' design to EVO-xx-yy-zz-
RMS0151 'IFU Specification Document' C product(s) tested
during exposure to The IFU Pouch material includes an adhesive that (s) out of 14724 devices
heat and humidity is compatible with EtO sterilisation. used in patients over a 3
of sterilisation. year (03 Jul 2014 to 03
Jul 2017) period.
DWG0009 'Packaging Pouches' EVO-xx-yy-zz-D
RMS0151 'IFU Specification Document' products are of similar
C product(s) tested
1 Likely III over time. The IFU Pouch material includes an adhesive that (s) out of 14724 devices
sufficiently bonds the IFU Pouch to the packaging used in patients over a 3
and is stable over time. year (03 Jul 2014 to 03
Jul 2017) period.

approaches which address the cause of Simulated Use Testing
Ver 0
1 1 III Yes No N/A
RMS0151 'IFU Specification Document' design to EVO-xx-yy-zz-
C product(s) tested
25 Months Realtime
Aging has been
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
during The IFU Pouch material includes an adhesive that (s) out of 14724 devices
transportation. is stable during expected transportation used in patients over a 3
conditions. year (03 Jul 2014 to 03
1 Jul 2017) period. 1 III Yes No N/A
approaches which address the cause of Transportation Testing
Min
Has risk
Probability Is a
of Risk ?
?
Control
features/ geometry/ materials which provide a EVO-xx-yy-zz-D devices
high degree of assurance of robust designs per ref: VAL07-0011
established effective through clinical use. REPORT3 Rev 0
RMS0151 'IFU Specification Document' xx-yy-zz-E product(s)
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
Situation Bond strength of Risk Control History shows 0 failure
IFU Pouch cannot be retrieved. IFU Pouch to The IFU Pouch material includes an adhesive that (s) out of 14724 devices
Replacement device required. packaging is too sufficiently bonds the IFU Pouch to the used in patients over a 3
low. packaging. year (03 Jul 2014 to 03
No harm to patient
No health consequence/ approaches which address the cause of 1 has been completed for 1 III Yes No N/A
EVO-xx-yy-zz-D
during exposure to The IFU Pouch material includes an adhesive that (s) out of 14724 devices
heat and humidity is compatible with EtO sterilisation. used in patients over a 3
of sterilisation. year (03 Jul 2014 to 03
Jul 2017) period.
1 Likely III high degree of assurance of robust designs EVO-xx-yy-zz-D and
DWG0009 'Packaging Pouches' EVO-xx-yy-zz-D
C product(s) tested
over time. The IFU Pouch material includes an adhesive that (s) out of 14724 devices
sufficiently bonds the IFU Pouch to the packaging used in patients over a 3
and is stable over time. year (03 Jul 2014 to 03
Jul 2017) period.

features/ geometry/ materials which provide a 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
Ver 0
RMS0151 'IFU Specification Document' design to EVO-xx-yy-zz-
C product(s) tested
25 Months Realtime
Aging has been
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
during The IFU Pouch material includes an adhesive that (s) out of 14724 devices
transportation. is stable during expected transportation used in patients over a 3
conditions. year (03 Jul 2014 to 03
Jul 2017) period.
DWG0009 'Packaging Pouches' 1 of similar design to EVO- 1 III Yes No N/A
RMS0151 'IFU Specification Document' xx-yy-zz-E product(s)
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
6. Packaging 6.1. Allow EtO 6.1.1. Sterilising agent (EtO) cannot Situation Pore size of Risk Control History shows 0 failure
(Sterile Barrier sterilisatio pass through Sterile Barrier Contents not sterilised, microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
System & n. System and contents before use. Contamination introduced into too low. membrane. This material is porous and allows the used in patients over a 3
contents) patient causing infection passage of EtO. year (03 Jul 2014 to 03
Note: The microbial Jul 2017) period.
Note: The Harm barrier means the Design solutions employed using state of the art
Sterile Barrier Infection treatable with property of the approaches which address the cause of Sterilization validation
System means medication sterile barrier failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
the minimum system that features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
package that Impact prevents the high degree of assurance of robust designs EVO-xx-yy-zz-C devices
prevents Harm requiring medical ingress of established effective through clinical use. per ref: VAL07-0083
ingress of intervention, within the same microorganisms EVO-xx-yy-zz-D
microorganisms operating procedure. No further under specified Implementation products are of similar
and allows hospital stay required conditions. DWG0009 'Packaging Pouches' design to EVO-xx-yy-zz-
aseptic C product(s) tested
presentation of
the product at Pore size of Risk Control History shows 0 failure
the point of microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
use. 3 Likely IIB too low. membrane. This material is porous and allows the used in patients over a 3
passage of EtO. year (03 Jul 2014 to 03
barrier means the Design solutions employed using state of the art
property of the approaches which address the cause of Sterilization validation
sterile barrier failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
system that features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
prevents the high degree of assurance of robust designs EVO-xx-yy-zz-C devices
ingress of established effective through clinical use. per ref: VAL07-0083
microorganisms EVO-xx-yy-zz-D
under specified Implementation products are of similar
conditions. DWG0009 'Packaging Pouches' design to EVO-xx-yy-zz-
C product(s) tested
Pore size of Risk Control History shows 0 failure
microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
too low. membrane. This material is porous and allows the 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
sterile barrier failure/failure mode. Such solutions relate to has been completed for
C product(s) tested
Area of microbial Risk Control History shows 0 failure
barrier is too small. Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
membrane. This material has a microporous used in patients over a 3
structure. Therefore any area greater than the year (03 Jul 2014 to 03
microscale will allow the passage of EtO. The Jul 2017) period.
area of the membrane is large enough by design.
Sterilization validation
Design solutions employed using state of the art 1 EVO-xx-yy-zz-D and 1 IIA Yes No N/A
approaches which address the cause of EVO-xx-yy-zz-C devices
failure/failure mode. Such solutions relate to per ref: VAL07-0083
features/ geometry/ materials which provide a EVO-xx-yy-zz-D
high degree of assurance of robust designs products are of similar
established effective through clinical use. design to EVO-xx-yy-zz-
C product(s) tested
Implementation
Insufficient gas Risk Control History shows 0 failure
pathways within The contents and device have clearances that (s) out of 14724 devices
Sterile Barrier allow gas to pass from outside to inside the used in patients over a 3
System to allow device. year (03 Jul 2014 to 03
gas to access Jul 2017) period.
device.
Design solutions employed using state of the art Sterilization validation
1 1 IIA Yes No N/A
established effective through clinical use. EVO-xx-yy-zz-D
Implementation design to EVO-xx-yy-zz-
DWG0009 'Packaging Pouches' C product(s) tested
Situation Pore size of Risk Control History shows 0 failure
Contents not sterilised, microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
Contamination introduced into too low. membrane. This material is porous and allows the used in patients over a 3
patient causing infection passage of EtO. year (03 Jul 2014 to 03
Harm barrier means the Design solutions employed using state of the art
Major Infection property of the approaches which address the cause of Sterilization validation
Impact system that features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
Harm requiring secondary prevents the high degree of assurance of robust designs EVO-xx-yy-zz-C devices
intervention and/ or prolonged ingress of established effective through clinical use. per ref: VAL07-0083
hospitalisation required microorganisms EVO-xx-yy-zz-D
4 Unlikely IIB conditions. DWG0009 'Packaging Pouches' design to EVO-xx-yy-zz-
C product(s) tested
too low. membrane. This material is porous and allows the used in patients over a 3
barrier means the Design solutions employed using state of the art 1 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
C product(s) tested
C product(s) tested
Implementation
device.
1 1 IIA Yes No N/A
Contents not sterilised, microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
Contamination introduced into too low. membrane. This material is porous and allows the used in patients over a 3
patient causing infection passage of EtO. year (03 Jul 2014 to 03
Harm barrier means the Design solutions employed using state of the art
Cross contamination of blood property of the approaches which address the cause of Sterilization validation
borne pathogens / Exposure to sterile barrier failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
pathogens 5 Remote I system that features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
Impact ingress of established effective through clinical use. per ref: VAL07-0083
Permanent irreversible microorganisms EVO-xx-yy-zz-D
impairment, life-threatening under specified Implementation products are of similar
illness or injury conditions. DWG0009 'Packaging Pouches' design to EVO-xx-yy-zz-
C product(s) tested
microbial barrier Tyvek was selected for the Sterile Barrier System 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
C product(s) tested
C product(s) tested
Implementation
device.
1 1 IIA Yes No N/A
6.1.2. Sterilising agent (EtO) cannot be Situation Pore size of Risk Control History shows 0 failure
removed from the device before Sterilising agent (EtO) present in microbial barrier Tyvek was selected for the Sterile Barrier System (s) out of 14724 devices
use. the device. EtO is a genotoxic too low to allow membrane. This material is porous and allows the used in patients over a 3
carcinogen. passage of EtO. passage of EtO. year (03 Jul 2014 to 03
5 Remote I 1 Jul 2017) period. 1 IIA Yes No N/A
Harm
Allergic reaction / toxic or Residual Testing has
immune response Design solutions employed using state of the art been completed for
Min
Has risk
Probability Is a
of Risk ?
?
Control
approaches which address the cause of EVO-xx-yy-zz-D and
Impact failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C devices
Permanent irreversible features/ geometry/ materials which provide a per ref: TST16-061 Ver 1
impairment, life-threatening high degree of assurance of robust designs EVO-xx-yy-zz-C
illness or injury established effective through clinical use. products are of similar
Implementation D product(s) tested
Residual Testing has
been completed for
failure/failure mode. Such solutions relate to per ref: TST16-061 Ver 1
features/ geometry/ materials which provide a EVO-xx-yy-zz-C
D product(s) tested
Implementation
Sterile Barrier allow gas to pass from inside to outside the used in patients over a 3
gas to exit device. Jul 2017) period.
Residual Testing has

Design solutions employed using state of the art been completed for
failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-C devices 1 IIA Yes No N/A
features/ geometry/ materials which provide a per ref: TST16-061 Ver 1
high degree of assurance of robust designs EVO-xx-yy-zz-C
established effective through clinical use. products are of similar
Implementation D product(s) tested
Materials of device Risk Control History shows 0 failure
retain residuals of The materials of the device have minimal porosity (s) out of 14724 devices
sterilising agent. and therefore will not absorb and retain significant used in patients over a 3
amounts of sterilising agent. year (03 Jul 2014 to 03
Jul 2017) period.
Design solutions employed using state of the art Residual Testing has
approaches which address the cause of been completed for
1 1 IIA Yes No N/A
high degree of assurance of robust designs per ref: TST16-061 Ver 1
established effective through clinical use. EVO-xx-yy-zz-C
DWG0009 'Packaging Pouches' D product(s) tested
7. Packaging 7.1. Maintain 7.1.1. Microorganisms pass through Situation Pore size of Risk Control History shows 0 failure
(Sterile Barrier sterility. microbial barrier of Sterile Barrier Microorganisms present in the microbial barrier Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
System). System. device too large. barrier properties and mating compatability. The used in patients over a 3
pore size of the material is low enough to prevent year (03 Jul 2014 to 03
Note: The Harm 5 Remote I the ingress of microorganisms. 1 Jul 2017) period. 1 IIA Yes No N/A
Sterile Barrier Allergic reaction / toxic or
System means immune response Transportation Testing
the minimum has been completed for
package that Impact EVO-xx-yy-zz-D devices
Min
Has risk
Probability Is a
of Risk ?
?
Control
prevents Permanent irreversible Design solutions employed using state of the art per ref: VAL07-0011
ingress of impairment, life-threatening approaches which address the cause of REPORT3 Rev 0
microorganisms illness or injury failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C & EVO-
and allows features/ geometry/ materials which provide a xx-yy-zz-D products are
aseptic high degree of assurance of robust designs of similar design to EVO-
presentation of established effective through clinical use. xx-yy-zz-E product(s)
the product at tested
the point of Implementation
use. DWG0009 'Packaging Pouches'
Microorganisms present in the microbial barrier Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
device too large. barrier properties and mating compatability. The used in patients over a 3
pore size of the material is low enough to prevent year (03 Jul 2014 to 03
Harm the ingress of microorganisms. Jul 2017) period.
Major Infection
Impact has been completed for
Harm requiring secondary EVO-xx-yy-zz-D devices
4 Unlikely IIB 1 1 IIA Yes No N/A
intervention and/ or prolonged Design solutions employed using state of the art per ref: VAL07-0011
hospitalisation required approaches which address the cause of REPORT3 Rev 0
failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C & EVO-
features/ geometry/ materials which provide a xx-yy-zz-D products are
high degree of assurance of robust designs of similar design to EVO-
established effective through clinical use. xx-yy-zz-E product(s)
tested
Implementation
7.1.2. Seal in Sterile Barrier System is Situation Contents of Sterile Risk Control History shows 0 failure
compromised before use. Compromised Microbial seal, Barrier System The contents of the Sterile Barrier System include (s) out of 14724 devices
pathogens are able to enter the have sharp edges rounded corners, which combined with fit and used in patients over a 3
device. or points. double pouching, reduce the risk of penetration. year (03 Jul 2014 to 03
Risk mitigated by product design features / Jul 2017) period.
Harm geometry / materials (design for product use).
Allergic reaction / toxic or Transportation Testing
immune response has been completed for
EVO-xx-yy-zz-D devices
Impact Design solutions employed using state of the art per ref: VAL07-0011
Permanent irreversible approaches which address the cause of REPORT3 Rev 0
1 1 IIA Yes No N/A
impairment, life-threatening failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C & EVO-
illness or injury features/ geometry/ materials which provide a xx-yy-zz-D products are
tested
Implementation
CHT0037 'Specification for Packaging Boxes'
5 Remote I Material degrades Risk Control History shows 0 failure
during exposure to Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
heat and humidity barrier properties and mating compatability. They used in patients over a 3
of sterilisation. are compatible with EtO sterilisation. year (03 Jul 2014 to 03
Jul 2017) period.
1 1 IIA Yes No N/A
CHT0037 'Specification for Packaging Boxes' xx-yy-zz-E product(s)
tested
over time. Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
barrier properties and mating compatability. used in patients over a 3
These materials are stable over time 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
Design solutions employed using state of the art has been completed for
approaches which address the cause of EVO-xx-yy-zz-D devices
features/ geometry/ materials which provide a REPORT3 Rev 0
high degree of assurance of robust designs EVO-xx-yy-zz-C & EVO-
established effective through clinical use. xx-yy-zz-D products are
Implementation xx-yy-zz-E product(s)
during Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
transportation. barrier properties and mating compatability. used in patients over a 3
These materials are stable during expected year (03 Jul 2014 to 03

DWG0009 'Packaging Pouches' xx-yy-zz-E product(s)
CHT0037 'Specification for Packaging Boxes' tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
Situation Contents of Sterile Risk Control History shows 0 failure
Compromised Microbial seal, Barrier System The contents of the Sterile Barrier System include (s) out of 14724 devices
pathogens are able to enter the have sharp edges rounded corners, which combined with fit and used in patients over a 3
device. or points. double pouching, reduce the risk of penetration. year (03 Jul 2014 to 03
Risk mitigated by product design features / Jul 2017) period.
Harm geometry / materials (design for product use).
Major Infection Transportation Testing
Impact EVO-xx-yy-zz-D devices
Harm requiring secondary Design solutions employed using state of the art per ref: VAL07-0011
intervention and/ or prolonged approaches which address the cause of REPORT3 Rev 0
1 1 IIA Yes No N/A
hospitalisation required failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C & EVO-
features/ geometry/ materials which provide a xx-yy-zz-D products are
tested
Implementation
4 Unlikely IIB DWG0009 'Packaging Pouches'
during exposure to Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
heat and humidity barrier properties and mating compatability. They used in patients over a 3
of sterilisation. are compatible with EtO sterilisation. year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of 1 Transportation Testing 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
CHT0037 'Specification for Packaging Boxes' xx-yy-zz-E product(s)
tested
over time. Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
barrier properties and mating compatability. used in patients over a 3
These materials are stable over time year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of 1 EVO-xx-yy-zz-D devices 1 IIA Yes No N/A
Implementation xx-yy-zz-E product(s)
during Tyvek and PET/PE were selected for their sterile (s) out of 14724 devices
transportation. barrier properties and mating compatability. used in patients over a 3
These materials are stable during expected year (03 Jul 2014 to 03

DWG0009 'Packaging Pouches' xx-yy-zz-E product(s)
CHT0037 'Specification for Packaging Boxes' tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
8. Packaging 8.1. Provide 8.1.1. Object punctures through Situation Materials of Risk Control History shows 0 failure
(Protective protection. Protective Packaging and Sterile Protective Packaging and Sterile protective The protective packaging consists of the following (s) out of 14724 devices
Packaging and Barrier System is ripped open Barrier are compromised. packaging are too Design Elements that prevent objects ripping the used in patients over a 3
Sterile Barrier before use. Replacement device required thin. Sterile Barrier System before use; year (03 Jul 2014 to 03
System). - Tray Jul 2017) period.
Harm - Lid
Note: Protective No harm to patient - Inner Pouch Product Condition
Packaging - Outer Pouch testing post 25 months
means the Impact - Product Box realtime aging (post
configuration of No health consequence/ - Protective Tube VAL08-0048) has been
materials Nuisance to patient or end user The materials, thickness and arrangement of completed for EVO-xx-
designed to design elements in layers provide sufficient yy-zz-D and EVO-xx-yy-
prevent 1 Likely III barriers to prevent puncturing of the Sterile Barrier 1 zz-C devices per ref: 1 III Yes No N/A
damage to the System. VAL08-0049 REPORT 2
sterile barrier Rev 0
system and its EVO-xx-yy-zz-D
contents until Design solutions employed using state of the art products are of similar
the point of approaches which address the cause of design to EVO-xx-yy-zz-
use. failure/failure mode. Such solutions relate to C product(s) tested
high degree of assurance of robust designs
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
Materials of Risk Control History shows 0 failure
protective The protective packaging consists of the following (s) out of 14724 devices
packaging not Design Elements that prevent objects ripping the used in patients over a 3
strong enough. Sterile Barrier System before use; year (03 Jul 2014 to 03
- Tray Jul 2017) period.
- Lid
- Inner Pouch Product Condition
- Outer Pouch testing post 25 months
- Product Box realtime aging (post
- Protective Tube VAL08-0048) has been
The materials, thickness and arrangement of completed for EVO-xx-
design elements in layers provide sufficient yy-zz-D and EVO-xx-yy-
barriers to prevent puncturing of the Sterile Barrier zz-C devices per ref:
System. VAL08-0049 REPORT 2
1 Rev 0 1 III Yes No N/A
EVO-xx-yy-zz-D
Design solutions employed using state of the art products are of similar
approaches which address the cause of design to EVO-xx-yy-zz-
failure/failure mode. Such solutions relate to C product(s) tested
Implementation
9. Packaging 9.1. Provide 9.1.1. Device is damaged before use. Situation Insufficient Risk Control History shows 0 failure
(Protective protection. Device cannot be used. protective The protective packaging consists of the following (s) out of 14724 devices
Packaging and packaging Design Elements that cushion the device from used in patients over a 3
Device). Harm surrounding the impacts and protect it during expected year (03 Jul 2014 to 03
No harm to patient device during transportation conditions; Jul 2017) period.
Note: Protective transportation. - Tray
Packaging Impact - Lid Transportation Testing
means the No health consequence/ - Inner Pouch has been completed for
configuration of Nuisance to patient or end user - Outer Pouch EVO-xx-yy-zz-D devices
materials - Product Box per ref: VAL07-0011
designed to - Shipper Carton. REPORT3 Rev 0
prevent - Protective Tube EVO-xx-yy-zz-C & EVO-
damage to the xx-yy-zz-D products are
sterile barrier 1 Likely III 1 of similar design to EVO- 1 III Yes No N/A
system and its Design solutions employed using state of the art xx-yy-zz-E product(s)
contents until approaches which address the cause of tested
the point of failure/failure mode. Such solutions relate to Transportation Testing
use. features/ geometry/ materials which provide a has been completed for
per ref: VAL07-0012
Implementation REPORT3 Rev 0
DWG0348 'Tray - Gastro SEMS TTS ' EVO-xx-yy-zz-C & EVO-
DWG0009 'Packaging Pouches' xx-yy-zz-D products are
CHT0037 'Specification for Packaging Boxes' of similar design to EVO-
RMS0044 'Rigid Protective Tubing' tested
Situation Insufficient Risk Control History shows 0 failure
Device used, malfunctioned protective The protective packaging consists of the following (s) out of 14724 devices
within patient packaging Design Elements that cushion the device from used in patients over a 3
surrounding the impacts and protect it during expected year (03 Jul 2014 to 03
Harm device during transportation conditions; Jul 2017) period.
Irritation / edema/ ulceration at 3 Likely IIB transportation. - Tray 1 1 IIA Yes No N/A
mucosa requiring medical - Lid Transportation Testing
intervention (such as - Inner Pouch has been completed for
medications) - Outer Pouch EVO-xx-yy-zz-D devices
- Product Box per ref: VAL07-0011
Impact - Shipper Carton. REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
Harm requiring medical - Protective Tube EVO-xx-yy-zz-C & EVO-
intervention, within the same xx-yy-zz-D products are
operating procedure. No further of similar design to EVO-
hospital stay required Design solutions employed using state of the art xx-yy-zz-E product(s)
approaches which address the cause of tested
per ref: VAL07-0012
Perforation (medical intervention transportation. - Tray
required) and/or major bleed - Lid Transportation Testing
(transfusion required) - Inner Pouch has been completed for
- Outer Pouch EVO-xx-yy-zz-D devices
Impact - Product Box per ref: VAL07-0011
Harm requiring secondary - Shipper Carton. REPORT3 Rev 0
intervention and/ or prolonged - Protective Tube EVO-xx-yy-zz-C & EVO-
hospitalisation required xx-yy-zz-D products are
4 Unlikely IIB 1 of similar design to EVO- 1 IIA Yes No N/A
Design solutions employed using state of the art xx-yy-zz-E product(s)
per ref: VAL07-0012
Perforation and/or minor bleed transportation. - Tray
(self-limited) - Lid Transportation Testing
- Inner Pouch has been completed for
Impact - Outer Pouch EVO-xx-yy-zz-D devices
Harm requiring medical - Product Box per ref: VAL07-0011
intervention, within the same - Shipper Carton. REPORT3 Rev 0
operating procedure. No further - Protective Tube EVO-xx-yy-zz-C & EVO-
hospital stay required xx-yy-zz-D products are
3 Likely IIB 1 of similar design to EVO- 1 IIA Yes No N/A
per ref: VAL07-0012
Device used, malfunctioned 3 Likely IIB protective The protective packaging consists of the following 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Foreign body / matter left in transportation. - Tray
patient which can be retrieved - Lid Transportation Testing
within the same procedure. - Inner Pouch has been completed for
- Outer Pouch EVO-xx-yy-zz-D devices
Impact - Product Box per ref: VAL07-0011
Harm requiring medical - Shipper Carton. REPORT3 Rev 0
intervention, within the same - Protective Tube EVO-xx-yy-zz-C & EVO-
operating procedure. No further xx-yy-zz-D products are
hospital stay required of similar design to EVO-
per ref: VAL07-0012
9.1.2. Protective packaging is damaged Situation Materials of Risk Control History shows 0 failure
before use. Device cannot be used. protective The protective packaging consists of the following (s) out of 14724 devices
Replacement device required packaging not Design Elements; used in patients over a 3
strong enough. - Tray year (03 Jul 2014 to 03
Harm - Lid Jul 2017) period.
No harm to patient - Inner Pouch
- Outer Pouch Product Condition
Impact - Product Box testing post 25 months
No health consequence/ -Protective Tube realtime aging (post
Nuisance to patient or end user - Shipper Carton VAL08-0048) has been
The materials and thickness of these design completed for EVO-xx-
elements provide sufficient strength to prevent yy-zz-D and EVO-xx-yy-
damage during expected transport conditions. zz-C devices per ref:
VAL08-0049 REPORT 2
1 Likely III 1 1 III Yes No N/A
Rev 0
Design solutions employed using state of the art EVO-xx-yy-zz-D
approaches which address the cause of products are of similar
failure/failure mode. Such solutions relate to design to EVO-xx-yy-zz-
features/ geometry/ materials which provide a C product(s) tested
Implementation
9.1.3. Particulate matter visible on Situation Gaps present in Risk Control History shows 0 failure
contents of protective packaging. Device cannot be used. protective The protective packaging is completely closed (s) out of 14724 devices
Replacement device required packaging. and prevents dirt from entering. used in patients over a 3
year (03 Jul 2014 to 03
No harm to patient Design solutions employed using state of the art
approaches which address the cause of Product Condition
Impact failure/failure mode. Such solutions relate to testing post 25 months
No health consequence/ features/ geometry/ materials which provide a realtime aging (post
Nuisance to patient or end user high degree of assurance of robust designs VAL08-0048) has been
1 Likely III established effective through clinical use. 1 completed for EVO-xx- 1 III Yes No N/A
DWG0348 'Tray - Gastro SEMS TTS ' VAL08-0049 REPORT 2
DWG0009 'Packaging Pouches' Rev 0
CHT0037 'Specification for Packaging Boxes' EVO-xx-yy-zz-D
DWG0481 'Tray - Gastro SEMS TTS Lid' products are of similar
RMS0044 'Rigid Protective Tubing' design to EVO-xx-yy-zz-
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
10. Packaging 10.1. Hold 10.1.1. Device is damaged before use. Situation Radius of curvature Risk Control History shows 0 failure
(Tray & product Device cannot be used. in holding track is The holding track in the tray is formed from (s) out of 14724 devices
contents). securely Replacement device required. too small. flexible plastic and has a radius which is used in patients over a 3
while compatible with the diameter of the outer sheath year (03 Jul 2014 to 03
providing Harm Risk mitigated by product Design features Jul 2017) period.
protectio No harm to patient
n. Design solutions employed using state of the art Simulated Use Testing
Impact approaches which address the cause of has been completed for
No health consequence/ failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
Nuisance to patient or end user features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
EVO-xx-yy-zz-D
DWG0497 'TTS SEMS Assembly' C product(s) tested
DWG1879 'Gastro SEMS outer sheath'
Impacts during Risk Control History shows 0 failure
transportation lead The Tray is designed with a lip on its outer (s) out of 14724 devices
to joint failures in perimeter that flexes when force is applied. This used in patients over a 3
device. cushions the product from impacts during year (03 Jul 2014 to 03
expected transportation conditions. The Lid is Jul 2017) period.
designed as to fully enclose the Handle
Assembly, protecting it from impacts during Transportation Testing
expected transportation conditions has been completed for
per ref: VAL07-0011
Design solutions employed using state of the art REPORT3 Rev 0
approaches which address the cause of EVO-xx-yy-zz-C & EVO-
failure/failure mode. Such solutions relate to xx-yy-zz-D products are
features/ geometry/ materials which provide a 1 of similar design to EVO- 1 III Yes No N/A
high degree of assurance of robust designs xx-yy-zz-E product(s)
established effective through clinical use. tested
Implementation has been completed for
DWG0348 'Tray - Gastro SEMS TTS ' EVO-xx-yy-zz-D and
1 Likely III DWG0481 'Tray - Gastro SEMS TTS Lid' EVO-xx-yy-zz-C devices
DWG0497 'TTS SEMS Assembly' per ref: VAL07-0012
REPORT3 Rev 0
tested
Tray flexes during Risk Control History shows 0 failure
transportation. The packaging design includes reinforcing boss. (s) out of 14724 devices
This Design Element adds rigidity to the Tray and used in patients over a 3
prevents it from flexing during expected year (03 Jul 2014 to 03
approaches which address the cause of EVO-xx-yy-zz-D devices
1 of similar design to EVO-
Implementation xx-yy-zz-E product(s) 1 III Yes No N/A
DWG0348 'Tray - Gastro SEMS TTS ' tested
CHT0037 'Specification for Packaging Boxes' Transportation Testing
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
Risk Control 1 History shows 0 failure
Min
Has risk
Probability Is a
of Risk ?
?
Control
The Tray includes snap points to hold the device (s) out of 14724 devices
in the Tray. used in patients over a 3
year (03 Jul 2014 to 03
Jul 2017) period.

Implementation
DWG1879 'Gastro SEMS outer sheath'
11. Packaging 11.1. Remain 11.1.1. Lid separates from Tray, Situation Insufficient Risk Control History shows 0 failure
(Lid, Tray and joined. releasing device before use. Device contaminated/damaged clearance in fit The Lid and Tray design includes locking features (s) out of 14724 devices
contents). and cannot be used. between Tray and that secure the design elements together with an used in patients over a 3
Replacement device required. Lid. interference fit. This feature keeps the Lid and year (03 Jul 2014 to 03
Tray joined together. Jul 2017) period.
Harm
No harm to patient Product Condition
Design solutions employed using state of the art testing post 25 months
Impact approaches which address the cause of realtime aging (post
No health consequence/ 1 Likely III failure/failure mode. Such solutions relate to 1 VAL08-0048) has been 1 III Yes No N/A
Nuisance to patient or end user features/ geometry/ materials which provide a completed for EVO-xx-
VAL08-0049 REPORT 2
DWG0348 'Tray - Gastro SEMS TTS ' EVO-xx-yy-zz-D
C product(s) tested
12. Packaging 12.1. Secure 12.1.1. Contents fall out of Product Box Situation Closure panels of Risk Control History shows 0 failure
(Product Box contents. before use. Device contaminated/damaged Product Box open The Product Box design includes a Tongue Lock (s) out of 14724 devices
and contents). and cannot be used. at a force equal to feature that prevents the closure panels from used in patients over a 3
Replacement device required. the weight of the opening. year (03 Jul 2014 to 03
contents. Jul 2017) period.
Harm
No harm to patient Design solutions employed using state of the art Product Condition
approaches which address the cause of testing post 25 months
Impact failure/failure mode. Such solutions relate to realtime aging (post
No health consequence/ features/ geometry/ materials which provide a VAL08-0048) has been
Nuisance to patient or end user high degree of assurance of robust designs completed for EVO-xx-
EVO-xx-yy-zz-D
C product(s) tested
1 Likely III 1 Transportation Testing 1 III Yes No N/A
per ref: VAL07-0011
REPORT3 Rev 0
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
12.2. Remain 12.2.1. Does not remain intact during Situation Incorrect Materials- Risk Control History shows 0 failure
intact transportation and storage Product box damaged Too weak (s) out of 14724 devices
during Aesthetics of product box The materials and thickness of these product box used in patients over a 3
transport compromised. provide sufficient strength to prevent damage year (03 Jul 2014 to 03
ation and Physician/Assistant uses device during expected transport conditions. Jul 2017) period.
storage
Harm Design solutions employed using state of the art Product Condition
No harm to patient approaches which address the cause of testing post 25 months
failure/failure mode. Such solutions relate to realtime aging (post
Impact features/ geometry/ materials which provide a VAL08-0048) has been
No health consequence/ high degree of assurance of robust designs completed for EVO-xx-
Nuisance to patient or end user established effective through clinical use. yy-zz-D and EVO-xx-yy-
EVO-xx-yy-zz-D
C product(s) tested
per ref: VAL07-0011
REPORT3 Rev 0
tested
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
Situation Incorrect Materials- Risk Control History shows 0 failure
Product box damaged. Device Too weak (s) out of 14724 devices
integrity compromised. The materials and thickness of these product box used in patients over a 3
Replacement device required provide sufficient strength to prevent damage year (03 Jul 2014 to 03
during expected transport conditions. Jul 2017) period.
Harm
No harm to patient Design solutions employed using state of the art Product Condition
approaches which address the cause of testing post 25 months
Impact failure/failure mode. Such solutions relate to realtime aging (post
No health consequence/ features/ geometry/ materials which provide a VAL08-0048) has been
Nuisance to patient or end user high degree of assurance of robust designs completed for EVO-xx-
1 Likely III 1 EVO-xx-yy-zz-D 1 III Yes No N/A
C product(s) tested
per ref: VAL07-0011
REPORT3 Rev 0
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
per ref: VAL07-0012
REPORT3 Rev 0
tested
13. Labelling 13.1. Maintain 13.1.1. Labelling crumpled and cannot Situation Label materials are Risk Control History shows 0 failure
(Label & IFU). integrity. be read. Label not present / legible, incompatible with Label & IFU materials are chosen to be (s) out of 14724 devices
instructions unclear. EtO Sterilisation compatible with EtO sterilisation. used in patients over a 3
Replacement device required. Risk mitigated by product materials (design for year (03 Jul 2014 to 03
product use). Jul 2017) period.
Harm
Impact failure/failure mode. Such solutions relate to 1 has been completed for 1 III Yes No N/A
No health consequence/ features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
Nuisance to patient or end user high degree of assurance of robust designs EVO-xx-yy-zz-C devices
Ver 0
C product(s) tested
Label material Risk Control History shows 0 failure
incompatible with Label materials and adhesive chosen to be (s) out of 14724 devices
protective compatible with the protective packaging. used in patients over a 3
packaging Risk mitigated by product materials (design for year (03 Jul 2014 to 03
product use) Jul 2017) period.

1 1 III Yes No N/A
Ver 0
1 Likely III CHT0037 'Specification for Packaging Boxes' products are of similar
RMS0207 'PRISYM LABELS RMN 90-307''
during Label & IFU materials chosen to be compatible (s) out of 14724 devices
transportation. with the conditions involved in transportation. used in patients over a 3
Risk mitigated by product materials (design for year (03 Jul 2014 to 03

failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
RMS0151 'IFU Specification Document' of similar design to EVO-
RMS0207 'PRISYM LABELS RMN 90-307'' xx-yy-zz-E product(s)
tested
over time. Label & IFU materials chosen to be stable over (s) out of 14724 devices
time. used in patients over a 3
year (03 Jul 2014 to 03
Risk mitigated by product materials (design for Jul 2017) period.
product use). 1 1 III Yes No N/A
Design solutions employed using state of the art post 25 months realtime
approaches which address the cause of aging (post VAL08-0048)
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT 2 Rev 0
Implementation 25 Months Realtime
RMS0151 'IFU Specification Document' Aging has been
RMS0207 'PRISYM LABELS RMN 90-307'' completed for EVO-xx-
VAL08-0048 REPORT 2
Rev 0
EVO-xx-yy-zz-D
C product(s) tested
13.2. Be 13.2.1. Text can be wiped off. Situation Ink material not Risk Control History shows 0 failure
legible. Label not legible, instructions compatible with The materials were chosen because they are (s) out of 14724 devices
unclear. substrate material. compatible. used in patients over a 3
Replacement device required Risk mitigated by product materials (design for year (03 Jul 2014 to 03
Harm
No harm to patient
Impact approaches which address the cause of
No health consequence/ failure/failure mode. Such solutions relate to
Nuisance to patient or end user features/ geometry/ materials which provide a
Implementation
RMS0151 'IFU Specification Document'
14. Labelling 14.1. Remain 14.1.1. Record Label detaches from Situation Label material Risk Control History shows 0 failure
(Record label). joined. Label before use. Label detaches, not retrievable incompatible with Label materials chosen to be compatible with EtO (s) out of 14724 devices
Replacement device required. EtO Sterilisation sterilisation. used in patients over a 3
process Risk mitigated by product materials (design for year (03 Jul 2014 to 03
Harm product use). Jul 2017) period.
No harm to patient
Impact approaches which address the cause of 1 1 III Yes No N/A
Implementation
Record Label and Risk Control History shows 0 failure
Label materials are The Record Label and Label materials are chosen (s) out of 14724 devices
incompatible. to be compatible with each other. used in patients over a 3
1 Likely III product use) Jul 2017) period.

approaches which address the cause of 1 1 III Yes No N/A
Implementation
degrades during Label material chosen to be compatible with the (s) out of 14724 devices
transportation. conditions involved in transportation. used in patients over a 3
product use). 1 Jul 2017) period. 1 III Yes No N/A

Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
degrades over Label material chosen to be stable over time. (s) out of 14724 devices
time. Risk mitigated by product materials (design for used in patients over a 3
product use). year (03 Jul 2014 to 03
Jul 2017) period.
1 1 III Yes No N/A
Implementation
14.2. Be 14.2.1. Record Label tears during Situation Tensile strength of Risk Control History shows 0 failure
removabl removal from Label. Label does not function correctly, Label facestock The Label facestock material is selected to (s) out of 14724 devices
e. detaches incorrectly. material too low. provide sufficient tensile strength during removal. used in patients over a 3
Risk mitigated by product materials. year (03 Jul 2014 to 03
No harm to patient
Impact approaches which address the cause of 1 1 III Yes No N/A
Implementation
Bond strength Risk Control History shows 0 failure
between Record The label stock design includes a backslit that (s) out of 14724 devices
Label and Label is ensures part of the non-stick backing of the label used in patients over a 3
too high. stock remains under the Record Labels. This year (03 Jul 2014 to 03
ensures the bond strength of the Record Label is Jul 2017) period.
low enough during removal.
Risk mitigated by product design features (design
for product use).
1 1 III Yes No N/A
1 Likely III approaches which address the cause of
Implementation
degrades during Label materials chosen to be compatible with EtO (s) out of 14724 devices
EtO Sterilisation sterilisation. used in patients over a 3

Implementation
degrades during Label material chosen to be compatible with the 1 (s) out of 14724 devices 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
transportation. conditions involved in transportation. used in patients over a 3

Implementation
degrades over Label stock material chosen to be stable over (s) out of 14724 devices
time. time. used in patients over a 3

1 1 III Yes No N/A
Implementation
15. Labelling. 15.1. Maintain 15.1.1. Patient Card damaged and Situation Materials degrade Risk Control History shows 0 failure
(Patient Card). integrity. cannot be read. Patient card does not function during sterilisation. Patient Card materials are chosen to be (s) out of 14724 devices
correctly, is damaged or not compatible with EtO sterilisation. used in patients over a 3
legible. Risk mitigated by product materials (design for year (03 Jul 2014 to 03
Replacement device required. product use). Jul 2017) period.
Harm
1 1 III Yes No N/A
Impact failure/failure mode. Such solutions relate to
No health consequence/ features/ geometry/ materials which provide a
Nuisance to patient or end user high degree of assurance of robust designs
Implementation
during Patient Card materials chosen to be compatible (s) out of 14724 devices
transportation. with the conditions involved in transportation. used in patients over a 3
1 Likely III product use). Jul 2017) period.
Design solutions employed using state of the art 1 1 III Yes No N/A
Implementation
over time. Patient Card materials chosen to be stable over (s) out of 14724 devices
time. used in patients over a 3
product use). 1 Jul 2017) period. 1 III Yes No N/A

Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
15.2. Be 15.2.1. Text can be wiped off. Situation Ink material not Risk Control History shows 0 failure
legible. Patient card is not legible. compatible with The materials were chosen because they are (s) out of 14724 devices
Replacement device required substrate material. compatible. used in patients over a 3
Harm product use). Jul 2017) period.
No harm to patient
Impact Design solutions employed using state of the art

No health consequence/ approaches which address the cause of
Nuisance to patient or end user failure/failure mode. Such solutions relate to
Implementation
15.3. Allow 15.3.1. Patient card cannot be written Situation Material of Patient Risk Control History shows 0 failure
writing. on. Patient Card cannot be used as Card not The material of the patient card is selected to (s) out of 14724 devices
intended. compatible with allow writing. used in patients over a 3
ink. Risk mitigated by product design features (design year (03 Jul 2014 to 03
Harm for product use). Jul 2017) period.
No harm to patient
Impact Design solutions employed using state of the art

No health consequence/ approaches which address the cause of
Nuisance to patient or end user failure/failure mode. Such solutions relate to
Implementation
16. User interface 16.1. Critical 16.1.1. Use error situation: Situation Size or style of Risk Control History shows 0 failure
(Potential task - Physician/Assistant fails to User cannot read label to identify font. The size and style of the font for the label are (s) out of 14724 devices
Causes of identify identify device because they device, replacement device chosen to be easily read. used in patients over a 3
Failure are device. cannot read the text of the label. required. year (03 Jul 2014 to 03
due to the Jul 2017) period.
user's Harm Design solutions employed using state of the art
interaction No harm to patient approaches which address the cause of
1 1 III Yes No N/A
with the failure/failure mode. Such solutions relate to
device) Impact features/ geometry/ materials which provide a
Implementation
Insufficient contrast Risk Control History shows 0 failure
between text and The best possible contrast was achieved because (s) out of 14724 devices
1 Likely III background. the background of the label is white and the text is used in patients over a 3
black. year (03 Jul 2014 to 03
Jul 2017) period.

Implementation
Glare on label from Risk Control History shows 0 failure
environmental The material of the label is such that 1 (s) out of 14724 devices 1 III Yes No N/A
lighting obscures environmental lighting does not obscure text due used in patients over a 3
Min
Has risk
Probability Is a
of Risk ?
?
Control
text. to glare. year (03 Jul 2014 to 03
Jul 2017) period.

Implementation
16.1.2. Use error situation: Situation Size or style of Risk Control History shows 0 failure
Physician/Assistant fails to Incorrect device is selected, font. The size and style of the font for the label are (s) out of 14724 devices
identify device because they inaccuracy is noted before point chosen to be easily read. used in patients over a 3
misread the label. of no return is reached. year (03 Jul 2014 to 03
Replacement device required. Design solutions employed using state of the art Jul 2017) period.
Harm failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Device replaced features/ geometry/ materials which provide a
without a health high degree of assurance of robust designs
consequence. established effective through clinical use.
Impact Implementation
No health consequence/ RMS0207 'PRISYM LABELS RMN 90-307''
Nuisance to patient or end user 1 Likely III Insufficient contrast Risk Control History shows 0 failure
background. the background of the label is white and the text is used in patients over a 3
Jul 2017) period.
1 1 III Yes No N/A
Implementation
Situation Size or style of Risk Control History shows 0 failure
Incorrect device is selected and font. The size and style of the font for the label are (s) out of 14724 devices
goes unnoticed. Stent deployed chosen to be easily read. used in patients over a 3
inaccurately. year (03 Jul 2014 to 03
Harm approaches which address the cause of
Continuation of occlusion (which failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
can be treated within the same features/ geometry/ materials which provide a
procedure) high degree of assurance of robust designs
Impact
Harm requiring medical Implementation
intervention, within the same RMS0207 'PRISYM LABELS RMN 90-307''
operating procedure. No further 3 Likely IIB
hospital stay required Insufficient contrast Risk Control History shows 0 failure
background. the background of the label is white and the text is used in patients over a 3
Jul 2017) period.
1 1 IIA Yes No N/A
Implementation
16.1.3. Use error situation: Situation No indication of Risk Control The effectiveness is
Physician/Assistant fails to Incorrect device selected, stent size on Label on handle provides information on stent inherent in the risk
correctly identify device Physician/Assistant notes 1 Likely III device size. This provides information to the 3 control 3 III Yes No N/A
inaccuracy prior to point of no Physician/Assistant on the stent size of the
return. Replacement device device.
Min
Has risk
Probability Is a
of Risk ?
?
Control
required. Device Information- Labelling/Instructions for Use
Harm operating principles, but cannot guarantee they
Device replaced will utilise the information
without a health
consequence.
Implementation
Impact RMS0046 'SEMS "Point of no return" Label'
No health consequence/
Nuisance to patient or end user
Situation No indication of Risk Control The effectiveness is
Physician/Assistant proceed with stent size on Label on handle provides information on stent inherent in the risk
Incorrect device and goes device size. This provides information to the control
unnoticed. Incorrect stent Physician/Assistant on the stent size of the
deployed device.
Harm (IFU) indicate to the user device usage details/
Continuation of occlusion (which operating principles, but cannot guarantee they
3 Likely IIB 3 3 IIB Yes No N/A
can be treated within the same will utilise the information
procedure)
Harm requiring medical RMS0046 'SEMS "Point of no return" Label'
hospital stay required
16.2. Critical 16.2.1. Use error situation: Situation Unable to grip and Risk Control History shows 0 failure
task - Physician/Assistant fails to Replacement device required. open packaging of The Tyvek layer includes a thumb notch feature. (s) out of 14724 devices
unpack unpack device because they Nuisance to the sterile barrier This feature allows the user to separate one used in patients over a 3
device. cannot open Sterile Barrier Physician/Assistant. system. material from the other and prepare to open the year (03 Jul 2014 to 03
System. Sterile Barrier System. Jul 2017) period.
Harm
No harm to patient
1 1 III Yes No N/A
Implementation
User applies Risk Control History shows 0 failure
insufficient force to The design of the Sterile Barrier System includes (s) out of 14724 devices
separate the a chevron-shaped seal in one side of package. used in patients over a 3
materials of the This concentrates the force applied by the year (03 Jul 2014 to 03
Sterile Barrier Physician/Assistant to one point on the seal such Jul 2017) period.
System. (Using that it can be easily opened.
1 Likely III chevron-shaped
seal side)
Design solutions employed using state of the art 1 1 III Yes No N/A
Implementation
User applies Risk Control History shows 0 failure
insufficient force to The design of the Sterile Barrier pouch System (s) out of 14724 devices
separate the has appropriate seal to be easily opened at a low used in patients over a 3
materials of the force. year (03 Jul 2014 to 03
Sterile Barrier Jul 2017) period.
System. (using Design solutions employed using state of the art
side without approaches which address the cause of 1 1 III Yes No N/A
chevron-shaped failure/failure mode. Such solutions relate to
seal) features/ geometry/ materials which provide a
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
16.2.2. Use error situation: Situation Risk Control History shows 0 failure
Physician/Assistant fails to Replacement device required. Physician/Assistant The design of the Sterile Barrier pouch System (s) out of 14724 devices
correctly unpack device - Nuisance to the has to apply has appropriate seal to be easily opened. used in patients over a 3
They open the Sterile Barrier Physician/Assistant. excessive force to year (03 Jul 2014 to 03
System but the device falls onto open the Sterile Design solutions employed using state of the art Jul 2017) period.
the floor. Harm Barrier System and approaches which address the cause of
No harm to patient 1 Likely III cannot control it failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
when it does opens features/ geometry/ materials which provide a
Impact suddenly. high degree of assurance of robust designs
No health consequence/ established effective through clinical use.
Implementation
16.2.3. Use error situation: Situation Angle that Risk Control History shows 0 failure
Physician/Assistant fails to Replacement device required. Physician/Assistant The device tray is designed to enable ease of (s) out of 14724 devices
correctly unpack device Nuisance to the bends device removal of the device used in patients over a 3
because they kink the device Physician/Assistant. during removal year (03 Jul 2014 to 03
whilst removing it from tray. from tray is too Jul 2017) period.
Harm acute. Design solutions employed using state of the art
No harm to patient approaches which address the cause of
Impact 1 Likely III features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
No health consequence/ high degree of assurance of robust designs EVO-xx-yy-zz-D and
Nuisance to patient or end user established effective through clinical use. EVO-xx-yy-zz-C devices
DWG0348 'Tray - Gastro SEMS TTS ' EVO-xx-yy-zz-D
C product(s) tested
16.3. Critical 16.3.1. Use error situation: Situation Risk Control History shows 0 failure
task - Physician/Assistant does not Physician/Assistant unaware as Physician/Assistant IFU pouch is made of transparent material. (s) out of 14724 devices
read and read/follow instructions to the correct use of the device. cannot locate the used in patients over a 3
follow Replacement device required. IFU because it is year (03 Jul 2014 to 03
instructio obscured by Design solutions employed using state of the art Jul 2017) period.
ns. Harm packaging and not approaches which address the cause of
No harm to patient 1 Likely III readily visible failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Implementation
RMS0151 'IFU Specification Document'
16.3.2. Use error situation: Situation Size or style of Risk Control History shows 0 failure
Physician/Assistant can not Incorrect device selected, font. The size and style of the font for the IFU are (s) out of 14724 devices
read instructions Physician/Assistant selects a chosen to be easily read. used in patients over a 3
legible replacement device. year (03 Jul 2014 to 03
Jul 2017) period.
failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Implementation
1 Likely III IFU0053- Evolution™ Duodenal Stent System
Insufficient Risk Control History shows 0 failure
contrast between The best possible contrast was achieved because (s) out of 14724 devices
text and the background of the IFU is white and the text is used in patients over a 3
background. black. year (03 Jul 2014 to 03
Jul 2017) period.
1 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
16.3.3. Use error situation: Situation Physician is Risk Control The effectiveness is
Physician/Assistant uses device Physician/Assistant does not unaware of device Device intended use specified in the IFU inherent in the risk
in a situation other than follow IFU steps for the correct use restrictions Device Information- Labelling/Instructions for Use control
specified witin the Instructions use of the device. Device is used (IFU) indicate to the user device usage details/
for Use. in a potentially harmful manner. operating principles, but cannot guarantee they
Harm
Perforation and/or minor bleed 3 Likely IIB Implementation 3 3 IIB Yes No N/A
(self-limited) IFU0053- Evolution™ Duodenal Stent System
Impact
Harm requiring medical
Situation Physician is Risk Control The effectiveness is
Physician/Assistant does not unaware of device Device intended use specified in the IFU inherent in the risk
follow IFU steps for the correct use restrictions Device Information- Labelling/Instructions for Use control
use of the device. Device is used (IFU) indicate to the user device usage details/
in a potentially harmful manner. operating principles, but cannot guarantee they
Harm
Perforation (medical intervention 4 Unlikely IIB Implementation 3 3 IIB Yes No N/A
required) and/or major bleed IFU0053- Evolution™ Duodenal Stent System
(transfusion required) IFU0052- Evolution™ Colonic Stent System
Impact
Harm requiring secondary
intervention and/ or prolonged
hospitalisation required
Situation Physician is Risk Control The effectiveness is
Physician/Assistant unaware as unaware of device Device intended use specified in the IFU inherent in the risk
to the correct use of the device. use restrictions Device Information- Labelling/Instructions for Use control
Device is used in a potentially (IFU) indicate to the user device usage details/
harmful manner. operating principles, but cannot guarantee they
Harm
No harm to patient Implementation
Impact IFU0052- Evolution™ Colonic Stent System
16.4. Complet 16.4.1. Physician/Assistant error Situation Physician/Assistant Risk Control The effectiveness is
e situation: Physician/Assistant selects is unaware of the IFU contains instruction to perform full diagnostic inherent in the risk
diagnosti Does not do diagnostic length of stent incorrectly. requirement for evaluation to determine required stent size. control
c Evaluation Majority of stent is in contact with diagnostic Device Information- Labelling/Instructions for Use
evaluatio healthy tissue. evaluation (IFU) indicate to the user device usage details/
n. operating principles, but cannot guarantee they
Harm 2 Likely IIA will utilise the information 3 3 IIA Yes No N/A
Irritation / edema/ ulceration/
erosion at mucosa Implementation
Situation Physician/Assistant Risk Control The effectiveness is
Physician/Assistant selects is unaware of the IFU contains instruction to perform full diagnostic inherent in the risk
length of stent incorrectly. Stent requirement for evaluation to determine required stent size. control
is shorter than lesion. Lesion diagnostic Device Information- Labelling/Instructions for Use
goes untreated. evaluation (IFU) indicate to the user device usage details/
3 Likely IIB operating principles, but cannot guarantee they 3 3 IIB Yes No N/A
Harm will utilise the information
Continuation of occlusion (which
can be treated within the same Implementation
procedure) IFU0053- Evolution™ Duodenal Stent System
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact
Physician/Assistant selects is unaware of the IFU contains instruction to perform full diagnostic inherent in the risk
length of stent incorrectly. Stent requirement for evaluation to determine required stent size. control
is shorter than lesion. Lesion diagnostic Device Information- Labelling/Instructions for Use
goes untreated. evaluation (IFU) indicate to the user device usage details/
4 Unlikely IIB 3 3 IIB Yes No N/A
Reocclusion occurs, requiring
secondary intervention Implementation
16.5. Critical 16.5.1. Physician/Assistant fails to Situation Incorrect Risk Control History shows 0 failure
task - select appropriate wire guide. Device gets stuck on wireguide dimensions: The ID of the FLLA Socket, Adapter Female Leur (s) out of 14724 devices
Select during deployment, Wireguide Dimensions of Lock, PEEK Tubing + Introducer Tip, as specified used in patients over a 3
appropri and device must be removed. Introducer are by design, are compatible with the OD of the year (03 Jul 2014 to 03
ate wire Replacement wireguide and incompatible with recommended wireguide Jul 2017) period.
guide device required. Prolonged dimensions of
procedure. reccommended Design solutions employed using state of the art
wireguide approaches which address the cause of
Harm failure/failure mode. Such solutions relate to
Device replaced features/ geometry/ materials which provide a
without a health high degree of assurance of robust designs
consequence. established effective through clinical use.
No health consequence/ IFU0053- Evolution™ Duodenal Stent System
Nuisance to patient or end user IFU0052- Evolution™ Colonic Stent System
DWG0319 'FLLA Socket'
RMS0005 'Tubing : Peek'
DWG0302 'TTS Introducer Tip'
DWG0341 'Evolution Duodenal/Colonic
Introducer'
15527 'Adapter Female LeurLock'
Situation Incorrect Risk Control History shows 0 failure
Device prolapses wireguide and dimensions: The ID of the FLLA Socket, Adapter Female Leur (s) out of 14724 devices
cannot be advanced. Dimensions of Lock, PEEK Tubing + Introducer Tip, as specified used in patients over a 3
Replacement wireguide required. Introducer are by design, are compatible with the OD of the year (03 Jul 2014 to 03
Prolonged procedure. incompatible with recommended wireguide Jul 2017) period.
dimensions of
Harm reccommended Design solutions employed using state of the art
Insignificant delay in procedure. wireguide approaches which address the cause of
Implementation
Introducer'
Wireguide does not provide dimensions: The ID of the FLLA Socket, Adapter Female Leur (s) out of 14724 devices
sufficient support and kinks Dimensions of Lock, PEEK Tubing + Introducer Tip, as specified used in patients over a 3
during deployment. Device will Introducer are by design, are compatible with the OD of the year (03 Jul 2014 to 03
not deploy stent. Replacement 1 Likely III incompatible with recommended wireguide 1 Jul 2017) period. 1 III Yes No N/A
wireguide required. Prolonged dimensions of
procedure. reccommended Design solutions employed using state of the art
wireguide approaches which address the cause of
Min
Has risk
Probability Is a
of Risk ?
?
Control
Insignificant delay in procedure. features/ geometry/ materials which provide a
Nuisance to patient or end user Implementation
Introducer'
16.6. Critical 16.6.1. Physician/Assistant does not Situation Physician/Assistant Risk Control The effectiveness is
task - introduce wireguide through Wire guide is not located into unaware that Instructions for use includes step to place wire inherent in the risk
Introduce stricture correct location, Introduction wireguide has to be guide through stricture. control
wire system cannot be guided inserted though Device Information- Labelling/Instructions for Use
guide correctly across the stricture. stricture (IFU) indicate to the user device usage details/
through operating principles, but cannot guarantee they
stricture Harm 2 Likely IIA will utilise the information 3 3 IIA Yes No N/A
Additional exposure to sedation,
radiation and/or contrast Implementation
Wire guide is not located into unaware that Instructions for use includes step to place wire inherent in the risk
correct location, Introduction wireguide has to be guide through stricture. control
system cannot be guided inserted though Device Information- Labelling/Instructions for Use
correctly across the stricture. stricture (IFU) indicate to the user device usage details/
Perforation and/or minor bleed 3 Likely IIB 3 3 IIB Yes No N/A
(self-limited) Implementation
16.6.2. Physician/Assistant uses Situation Physician/Assistant Risk Control The effectiveness is
incorrectly sized wire guide. Wire guide does not provide knows a wire guide Instructions for use includes appropriate wire- inherent in the risk
sufficient support to device, is required but guide size. control
diameter too small. Device will does not
not reach target site. understand a Device Information- Labelling/Instructions for Use
Replacement wire guide required. specific size is (IFU) indicate to the user device usage details/
required for this operating principles, but cannot guarantee they
Harm device and will utilise the information
Additional exposure to sedation, inappropriate
radiation and/or contrast diameter wire guide Implementation
is used. IFU0053- Evolution™ Duodenal Stent System
Situation Physician/Assistant Risk Control None.
Wire guide is too short and selects a wire There is no Risk control
device cannot reach target site. guide which is too
Replacement wire guide required. short.
Harm
radiation and/or contrast
Impact
Wire guide is too large and 1 Likely III knows a wire guide Instructions for use includes appropriate wire- 3 inherent in the risk 3 III Yes No N/A
cannot fit in device. Replacement is required but guide size. control
Min
Has risk
Probability Is a
of Risk ?
?
Control
wire guide required. does not
understand a Device Information- Labelling/Instructions for Use
Harm specific size is (IFU) indicate to the user device usage details/
No harm to patient required for this operating principles, but cannot guarantee they
device and will utilise the information
Impact inappropriate
No health consequence/ diameter wire guide Implementation
Nuisance to patient or end user is used. IFU0053- Evolution™ Duodenal Stent System
16.7. Critical 16.7.1. Physician/Assistant selects Situation Physician/assistant Risk Control The effectiveness is
task - Incorrect stent size Majority of stent is in contact with unaware of the IFU precautions specify the requirement for full inherent in the risk
Select healthy tissue. requirement to diagnostic evaluation to determine proper stent control
correct accurately size.
stent Harm measure the lesion Device Information- Labelling/Instructions for Use
size No harm to patient (IFU) indicate to the user device usage details/
Impact will utilise the information
Nuisance to patient or end user Implementation
Situation Physician/assistant Risk Control The effectiveness is
Stent is shorter than lesion. unaware of the IFU precautions specify the requirement for full inherent in the risk
Lesion goes untreated. requirement to diagnostic evaluation to determine proper stent control
accurately size.
Harm measure the lesion Device Information- Labelling/Instructions for Use
Continuation of occlusion (which (IFU) indicate to the user device usage details/
can be treated within the same operating principles, but cannot guarantee they
procedure) will utilise the information
Harm requiring medical IFU0053- Evolution™ Duodenal Stent System
intervention, within the same IFU0052- Evolution™ Colonic Stent System
Stent size chosen is too long and unaware of the IFU precautions specify the requirement for full inherent in the risk
protrudes excessively into requirement to diagnostic evaluation to determine proper stent control
patient's stomach accurately size.
measure the lesion Device Information- Labelling/Instructions for Use
Irritation / edema/ ulceration at operating principles, but cannot guarantee they
mucosa requiring medical will utilise the information
intervention (such as
medications) Implementation
patient's stomach. Stent migrates accurately size.
measure the lesion Device Information- Labelling/Instructions for Use
Foreign body / matter left in operating principles, but cannot guarantee they
patient which requires secondary will utilise the information
intervention.
Implementation
Impact IFU0053- Evolution™ Duodenal Stent System
Harm requiring secondary IFU0052- Evolution™ Colonic Stent System
patient's stomach. Stent 4 Unlikely IIB accurately size. 3 3 IIB Yes No N/A
fractures. measure the lesion Device Information- Labelling/Instructions for Use
Min
Has risk
Probability Is a
of Risk ?
?
Control
Foreign body / matter left in will utilise the information
patient which requires secondary
intervention. Implementation
Stent size chosen does not allow unaware of the IFU precautions specify the requirement for full inherent in the risk
for curvature inside requirement to diagnostic evaluation to determine proper stent control
duodenum/colon. Stent does not accurately size.
adequately bridge stricture measure the lesion Device Information- Labelling/Instructions for Use
Continuation of occlusion (which will utilise the information
can be treated within the same
procedure) Implementation
Stent size chosen does not allow unaware of the IFU precautions specify the requirement for full inherent in the risk
for curvature inside requirement to diagnostic evaluation to determine proper stent control
duodenum/colon. Stent places accurately size.
sharp pressure on lumen measure the lesion Device Information- Labelling/Instructions for Use
Irritation / edema/ ulceration at will utilise the information
mucosa requiring medical 3 Likely IIB 3 3 IIB Yes No N/A
intervention (such as Implementation
medications) IFU0053- Evolution™ Duodenal Stent System
Impact
16.8. Critical 16.8.1. Physician/Assistant fails to Situation Physician/assistant Risk Control The effectiveness is
Task - check packaging for damage Device has kinks, bends or unaware of the IFU notes specify the requirement for inspection inherent in the risk
Check breaks. Replacement device requirement to of packaging prior to use. control
packagin required. check packaging Device Information- Labelling/Instructions for Use
g for for damage before (IFU) indicate to the user device usage details/
device Harm 1 Likely III use operating principles, but cannot guarantee they 3 3 III Yes No N/A
damage No harm to patient will utilise the information
16.9. Critical 16.9.1. Physician/Assistant damages Situation Assistant unable to Risk Control History shows 0 failure
task - device during opening Device is damaged. Damage is grip package to Box design includes a finger grip on a locking (s) out of 14724 devices
Open noticed. Replacement device open box. feature that allows the user to open and access used in patients over a 3
device required. the opening flap of the box. year (03 Jul 2014 to 03
packagin Jul 2017) period.
g Harm Design solutions employed using state of the art
1 1 III Yes No N/A
No health consequence/ 1 Likely III high degree of assurance of robust designs
Implementation
Inability to separate Risk Control History shows 0 failure
the materials of the The design of the Sterile Barrier System includes (s) out of 14724 devices
Sterile Barrier a notch feature where one material does not 1 used in patients over a 3 1 III Yes No N/A
System to prepare overlap the other. This feature allows the user to year (03 Jul 2014 to 03
Min
Has risk
Probability Is a
of Risk ?
?
Control
to open. separate one material from the other and prepare Jul 2017) period.
to open the Sterile Barrier System.

Implementation
Force that Risk Control History shows 0 failure
Physician/Assistant The design of the Sterile Barrier System includes (s) out of 14724 devices
can apply is too low a chevron-shaped seal. This concentrates the used in patients over a 3
to separate the force applied by the assistant to one point on the year (03 Jul 2014 to 03
materials of the seal such that it opens at a low force. Jul 2017) period.
Sterile Barrier
System. Design solutions employed using state of the art
Implementation
Situation Assistant unable to Risk Control History shows 0 failure
Use error situation: grip package to Box design includes a finger grip on a locking (s) out of 14724 devices
Physician/Assistant open box. feature that allows the user to open and access used in patients over a 3
kinks/damages the device the opening flap of the box. year (03 Jul 2014 to 03
removing it from tray. Difficulty in Jul 2017) period.
deployment or recapture. Design solutions employed using state of the art
Replacement device is required. approaches which address the cause of
1 1 IIA Yes No N/A
Harm features/ geometry/ materials which provide a
Additional exposure to sedation, high degree of assurance of robust designs
radiation and/or contrast established effective through clinical use.
Temporary discomfort- medical CHT0037 'Specification for Packaging Boxes'
Sterile Barrier a notch feature where one material does not used in patients over a 3

Implementation
Sterile Barrier
approaches which address the cause of 1 1 IIA Yes No N/A
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
removing it from tray. Difficulty in Jul 2017) period.
deployment. Physician/Assistant Design solutions employed using state of the art
completes procedure. approaches which address the cause of
1 1 IIA Yes No N/A
Harm features/ geometry/ materials which provide a
Additional exposure to sedation, high degree of assurance of robust designs
radiation and/or contrast established effective through clinical use.
Temporary discomfort- medical CHT0037 'Specification for Packaging Boxes'

1 1 IIA Yes No N/A
2 Likely IIA approaches which address the cause of
Implementation
Sterile Barrier
Implementation
removing it from tray. Piece Jul 2017) period.
separates from device and Design solutions employed using state of the art
Physician/Assistant completes approaches which address the cause of
1 1 IIA Yes No N/A
procedure. failure/failure mode. Such solutions relate to
Harm high degree of assurance of robust designs
Additional exposure to sedation, established effective through clinical use.
2 Likely IIA Implementation
Impact CHT0037 'Specification for Packaging Boxes'
intervention not required Inability to separate Risk Control History shows 0 failure
to open the Sterile Barrier System. 1 1 IIA Yes No N/A

Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Sterile Barrier
Implementation
removing it from tray. Piece Jul 2017) period.
separates from device and Design solutions employed using state of the art
Physician/Assistant continue with approaches which address the cause of
1 1 IIA Yes No N/A
procedure. failure/failure mode. Such solutions relate to
Foreign body / matter left in established effective through clinical use.
patient which can be retrieved
within the same procedure. Implementation
Impact
Harm requiring medical Inability to separate Risk Control History shows 0 failure
intervention, within the same the materials of the The design of the Sterile Barrier System includes (s) out of 14724 devices
operating procedure. No further Sterile Barrier a notch feature where one material does not used in patients over a 3
hospital stay required System to prepare overlap the other. This feature allows the user to year (03 Jul 2014 to 03

1 1 IIA Yes No N/A
3 Likely IIB approaches which address the cause of
Implementation
Sterile Barrier
Implementation
16.9.2. Physician/Assistant Situation Assistant has to Risk Control History shows 0 failure
contaminates device during Physician/Assistant error apply excessive The design of the Sterile Barrier System includes (s) out of 14724 devices
opening situation: Device is contaminated. force to open the a chevron-shaped seal. This concentrates the used in patients over a 3
Replacement device required. 1 Likely III Sterile Barrier force applied by the assistant to one point on the 1 year (03 Jul 2014 to 03 1 III Yes No N/A
System and cannot seal such that it opens at a low force. Jul 2017) period.
Harm control it when it
Min
Has risk
Probability Is a
of Risk ?
?
Control
No harm to patient or end user opens suddenly Design solutions employed using state of the art
and grabs device approaches which address the cause of
Impact before it falls. failure/failure mode. Such solutions relate to
Implementation
16.10. Critical 16.10.1. Physician/Assistant does Situation Physician/Assistant Risk Control The effectiveness is
task - not/cannot remove protective Device cannot be inserted into unaware that The labelling includes a diagram showing that a inherent in the risk
Remov tubing from device patient. Physician/Assistant protective tubing minimum 3.7mm endoscopic working channel control
e removes device, replacement has to be removed. should be used. Hence, it would be impossible to
device device required. continue the procedure without removing the
from protective tubing as it could not pass through the
protecti Harm endoscope.
ve No harm to patient Potential Cause of failure eliminated
packagi
ng Impact Implementation
No health consequence/ RMS0207 'PRISYM LABELS RMN 90-307''
Use error situation: unaware that The labelling includes a diagram showing that a inherent in the risk
Physician/Assistant protective tubing minimum 3.7mm endoscopic working channel control
kinks/damage device used has to be removed. should be used. Hence, it would be impossible to
removing it from tray. Cannot continue the procedure without removing the
deploy stent. Replacement protective tubing as it could not pass through the
device required. endoscope.
2 Likely IIA Potential Cause of failure eliminated 3 3 IIA Yes No N/A
Harm
Additional exposure to sedation, Implementation
radiation and/or contrast RMS0207 'PRISYM LABELS RMN 90-307''
Impact
16.10.2. Physician/Assistant damages Situation Angle that Risk Control the efffectiveness is
device during removal of Device is damaged. Damage is Physician/Assistant The design of the tray mitigates against the inherent in the risk
protective tube noticed. Replacement device bends device Physician/Assistant to use excess force upon control
required. during removal removal thus bending the product at an acute
from tray is too angle
Harm 1 Likely III acute. Potential Cause of failure addressed 1 1 III Yes No N/A
No harm to patient
Implementation
Impact DWG0497 'TTS SEMS Assembly'
No health consequence/ RMS0044 'Rigid Protective Tubing'
Situation Angle that Risk Control the efffectiveness is
Use error situation: Physician/Assistant The design of the tray mitigates against the inherent in the risk
Physician/Assistant bends device Physician/Assistant to use excess force upon control
kinks/damage device used during removal removal thus bending the product at an acute
removing it from protective tube. from tray is too angle
Difficulty in deployment or acute. Potential Cause of failure addressed
recapturing. Replacement of
device is required. Implementation
Harm RMS0044 'Rigid Protective Tubing'
Impact
16.11. Critical 16.11.1. User Error: Does not introduce Situation Physician/Assistant Risk Control The effectiveness is
task - over the wire guide Physician/Assistant kinks device unaware that Instructions for use includes a step that describes inherent in the risk
Introduc during deployment. Procedure introduction system to introduce and advance system over wire guide control
e cannot continue. Replacement has to be
delivery device required. Wire guide to be 2 Likely IIA introduced over Device Information- Labelling/Instructions for Use 3 3 IIA Yes No N/A
system introduced. wire guide. (IFU) indicate to the user device usage details/
into operating principles, but cannot guarantee they
endosc Harm will utilise the information
Min
Has risk
Probability Is a
of Risk ?
?
Control
opy Additional exposure to sedation,
channel radiation and/or contrast Implementation
over IFU0053- Evolution™ Duodenal Stent System
wire Impact IFU0052- Evolution™ Colonic Stent System
guide in Temporary discomfort- medical
short intervention not required
increme
nts. 16.11.2. Physician/Assistant uses Situation Physician/assistant Risk Control The effectiveness is
excess force during Delivery system does not reach does not advance Instructions for use includes a step that describes inherent in the risk
deployment of device on wire target site. device smoothly to introduce and advance system over wire guide control
guide over wire guide. in short increments.
Harm
Minor trauma to mucosa Device Information- Labelling/Instructions for Use
2 Likely IIA (IFU) indicate to the user device usage details/ 3 3 IIA Yes No N/A
Impact operating principles, but cannot guarantee they
Temporary discomfort- medical will utilise the information
Implementation
User damages stricture wall does not advance Instructions for use includes a step that describes inherent in the risk
causing discomfort to patient. device smoothly to introduce and advance system over wire guide control
over wire guide. in short increments.
Harm
Irritation / edema/ ulceration/ Device Information- Labelling/Instructions for Use
erosion at mucosa 2 Likely IIA (IFU) indicate to the user device usage details/ 3 3 IIA Yes No N/A
causing perforation. device smoothly to introduce and advance system over wire guide control
over wire guide. in short increments.
Harm
Perforation and/or minor bleed Device Information- Labelling/Instructions for Use
(self-limited) 3 Likely IIB (IFU) indicate to the user device usage details/ 3 3 IIB Yes No N/A
intervention, within the same Implementation
operating procedure. No further IFU0053- Evolution™ Duodenal Stent System
hospital stay required IFU0052- Evolution™ Colonic Stent System
causing duodenum or colon device smoothly to introduce and advance system over wire guide control
rupture. over wire guide. in short increments.
Harm Device Information- Labelling/Instructions for Use

Perforation (medical intervention (IFU) indicate to the user device usage details/
required) and/or major bleed operating principles, but cannot guarantee they
(transfusion required) will utilise the information
Harm requiring secondary IFU0053- Evolution™ Duodenal Stent System
intervention and/ or prolonged IFU0052- Evolution™ Colonic Stent System
User moves position of wireguide does not advance Instructions for use includes a step that describes inherent in the risk
away from stricture. Wire guide device smoothly to introduce and advance system over wire guide control
must be repositioned. Prolonged over wire guide. in short increments.
procedure.
Harm 2 Likely IIA (IFU) indicate to the user device usage details/ 3 3 IIA Yes No N/A
Additional exposure to sedation, operating principles, but cannot guarantee they
radiation and/or contrast will utilise the information
Temporary discomfort- medical IFU0053- Evolution™ Duodenal Stent System
Min
Has risk
Probability Is a
of Risk ?
?
Control
intervention not required IFU0052- Evolution™ Colonic Stent System
16.11.3. User Error: Physician/ Situation Physician/Assistant Risk Control The effectiveness is
Assistant uses incorrect size of Physician/Assistant passes unaware of the The Labelling on the Outer Pouch specifies the inherent in the risk
endoscope device through endoscope with minimum required endoscope working channel to complete control
difficulty and continues endoscopic the procedure
procedure. channel size Labelling/Instructions for use (IFU)- Device
requirement information in the form of warnings/potential
3 3 III Yes No N/A
Harm complications where the controls do not constitute
No harm to patient risk reduction activities, and therefore equate to
no risk controls in place
Impact
No health consequence/ Implementation
Nuisance to patient or end user 1 Likely III RMS0207 'PRISYM LABELS RMN 90-307''
Physician/Assistant Risk Control The effectiveness is
applies excessive The IFU specifies that the user 'Introduce in short inherent in the risk
force on the increments' through the endoscope. control
introducer whilst Device Information- Labelling/Instructions for Use
trying to (IFU) indicate to the user device usage details/
manipulate it operating principles, but cannot guarantee they 3 3 III Yes No N/A
through the will utilise the information
endoscope working
channel. Implementation
Device cannot be used in patient. unaware of the The Labelling on the Outer Pouch specifies the inherent in the risk
Physician/Assistant removes minimum required endoscope working channel to complete control
device from endoscope. endoscopic the procedure
Replacement device required. channel size Labelling/Instructions for use (IFU)- Device
requirement information in the form of warnings/potential
3 3 III Yes No N/A
Harm complications where the controls do not constitute
Device replaced risk reduction activities, and therefore equate to
without a health no risk controls in place
consequence.
Implementation
Impact 1 Likely III RMS0207 'PRISYM LABELS RMN 90-307''
Nuisance to patient or end user Physician/Assistant Risk Control The effectiveness is
manipulate it operating principles, but cannot guarantee they 3 3 III Yes No N/A
endoscope working
Device becomes stuck in unaware of the The Labelling on the Outer Pouch specifies the inherent in the risk
endoscope. Physician/Assistant minimum required endoscope working channel to complete control
removes endoscope and device endoscopic the procedure
from patient. Continues channel size Labelling/Instructions for use (IFU)- Device
procedure with both replacement requirement information in the form of warnings/potential
3 3 IIA Yes No N/A
device and endoscope complications where the controls do not constitute
risk reduction activities, and therefore equate to
Harm no risk controls in place
radiation and/or contrast Implementation
Impact 2 Likely IIA
Temporary discomfort- medical Physician/Assistant Risk Control The effectiveness is
intervention not required applies excessive The IFU specifies that the user 'Introduce in short inherent in the risk
manipulate it operating principles, but cannot guarantee they 3 3 IIA Yes No N/A
endoscope working
Min
Has risk
Probability Is a
of Risk ?
?
Control
Device becomes damaged in unaware of the The Labelling on the Outer Pouch specifies the inherent in the risk
endoscope. Device malfunctions minimum required endoscope working channel to complete control
in patient. endoscopic the procedure
channel size Labelling/Instructions for use (IFU)- Device
Harm requirement information in the form of warnings/potential
3 3 IIB Yes No N/A
Continuation of occlusion (which complications where the controls do not constitute
can be treated within the same risk reduction activities, and therefore equate to
procedure) no risk controls in place
Harm requiring medical 3 Likely IIB RMS0207 'PRISYM LABELS RMN 90-307''
operating procedure. No further Physician/Assistant Risk Control The effectiveness is
hospital stay required applies excessive The IFU specifies that the user 'Introduce in short inherent in the risk
manipulate it operating principles, but cannot guarantee they 3 3 IIB Yes No N/A
endoscope working
Device becomes damaged in unaware of the The Labelling on the Outer Pouch specifies the inherent in the risk
endoscope. Device malfunctions minimum required endoscope working channel to complete control
in patient. endoscopic the procedure
channel size Labelling/Instructions for use (IFU)- Device
Harm requirement information in the form of warnings/potential
3 3 IIB Yes No N/A
Perforation and/or minor bleed complications where the controls do not constitute
(self-limited) risk reduction activities, and therefore equate to
no risk controls in place
Impact
intervention, within the same 3 Likely IIB RMS0207 'PRISYM LABELS RMN 90-307''
hospital stay required Physician/Assistant Risk Control The effectiveness is
manipulate it operating principles, but cannot guarantee they 3 3 IIB Yes No N/A
endoscope working
16.11.4. Physician/Assistant uses Situation There is no Risk Control None. The
incorrect type of endoscope Physician/Assistant passes reference to using There is no risk control severity
device through incorrect type of a particular type of associat
endoscope without difficulty endoscope in the Implementation ed with
IFU or Labelling None. this risk
Harm is such
No harm to patient that
there is
Impact no
No health consequence/ potential
Nuisance to patient or end user for harm
to the
1 Likely III 5 5 III patient / No N/A
end-
user.
Further
risk
reductio
n
activitie
s will
not have
any
clinical
impact.
Min
Has risk
Probability Is a
of Risk ?
?
Control
Situation There is no Risk Control None. History
Physician/Assistant passes reference to using There is no risk control shows 0
device through incorrect type of a particular type of failure
endoscope with difficulty and endoscope in the Implementation (s) out
continues procedure. IFU or Labelling None. of
14724
Harm devices
Minor trauma to mucosa used in
patients
Impact over a 3
Temporary discomfort- medical year (03
intervention not required Jul 2014
to 03 Jul
2017)
2 Likely IIA 5 5 IIA period. No N/A
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
Device becomes stuck in wrong reference to using There is no risk control shows 0
type of endoscope. a particular type of failure
Physician/Assistant removes endoscope in the Implementation (s) out
endoscope and device from IFU or Labelling None. of
patient. Continues procedure with 14724
both replacement device and devices
endoscope used in
patients
Harm over a 3
Additional exposure to sedation, year (03
radiation and/or contrast Jul 2014
to 03 Jul
Impact 2017)
Temporary discomfort- medical 2 Likely IIA 5 5 IIA period. No N/A
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
Device becomes damaged in reference to using There is no risk control shows 0
incorrect type of endoscope. a particular type of failure
Device malfunctions in patient. endoscope in the Implementation (s) out
IFU or Labelling None. of
Harm 14724
Continuation of occlusion (which devices
can be treated within the same 3 Likely IIB 5 5 IIB used in Yes D00170896
procedure) patients
over a 3
Impact year (03
Harm requiring medical Jul 2014
intervention, within the same to 03 Jul
operating procedure. No further 2017)
hospital stay required period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
Device becomes damaged in reference to using There is no risk control shows 0
incorrect type of endoscope. a particular type of failure
Device malfunctions in patient. endoscope in the Implementation (s) out
IFU or Labelling None. of
Harm 14724
Perforation and/or minor bleed devices
(self-limited) used in
patients
Impact over a 3
Harm requiring medical year (03
intervention, within the same Jul 2014
operating procedure. No further to 03 Jul
hospital stay required 2017)
3 Likely IIB 5 5 IIB period. Yes D00170896
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
16.12. Critical 16.12.1. User error: Does not position Situation Physician/assistant Risk Control History shows 0 failure
task - radiopaque marker correctly. Stent does not appropriately unable to The material of the radiopaque markers is (s) out of 14724 devices
Verify if bridge the stricture. distinguish the Tantalum and used for many devices and used in patients over a 3
radiopa markers on the implants where visibility under fluoroscopy is year (03 Jul 2014 to 03
que Harm fluoroscopy image. required and therefore is state-of the-art. Jul 2017) period.
marker Additional exposure to sedation,
s on radiation and/or contrast
inner Design solutions employed using state of the art
catheter Impact approaches which address the cause of
are Temporary discomfort- medical failure/failure mode. Such solutions relate to
located intervention not required features/ geometry/ materials which provide a
beyond high degree of assurance of robust designs
extremit established effective through clinical use.
ies of
the Implementation
stricture RMS0023 'Tantalum Radiopaque Band'
.
16.12.2. Physician/Assistant error: Situation Physician/Assistant Risk Control The effectiveness is
Does not use fluoroscopy Stent deployed in incorrect unaware of the Instructions for use includes a step that instructs inherent in the risk
location. Another stent is required requirement for use the user to confirm desired stent position control
to complete the procedure. of fluoroscopy fluoroscopically.
during the Device Information- Labelling/Instructions for Use
Harm procedure (IFU) indicate to the user device usage details/
Continuation of occlusion (which 3 Likely IIB operating principles, but cannot guarantee they 3 3 IIB Yes No N/A
can be treated within the same will utilise the information
procedure)
Implementation
Harm requiring medical IFU0052- Evolution™ Colonic Stent System
Min
Has risk
Probability Is a
of Risk ?
?
Control
16.13. Critical 16.13.1. Physician/Assistant error: Situation Physician/Assistant Risk Control The effectiveness is
task - Does not confirm stent Stent deployed in incorrect unaware of the Instructions for use includes a step that instructs inherent in the risk
Confirm position. location. Another stent is required requirement to the user to confirm desired stent position control
stent to complete the procedure. confirm stent fluoroscopically.
position position before Device Information- Labelling/Instructions for Use
fluorosc Harm continuing (IFU) indicate to the user device usage details/
opically. Continuation of occlusion (which deployment. operating principles, but cannot guarantee they
can be treated within the same 3 Likely IIB will utilise the information 3 3 IIB Yes No N/A
procedure)
Implementation
16.14. Critical 16.14.1. Physician/Assistant Situation Physician/Assistant Risk Control The effectiveness is
task - unintentionally moves Repositioning of delivery system unaware of the Instruction to user to remove the red safety guard inherent in the risk
Deploy introducer system away from to desired position is necessary requirement to is provided in IFU control
stent by desired position while before deployment. remove the red Device Information- Labelling/Instructions for Use
remove removing the safety guard safety guard prior (IFU) indicate to the user device usage details/
red Harm 1 Likely III to deployment operating principles, but cannot guarantee they 3 3 III Yes No N/A
safety No harm to patient will utilise the information
guard.
16.14.2. Physician/Assistant error: Situation Risk Control The effectiveness is
Does not remove safety guard Stent cannot be deployed. Physician/Assistant Instructions to user to remove the red safety inherent in the risk
Removal of safety guard is unaware of the guard is provided in IFU control
required. requirement to Device Information- Labelling/Instructions for Use
remove the red (IFU) indicate to the user device usage details/
Harm 1 Likely III safety guard prior operating principles, but cannot guarantee they 3 3 III Yes No N/A
No harm to patient to deployment. will utilise the information
16.14.3. Physician/Assistant removed Situation Physician/Assistant Risk Control The effectiveness is
safety guard before confirming Physician/Assistant accidentally unaware of the Instructions for use includes a step that describes inherent in the risk
stent is in desired position. press the trigger before requirement to the appropriate time for removal of the red safety control
introducer system reaches remove the red guard
desired position. Stent partially safety guard prior Device Information- Labelling/Instructions for Use
deploys during deployment. to deployment (IFU) indicate to the user device usage details/
Physician/Assistant recapture operating principles, but cannot guarantee they
stent and continue with will utilise the information
procedure.
Implementation
Harm IFU0053- Evolution™ Duodenal Stent System
No harm to patient IFU0052- Evolution™ Colonic Stent System
Impact
Physician/Assistant accidentally unaware of the Instructions for use includes a step that describes inherent in the risk
press the trigger before requirement to the appropriate time for removal of the red safety control
introducer system reaches remove the red guard
desired position. Stent partially safety guard prior Device Information- Labelling/Instructions for Use
deploys during deployment. to deployment (IFU) indicate to the user device usage details/
Physician/Assistant recapture operating principles, but cannot guarantee they
stent and continue with will utilise the information
procedure. 2 Likely IIA 3 3 IIA Yes No N/A
Implementation
Harm IFU0053- Evolution™ Duodenal Stent System
Minor trauma to mucosa IFU0052- Evolution™ Colonic Stent System
Impact
Min
Has risk
Probability Is a
of Risk ?
?
Control
16.15. Critical 16.15.1. Physician/Assistant Error: Situation Physician/Assistant Risk Control The effectiveness is
task - Device moved from correct Physician/Assistant moves unaware of correct Instructions for use include steps describing if inherent in the risk
Deploy location while deploying stent Introducer system from desired procedure stent repositioning is required during deployment, control
stent position and goes unnoticed. it is possible to recapture stent.
via Stent is deployed in incorrect Device Information- Labelling/Instructions for Use
trigger location. Another stent is (IFU) indicate to the user device usage details/
while required to complete the operating principles, but cannot guarantee they
maintai procedure. will utilise the information
ning
correct Harm 3 Likely IIB Implementation 3 3 IIB Yes No N/A
position Continuation of occlusion (which IFU0053- Evolution™ Duodenal Stent System
. can be treated within the same IFU0052- Evolution™ Colonic Stent System
procedure)
Impact
Physician/Assistant moves unaware of correct Instructions for use include steps describing if inherent in the risk
Introducer system from desired procedure stent repositioning is required during deployment, control
position and does not notice until it is possible to recapture stent.
the point of no return has been Device Information- Labelling/Instructions for Use
passed. Physician/Assistant try to (IFU) indicate to the user device usage details/
recapture stent causing damage operating principles, but cannot guarantee they
on stent. Device removed with will utilise the information
stent partially deployed. Another
stent is required to complete the 2 Likely IIA Implementation 3 3 IIA Yes No N/A
procedure. IFU0053- Evolution™ Duodenal Stent System
Harm
Impact
position before the point of no it is possible to recapture stent.
return has been passed. Device Information- Labelling/Instructions for Use
Physician/Assistant recaptures (IFU) indicate to the user device usage details/
stent and continues with operating principles, but cannot guarantee they
procedure. 1 Likely III will utilise the information 3 3 III Yes No N/A
Harm Implementation
No harm to patient or end user IFU0053- Evolution™ Duodenal Stent System
Impact
position and does not notice until it is possible to recapture stent.
the point of no return has been Device Information- Labelling/Instructions for Use
passed. Physician/Assistant try to (IFU) indicate to the user device usage details/
recapture stent causing damage operating principles, but cannot guarantee they
on stent. Device removed with will utilise the information
stent partially deployed. Another
stent is required to complete the 2 Likely IIA Implementation 3 3 IIA Yes No N/A
procedure. IFU0053- Evolution™ Duodenal Stent System
Harm
Minor trauma to mucosa
Impact
Min
Has risk
Probability Is a
of Risk ?
?
Control
16.15.2. Physician/Assistant Error: Situation Risk Control The effectiveness is
Stent not deployed Stent cannot be placed at Physician/Assistant Instructions for use includes steps that describes inherent in the risk
stricture. Replacement of device unaware of correct correct stent placement method. control
required. stent deployment Device Information- Labelling/Instructions for Use
method. (IFU) indicate to the user device usage details/
Device replaced 1 Likely III will utilise the information 3 3 III Yes No N/A
without a health
consequence. Implementation
Stent Position not checked Stent cannot be recaptured if Physician/Assistant Instructions for use includes steps that describes inherent in the risk
before passing the point of no necessary and is deployed in unaware of correct correct stent placement method. control
return incorrect location. Another stent stent deployment Device Information- Labelling/Instructions for Use
required to complete the method. (IFU) indicate to the user device usage details/
procedure. operating principles, but cannot guarantee they
Harm
Continuation of occlusion (which 3 Likely IIB Implementation 3 3 IIB Yes No N/A
can be treated within the same IFU0053- Evolution™ Duodenal Stent System
procedure) IFU0052- Evolution™ Colonic Stent System
Impact
Situation Risk Control The effectiveness is
Stent cannot be recaptured if Physician/Assistant Instructions for use includes steps that describes inherent in the risk
necessary and is deployed in unaware of correct correct stent placement method. control
incorrect location. Another stent stent deployment Device Information- Labelling/Instructions for Use
required to complete the method. (IFU) indicate to the user device usage details/
Harm
Additional exposure to sedation, Implementation
radiation and/or contrast IFU0053- Evolution™ Duodenal Stent System
Impact
Stent cannot be recaptured if Physician/Assistant Instructions for use includes steps that describes inherent in the risk
necessary. Physician/Assistant unaware of correct correct stent placement method. control
tries to recapture stent causing stent deployment Device Information- Labelling/Instructions for Use
damage on stent. Deployed stent method. (IFU) indicate to the user device usage details/
removed. Replacement device is operating principles, but cannot guarantee they
necessary. will utilise the information
Harm Implementation
Irritation / edema/ ulceration at 3 Likely IIB IFU0053- Evolution™ Duodenal Stent System 3 3 IIB Yes No N/A
mucosa requiring medical IFU0052- Evolution™ Colonic Stent System
medications)
Impact
16.16. Critical 16.16.1. User error: Physician/Assistant Situation Physician/Assistant Risk Control The effectiveness is
task - If change direction trigger after Stent cannot be recaptured. unaware of correct Instructions for use inncludes steps that describes inherent in the risk
recaptu passing point of no return Stent deployed in incorrect stent deployment correct stent deployment method. control
re of location. Another stent required method. Device Information- Labelling/Instructions for Use
stent is to complete the procedure. 3 Likely IIB (IFU) indicate to the user device usage details/ 3 3 IIB Yes No N/A
necess operating principles, but cannot guarantee they
ary Harm will utilise the information
push Continuation of occlusion (which
Min
Has risk
Probability Is a
of Risk ?
?
Control
directio can be treated within the same Implementation
n button procedure) IFU0053- Evolution™ Duodenal Stent System
and IFU0052- Evolution™ Colonic Stent System
hold Impact
with Harm requiring medical
thumb intervention, within the same
for first operating procedure. No further
squeez hospital stay required
e.
Safety wire has not been unaware of correct Instructions for use inncludes steps that describes inherent in the risk
removed. Stent is recaptured as stent deployment correct stent deployment method. control
normal. method. Device Information- Labelling/Instructions for Use
Harm 1 Likely III operating principles, but cannot guarantee they 3 3 III Yes No N/A
No harm to patient will utilise the information
16.16.2. User error: Physician/Assistant Situation Physician/Assistant Risk Control The effectiveness is
does not press direction button Stent cannot be recaptured. unaware of correct Instructions for use include steps that describes inherent in the risk
down fully (direction not Physician/Assistant pushes stent deployment correct stent deployment method control
changed) direction button fully and stent is method. Device Information- Labelling/Instructions for Use
recaptured. (IFU) indicate to the user device usage details/
No harm to patient
Implementation
No health consequence/ IFU0052- Evolution™ Colonic Stent System
does not hold direction button Recapture direction gears unaware of correct Instructions for use include steps that describes inherent in the risk
for first squeeze disengage. Stent cannot be stent deployment correct stent deployment method control
recaptured. Physician/Assistant method. Device Information- Labelling/Instructions for Use
press down fully and holds for (IFU) indicate to the user device usage details/
first squeeze operating principles, but cannot guarantee they
1 Likely III will utilise the information 3 3 III Yes No N/A
Harm
No harm to patient Implementation
16.17. Critial 16.17.1. User error: Physician/Assistant Situation Physician/Assistant Risk Control The effectiveness is
Task - does not recapture stent into Stent deployed at incorrect unaware of correct Instructions for use includes steps that describes inherent in the risk
Recapt introducing system. location. Another stent required stent deployment/ correct stent deployment and recapture method. control
ure to complete the procedure. recapture method. Device Information- Labelling/Instructions for Use
stent (IFU) indicate to the user device usage details/
via Harm operating principles, but cannot guarantee they
trigger if Continuation of occlusion (which will utilise the information
necess can be treated within the same 3 Likely IIB 3 3 IIB Yes No N/A
ary. procedure) Implementation
16.17.2. User Error: Situation (Colonic only) Risk Control The effectiveness is
Physician/ Assistant Physician/ Assistant successfully Physician/Assistant Instructions for use includes a note that the inherent in the risk
recaptures the stent more than completes procedure. unaware of correct effectiveness of the delivery system cannot be control
five times procedural method guaranteed if stent is recaptured more than five
Harm times
No harm to patient or end user Device Information- Labelling/Instructions for Use
1 Likely III (IFU) indicate to the user device usage details/ 3 3 III Yes No N/A
Impact operating principles, but cannot guarantee they
No health consequence/ will utilise the information
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
(Duodenal only) Risk Control None. The
Physician/Assistant There is no risk control severity
unaware of correct associat
procedural method ed with
Implementation this risk
None. is such
that
there is
no
potential
for harm
to the
5 5 III patient / No N/A
end-
user.
Further
risk
reductio
n
activitie
s will
not have
any
clinical
impact.
Situation (Colonic only) Risk Control The effectiveness is
Device malfunctions in patient. Physician/Assistant Instructions for use includes a note that the inherent in the risk
Replacement device required. unaware of correct effectiveness of the delivery system cannot be control
procedural method guaranteed if stent is recaptured more than five
Harm times
Additional exposure to sedation, Device Information- Labelling/Instructions for Use
3 3 IIA Yes No N/A
radiation and/or contrast (IFU) indicate to the user device usage details/
(Duodenal only) Risk Control None. History
Physician/Assistant There is no risk control shows 0
unaware of correct failure
procedural method (s) out
Implementation of
None. 14724
devices
used in
2 Likely IIA patients
over a 3
year (03
Jul 2014
to 03 Jul
2017)
5 5 IIA period. No N/A
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
Partially deployed stent removed unaware of correct effectiveness of the delivery system cannot be control
from patient. Replacement device 2 Likely IIA procedural method guaranteed if stent is recaptured more than five 3 3 IIA Yes No N/A
required. times
Min
Has risk
Probability Is a
of Risk ?
?
Control
Minor trauma to esophageal operating principles, but cannot guarantee they
mucosa will utilise the information
Temporary discomfort- medical IFU0052- Evolution™ Colonic Stent System
(Duodenal only) Risk Control None. History
Implementation of
None. 14724
devices
used in
patients
over a 3
year (03
Jul 2014
to 03 Jul
2017)
5 5 IIA period. No N/A
The
introduc
tion of
further
risk
control
measur
es will
not have
any
clinical
impact
unaware of correct effectiveness of the delivery system cannot be control
Harm procedural method guaranteed if stent is recaptured more than five
Irritation / edema/ ulceration at times
mucosa requiring medical Device Information- Labelling/Instructions for Use
3 3 IIB Yes No N/A
intervention (such as (IFU) indicate to the user device usage details/
medications) operating principles, but cannot guarantee they
Impact
hospital stay required (Duodenal only) Risk Control None. History
Implementation of
None. 14724
3 Likely IIB devices
used in
patients
over a 3
year (03
Jul 2014
5 5 IIB to 03 Jul Yes D00170896
2017)
period.
The
introduc
tion of
further
risk
control
measur
es will
Min
Has risk
Probability Is a
of Risk ?
?
Control
not have
any
clinical
impact
does not recapture stent into Stent is relocated to desired unaware of correct Instructions for use includes steps that describes inherent in the risk
introduction system to required position with stent partially stent deployment/ correct stent deployment and recapture method. control
amount. deployed. recapture method. Device Information- Labelling/Instructions for Use
Harm 1 Likely III operating principles, but cannot guarantee they 3 3 III Yes No N/A
No harm to patient will utilise the information
Stent is relocated to desired unaware of correct Instructions for use includes steps that describes inherent in the risk
position with stent partially stent deployment/ correct stent deployment and recapture method. control
deployed. recapture method. Device Information- Labelling/Instructions for Use
Harm 2 Likely IIA operating principles, but cannot guarantee they 3 3 IIA Yes No N/A
Minor trauma to mucosa will utilise the information
Temporary discomfort- medical IFU0053- Evolution™ Duodenal Stent System
intervention not required IFU0052- Evolution™ Colonic Stent System
Stent is relocated to desired unaware of correct Instructions for use includes steps that describes inherent in the risk
position with stent partially stent deployment/ correct stent deployment and recapture method. control
deployed. recapture method. Device Information- Labelling/Instructions for Use
Perforation and/or minor bleed will utilise the information
(self-limited)
Implementation
16.18. Relocat 16.18.1. Incorrect relocation of stent. Situation Physician/Assistant Risk Control The effectiveness is
e stent Stent deployed in incorrect unaware of correct Instructions for use includes steps that describes inherent in the risk
to location. Endoscopic retrieval stent correct stent deployment/recpture method control
desired required deployment/recapt Device Information- Labelling/Instructions for Use
position ure method (IFU) indicate to the user device usage details/
if stent Harm operating principles, but cannot guarantee they
has Foreign body / matter left in will utilise the information
been patient which can be retrieved 3 Likely IIB 3 3 IIB Yes No N/A
recaptu within the same procedure. Implementation
red. IFU0053- Evolution™ Duodenal Stent System
16.19. Critical 16.19.1. User error: Physician/Assistant Situation Risk Control The effectiveness is
task - does not press direction button Stent cannot be recaptured. Physician/Assistant Instructions for use includes steps that describe inherent in the risk
Resum down fully (direction not Physician/Assistant unable to unaware of correct correct stent deployment method control
e changed) push direction button fully and stent deployment Device Information- Labelling/Instructions for Use
deploy stent is deployed method. (IFU) indicate to the user device usage details/
ment of operating principles, but cannot guarantee they
stent Harm will utilise the information
pushing No harm to patient
directio Implementation
n button Impact IFU0053- Evolution™ Duodenal Stent System
and No health consequence/ IFU0052- Evolution™ Colonic Stent System
hold Nuisance to patient or end user
with
thumb Situation Risk Control The effectiveness is
for first Stent cannot be recaptured and 3 Likely IIB Physician/Assistant Instructions for use includes steps that describe 3 inherent in the risk 3 IIB Yes No N/A
squeez relocate to desired position of unaware of correct correct stent deployment method control
Min
Has risk
Probability Is a
of Risk ?
?
Control
e. deployment. Physician/Assistant stent deployment Device Information- Labelling/Instructions for Use
complete the procedure with method. (IFU) indicate to the user device usage details/
another stent. operating principles, but cannot guarantee they
Harm
Continuation of occlusion (which Implementation
Impact
16.19.2. User error: Physician/Assistant Situation Risk Control The effectiveness is
does not hold direction button Recapture direction gears Physician/Assistant Instructions for use includes steps that describe inherent in the risk
for first squeeze disengage. Stent cannot be unaware of correct correct stent deployment method control
recaptured. Physician/Assistant stent deployment Device Information- Labelling/Instructions for Use
realises error and then presses method. (IFU) indicate to the user device usage details/
down fully and holds button for operating principles, but cannot guarantee they
first squeeze will utilise the information
Harm Implementation
No harm to patient IFU0053- Evolution™ Duodenal Stent System
Impact
16.20. Critical 16.20.1. Physician/Assistant error: Situation Physician/Assistant Risk Control The effectiveness is
task - Fluoroscopic markers and Stent deployed in incorrect unaware of Instructions for use includes a step that describes inherent in the risk
Reconfi endoscopic marker positions location. Another is required to requirement to to confirm desired stent position using markers. control
rm not verified. complete the procedure. confirm position Device Information- Labelling/Instructions for Use
fluorosc using markers (IFU) indicate to the user device usage details/
opic Harm operating principles, but cannot guarantee they
marker Continuation of occlusion (which will utilise the information
s and can be treated within the same 3 Likely IIB 3 3 IIB Yes No N/A
endosc procedure) Implementation
opic IFU0053- Evolution™ Duodenal Stent System
marker Impact IFU0052- Evolution™ Colonic Stent System
s are Harm requiring medical
located intervention, within the same
in operating procedure. No further
desired hospital stay required
position
before 16.20.2. Physician/Assistant error: Situation Physician/Assistant Risk Control The effectiveness is
deploy Does not use fluoroscopy to Radiopaque markers are not unaware of Instructions for use includes a step that describes inherent in the risk
ment verify desired position visible.Stent replacement requirement to to confirm desired stent position fluoroscopically. control
fluorosc required. confirm position Device Information- Labelling/Instructions for Use
opically. using fluoroscopy (IFU) indicate to the user device usage details/
Additional exposure to sedation, will utilise the information
Implementation
16.21. Critical 16.21.1. Physician/Assistant Error: Situation Risk Control The effectiveness is
task - Does not remove safety wire to Stent not released from Physician/Assistant Instructions for use include steps that describes inherent in the risk
Remov continue deployment of the introducer system and remains unaware of correct correct stent deployment method control
e safety stent attached to delivery system on stent deployment Device Information- Labelling/Instructions for Use
wire to recapture. Physician/Assistant method. (IFU) indicate to the user device usage details/
continu notices and remove wire safety. operating principles, but cannot guarantee they
e Continue with procedure. will utilise the information
deploy
ment Harm Implementation
once No harm to patient or end user IFU0053- Evolution™ Duodenal Stent System
passed IFU0052- Evolution™ Colonic Stent System
the Impact
"point No health consequence/
of no Nuisance to patient or end user
return"
Stent not released from 2 Likely IIA Physician/Assistant Instructions for use include steps that describes 3 inherent in the risk 3 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
introducer system and remains unaware of correct correct stent deployment method control
attached to delivery system on stent deployment Device Information- Labelling/Instructions for Use
recapture. Physician/Assistant method. (IFU) indicate to the user device usage details/
does not notice and moves stent operating principles, but cannot guarantee they
from correct location. will utilise the information
Physician/Assistant removes
safety wire and replacement of Implementation
stent is required. IFU0053- Evolution™ Duodenal Stent System
Harm
Impact
Stent not released from Physician/Assistant Instructions for use include steps that describes inherent in the risk
does not notice and remove stent operating principles, but cannot guarantee they
along with introducer system. will utilise the information
Harm Implementation
Continuation of occlusion (which IFU0053- Evolution™ Duodenal Stent System
can be treated within the same IFU0052- Evolution™ Colonic Stent System
procedure)
Impact
Stent not released from Physician/Assistant Instructions for use include steps that describes inherent in the risk
does not notice and remove stent operating principles, but cannot guarantee they
along with introducer system. will utilise the information
Harm Implementation
Irritation / edema/ ulceration at 3 Likely IIB IFU0053- Evolution™ Duodenal Stent System 3 3 IIB Yes No N/A
mucosa requiring medical IFU0052- Evolution™ Colonic Stent System
medications)
Impact
Safety wire is removed before Physician/Assistant unable to Physician/Assistant Instructions for use includes steps that describes inherent in the risk
stent has been correctly recapture stent. Stent is deployed unaware of correct correct stent deployment method control
positioned for deployment in incorrect location another stent stent deployment Device Information- Labelling/Instructions for Use
required to complete the method (IFU) indicate to the user device usage details/
Harm
Continuation of occlusion (which 3 Likely IIB Implementation 3 3 IIB Yes No N/A
Impact
16.22. Critical 16.22.1. User error: Physician/Assistant Situation 3 Likely IIB Physician/Assistant Risk Control 3 The effectiveness is 3 IIB Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
task - does not confirm stent Stent deployed on incorrect unaware of Instructions for use includes a step that describes inherent in the risk
Check expansion. location. Lesion goes untreated. requirement to to confirm desired stent expansion control
if stent confirm stent fluoroscopically.
is fully Harm expansion under Device Information- Labelling/Instructions for Use
expand Continuation of occlusion (which fluoroscopy (IFU) indicate to the user device usage details/
ed can be treated within the same operating principles, but cannot guarantee they
under procedure) will utilise the information
fluorosc
opy. Impact Implementation
Harm requiring medical IFU0053- Evolution™ Duodenal Stent System
Stent deployed on incorrect unaware of Instructions for use includes a step that describes inherent in the risk
location. Lesion goes untreated. requirement to to confirm desired stent expansion control
confirm stent fluoroscopically.
Harm expansion under Device Information- Labelling/Instructions for Use
Reocclusion occurs, requiring fluoroscopy (IFU) indicate to the user device usage details/
secondary intervention operating principles, but cannot guarantee they
Impact
Harm requiring secondary Implementation
intervention and/ or prolonged IFU0053- Evolution™ Duodenal Stent System
hospitalisation required IFU0052- Evolution™ Colonic Stent System
16.22.2. User error: Physician/Assistant Situation Risk Control The effectiveness is
does not confirm position of Stent deployed on incorrect Physician/Assistant Instructions for use includes steps that describes inherent in the risk
stent. location. Lesion goes untreated. unaware of correct correct stent deployment method control
Another stent is required to stent deployment Device Information- Labelling/Instructions for Use
complete the procedure. method (IFU) indicate to the user device usage details/
can be treated within the same Implementation
procedure) IFU0053- Evolution™ Duodenal Stent System
Impact
16.23. Critical 16.23.1. Physician/Assistant Situation Risk Control The effectiveness is
task - dislodges/damages the stent Stent remains intact, Physician/Assistant Instructions for use includes steps that describes inherent in the risk
Remov while remove delivery system. Physician/Assistant removes wire unaware of correct correct procedural method control
e guide and continues with procedural method Device Information- Labelling/Instructions for Use
delivery procedure. (IFU) indicate to the user device usage details/
system. operating principles, but cannot guarantee they
No harm to patient
Implementation
No health consequence/ IFU0052- Evolution™ Colonic Stent System
Replacement stent required, Physician/Assistant Instructions for use includes steps that describes inherent in the risk
Physician/Assistant removes unaware of correct correct procedural method control
device and restarts procedure. procedural method Device Information- Labelling/Instructions for Use
Additional exposure to sedation, will utilise the information
Implementation
16.24. Critical 16.24.1. Use error situation: Situation Size or style of Risk Control History shows 0 failure
task - Physician/Assistant fails to Implant information recorded on font. The text and style of the font for Patient Card are (s) out of 14724 devices
record record traceability information other format available to the chosen to be easily read. used in patients over a 3
traceabi because they cannot read text Physician/Assistant. 1 Likely III 1 year (03 Jul 2014 to 03 1 III Yes No N/A
lity of Patient Card/Labelling Jul 2017) period.
informa Design solutions employed using state of the art
Min
Has risk
Probability Is a
of Risk ?
?
Control
tion. Harm approaches which address the cause of
No harm to patient failure/failure mode. Such solutions relate to
Implementation
Insufficient contrast Risk Control History shows 0 failure
background. the background of the Patient Card is white and used in patients over a 3
the text is black. year (03 Jul 2014 to 03
Jul 2017) period.
1 1 III Yes No N/A
Implementation
16.24.2. Use error situation: Situation User is confused Risk Control History shows 0 failure
Physician/Assistant transcribes Documentation completed by codes or long The label includes removable Record labels that (s) out of 14724 devices
device traceability information incorrectly. numbers that contain the necessary traceability information used in patients over a 3
on the patient's chart constitute the such that the user does not have to transcribe year (03 Jul 2014 to 03
incorrectly. Harm traceability information. Jul 2017) period.
No harm to patient information of the
device. Design solutions employed using state of the art
Impact 1 Likely III approaches which address the cause of 1 1 III Yes No N/A
Implementation
16.25. Critical 16.25.1. Use error situation: user Situation Failure to follow the Risk Control History shows 0 failure
task - removes device from patient Device used on multiple patients, users institutional IFU states dispose per institutional guidelines for (s) out of 14724 devices
dispose and uses on another patient. risk of infection from cross guidelines on biohazardous medical device. used in patients over a 3
of (Device Re-use) contamination disposal of medical year (03 Jul 2014 to 03
device. devices. Design solutions employed using state of the art Jul 2017) period.
Infection treatable with failure/failure mode. Such solutions relate to
medication features/ geometry/ materials which provide a
operating procedure. No further DWG0341 'Evolution Duodenal/Colonic
hospital stay required Introducer'
16.25.2. Use error situation: Situation User is unaware of Risk Control History shows 0 failure
Device removed from patient Device used on multiple patients, single use device The device is supplied with one stent pre-loaded (s) out of 14724 devices
and used on another patient. risk of infection from cross application in a delivery system. The device is completely used in patients over a 3
(Device Re-use) contamination expended once the stent is deployed from the year (03 Jul 2014 to 03
delivery system. Post-deployment, the delivery Jul 2017) period.
Harm system has no further functionality and therefore
Infection, treatable with cannot be re-used by design.
antibiotics
3 Likely IIB Design solutions employed using state of the art 1 1 IIA Yes No N/A
Harm requiring medical failure/failure mode. Such solutions relate to
intervention, within the same features/ geometry/ materials which provide a
operating procedure. No further high degree of assurance of robust designs
hospital stay required established effective through clinical use.
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
IFU states 'This Device is designed for single use inherent in the risk
only' control
operating principles, but cannot guarantee they 3
Implementation
Situation User is unaware of Risk Control History shows 0 failure
Device used on multiple patients, single use device The device is supplied with one stent pre-loaded (s) out of 14724 devices
failure during subsequent use application in a delivery system. The device is completely used in patients over a 3
expended once the stent is deployed from the year (03 Jul 2014 to 03
Harm delivery system. Post-deployment, the delivery Jul 2017) period.
Major Infection system has no further functionality and therefore
cannot be re-used by design.
Impact
Harm requiring secondary Design solutions employed using state of the art 1
intervention and/ or prolonged approaches which address the cause of
hospitalisation required failure/failure mode. Such solutions relate to
4 Unlikely IIB 1 IIA Yes No N/A
Implementation
only' control
Implementation
Situation User is unaware of Risk Control History shows 0 failure
Device used on multiple patients, single use device The device is supplied with one stent pre-loaded (s) out of 14724 devices
failure during subsequent use application in a delivery system. The device is completely used in patients over a 3
expended once the stent is deployed from the year (03 Jul 2014 to 03
Harm delivery system. Post-deployment, the delivery Jul 2017) period.
Cross contamination of blood system has no further functionality and therefore
borne pathogens / Exposure to cannot be re-used by design.
pathogens
Design solutions employed using state of the art 1
Permanent irreversible failure/failure mode. Such solutions relate to
impairment, life-threatening features/ geometry/ materials which provide a
illness or injury high degree of assurance of robust designs
5 Remote I 1 IIA Yes No N/A
Implementation
only' control
Implementation
16.25.3. Use error situation: Situation Failure to follow the Risk Control The effectiveness is
Device not disposed of in the Device causes contamination of 5 Remote I users institutional 3 inherent in the risk 3 IIB Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
appropriate manner. person or environment guidelines on IFU states dispose per institutional guidelines for control
disposal of medical biohazardous medical device.
Harm devices. Device Information- Labelling/Instructions for Use
Cross contamination of blood (IFU) indicate to the user device usage details/
borne pathogens / Exposure to operating principles, but cannot guarantee they
pathogens will utilise the information
Permanent irreversible IFU0052- Evolution™ Colonic Stent System
impairment, life-threatening IFU0053- Evolution™ Duodenal Stent System
illness or injury
16.26. Critical 16.26.1. Use error situation: Situation Physician/patient Risk Control The effectiveness is
task- Physician/Assistant performs Alternative treatment(s) post unaware of Instructions for use includes a precaution advising inherent in the risk
Provide alternative treatment method placement of stent alters the GI precaution against against subsequent alternative treatment method control
correct post placement of stent tract geometry leading to stent administering (s)
post migration alternative Device Information- Labelling/Instructions for Use
surgery treatments (IFU) indicate to the user device usage details/
instructi Harm 2 Likely IIA operating principles, but cannot guarantee they 3 3 IIA Yes No N/A
on and Irritation / edema/ ulceration/ will utilise the information
follow- erosion at mucosa (health tissue)
up Implementation
evaluati Impact IFU0052- Evolution™ Colonic Stent System
on Temporary discomfort- medical IFU0053- Evolution™ Duodenal Stent System
16.26.2. Use error situation: Situation Physician/patient Risk Control The effectiveness is
Physician/Assistant does not Stent moves from correct unaware of Instructions for use includes a precaution advising inherent in the risk
provide periodic evaluation. location. requirement for of the need for periodic evaluation control
follow-up Device Information- Instructions for Use (IFU)
Harm evaluation indicate to the user device usage details/
Reocclusion occurs, requiring operating principles.
4 Likely I 3 3 IIB Yes No N/A
secondary intervention
Implementation
Harm requiring secondary IFU0053- Evolution™ Duodenal Stent System
Situation Physician/patient Risk Control The effectiveness is
Stent fracture post implantation unaware of Instructions for use includes a precaution advising inherent in the risk
requirement for of the need for periodic evaluation control
Harm follow-up Device Information- Instructions for Use (IFU)
Reocclusion occurs, requiring evaluation indicate to the user device usage details/
secondary intervention. 4 Likely I operating principles. 3 3 IIB Yes No N/A
Harm requiring secondary IFU0052- Evolution™ Colonic Stent System
intervention and / or prolonged IFU0053- Evolution™ Duodenal Stent System
Situation Physician/patient Risk Control The effectiveness is
Stent fracture post implantation unaware of Instructions for use includes a precaution advising inherent in the risk
requirement for of the need for periodic evaluation control
Harm follow-up Device Information- Instructions for Use (IFU)
Additional exposure to sedation, evaluation indicate to the user device usage details/
radiation and/or contrast operating principles.
Temporary discomfort – medical IFU0052- Evolution™ Colonic Stent System
intervention not required IFU0053- Evolution™ Duodenal Stent System
17. Stent 17.1. Be kink 17.1.1. Is not kink resistant. Situation Incorrect material - Risk Control History shows 0 failure
resistant Stent kinks during advancement. stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
Stent cannot be deployed. Device stiff Nitinol offers elastic material properties which used in patients over a 3
replaced provides adequate stiffness for this application year (03 Jul 2014 to 03
Jul 2017) period.
1 Likely III failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
Incorrect geometry Risk Control History shows 0 failure
- cross-section Wire woven stent cross section area as specified (s) out of 14724 devices
area of stent cells by design provides an adequate level of kink used in patients over a 3
is too large resistance year (03 Jul 2014 to 03
Jul 2017) period.
failure/failure mode. Such solutions relate to 1 1 III Yes No N/A
Implementation
Incorrect design - Risk Control History shows 0 failure
stent design does Wire woven stent as specified by design provides (s) out of 14724 devices
not ensure an an adequate level of kink resistance used in patients over a 3
adequate level of year (03 Jul 2014 to 03
kink resistance Design solutions employed using state of the art Jul 2017) period.
1 1 III Yes No N/A
Implementation
Incorrect material - Risk Control History shows 0 failure
Material properties Stent material as specified by design is Nitinol. (s) out of 14724 devices
adversely change Nitinol material is super elastic and self used in patients over a 3
due to operation at expanding. It does not adversely change due to year (03 Jul 2014 to 03
body temperature operation at body temperature Jul 2017) period.

failure/failure mode. Such solutions relate to 1 has been completed for 1 III Yes No N/A
Ver 0
DWG0288 'Enteral Stent ' products are of similar
DWG0289 'Colonic Stent' design to EVO-xx-yy-zz-
C product(s) tested
Situation Incorrect material - Risk Control History shows 0 failure
Stent kinks during advancement. stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
Partial stent deployment during stiff Nitinol offers elastic material properties which used in patients over a 3
procedure. Stent cannot be provides adequate stiffness for this application year (03 Jul 2014 to 03
recaptured. Device removed with Jul 2017) period.
partially deployed stent. Design solutions employed using state of the art
Harm failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
Additional exposure to sedation, features/ geometry/ materials which provide a
radiation and/or contrast high degree of assurance of robust designs
Impact
Temporary discomfort- medical 2 Likely IIA Implementation
intervention not required DWG0288 'Enteral Stent '
1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
1 1 IIA Yes No N/A
Implementation

failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
Ver 0
C product(s) tested
Stent kinks during advancement stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
in procedure. Deployed stent is stiff Nitinol offers elastic material properties which used in patients over a 3
kinked causing obstruction in provides adequate stiffness for this application year (03 Jul 2014 to 03
tract. Jul 2017) period.
Impact
intervention, within the same DWG0288 'Enteral Stent '
operating procedure. No further DWG0289 'Colonic Stent'
3 Likely IIB area of stent cells by design provides an adequate level of kink used in patients over a 3
Jul 2017) period.
failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
Implementation
not ensure an an adequate level of kink resistance 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation

Ver 0
C product(s) tested
Stent kinks during deployment. stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
Cannot be recaptured , Kinked stiff Nitinol offers elastic material properties which used in patients over a 3
stent causes obstruction during provides adequate stiffness for this application year (03 Jul 2014 to 03
the procedure. Jul 2017) period.
Impact
Jul 2017) period.
3 Likely IIB failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
Implementation
features/ geometry/ materials which provide a 1 1 IIA Yes No N/A
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control

Ver 0
C product(s) tested
Stent kinks post deployment. stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
Kinked stent causes tract to re- stiff Nitinol offers elastic material properties which used in patients over a 3
occlude. provides adequate stiffness for this application year (03 Jul 2014 to 03
Jul 2017) period.
Foreign body / matter left in approaches which address the cause of
patient which can be retrieved failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
within the same procedure. features/ geometry/ materials which provide a
operating procedure. No further DWG0288 'Enteral Stent '
hospital stay required DWG0289 'Colonic Stent'
Jul 2017) period.
3 Likely IIB Implementation

1 1 IIA Yes No N/A
Implementation
1 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Ver 0
C product(s) tested
Stent kinks post deployment. stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
Kinked stent causes tract to re- stiff Nitinol offers elastic material properties which used in patients over a 3
occlude. provides adequate stiffness for this application year (03 Jul 2014 to 03
Jul 2017) period.
Continuation of occlusion (which approaches which address the cause of
can be treated within the same failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
procedure) features/ geometry/ materials which provide a
Jul 2017) period.
Implementation
3 Likely IIB Incorrect design - Risk Control History shows 0 failure
1 1 IIA Yes No N/A
Implementation

Ver 0
C product(s) tested
17.2. Be 17.2.1. Stent is rigid and does not Situation Incorrect material - Risk Control History shows 0 failure
flexible conform to the stricture wall Trauma occurs where the rigid 3 Likely IIB stent material is too Stent material is Nitinol as specified by design. 1 (s) out of 14724 devices 1 IIA Yes No N/A
geometry stented & non-stented tract wall stiff Nitinol offers elastic material properties which used in patients over a 3
Min
Has risk
Probability Is a
of Risk ?
?
Control
sections meet. provides adequate stiffness for this application year (03 Jul 2014 to 03
Jul 2017) period.
Perforation and/or minor bleed approaches which address the cause of Simulated Use Testing:
(self-limited) failure/failure mode. Such solutions relate to Deployment Testing [in a
features/ geometry/ materials which provide a clinical setting] has been
Impact high degree of assurance of robust designs completed for EVO-xx-
Harm requiring medical established effective through clinical use. yy-zz-D and EVO-xx-yy-
intervention, within the same zz-C devices per ref:
operating procedure. No further Implementation VAL08-0011 REPORT
hospital stay required DWG0288 'Enteral Stent ' Rev 1
DWG0289 'Colonic Stent' EVO-xx-yy-zz-D
C product(s) tested
[in a clinical setting] has
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
area of stent cells by design provides an adequate level of flexibility used in patients over a 3
is too large for this application year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of Simulated Use Testing:
failure/failure mode. Such solutions relate to Deployment Testing [in a
Implementation 1 VAL08-0011 REPORT 1 IIA Yes No N/A
DWG0288 'Enteral Stent ' Rev 1
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
not ensure an an adequate level of flexibility for this application. used in patients over a 3
flexibility Design solutions employed using state of the art Jul 2017) period.
failure/failure mode. Such solutions relate to Simulated Use Testing:
features/ geometry/ materials which provide a Deployment Testing [in a
high degree of assurance of robust designs clinical setting] has been
DWG0288 'Enteral Stent ' VAL08-0011 REPORT
DWG0289 'Colonic Stent' 1 Rev 1 1 IIA Yes No N/A
EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
Design solutions employed using state of the art Simulated Use Testing:
approaches which address the cause of Deployment Testing [in a
failure/failure mode. Such solutions relate to clinical setting] has been
1 VAL08-0011 REPORT 1 IIA Yes No N/A
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Trauma occurs where the rigid stent material is too Stent material is Nitinol as specified by design. (s) out of 14724 devices
stented & non-stented tract wall stiff Nitinol offers elastic material properties which used in patients over a 3
Jul 2017) period.
Irritation / edema/ ulceration at approaches which address the cause of Simulated Use Testing:
mucosa requiring medical failure/failure mode. Such solutions relate to Deployment Testing [in a
intervention (such as features/ geometry/ materials which provide a clinical setting] has been
medications) high degree of assurance of robust designs completed for EVO-xx-
Impact zz-C devices per ref:
Harm requiring medical Implementation 1 VAL08-0011 REPORT 1 IIA Yes No N/A
intervention, within the same DWG0288 'Enteral Stent ' Rev 1
operating procedure. No further DWG0289 'Colonic Stent' EVO-xx-yy-zz-D
hospital stay required products are of similar
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
3 Likely IIB REPORT Rev 1
Jul 2017) period.
1 zz-C devices per ref: 1 IIA Yes No N/A
Implementation VAL08-0011 REPORT
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
per ref: VAL08-0070
REPORT Rev 1
DWG0288 'Enteral Stent ' 1 VAL08-0011 REPORT 1 IIA Yes No N/A
DWG0289 'Colonic Stent' Rev 1
EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Jul 2017) period.
Perforation (medical intervention approaches which address the cause of Simulated Use Testing:
required) and/or major bleed failure/failure mode. Such solutions relate to Deployment Testing [in a
(transfusion required) features/ geometry/ materials which provide a clinical setting] has been
Impact 4 Unlikely IIB established effective through clinical use. 1 yy-zz-D and EVO-xx-yy- 1 IIA Yes No N/A
Harm requiring secondary zz-C devices per ref:
intervention and/ or prolonged Implementation VAL08-0011 REPORT
hospitalisation required DWG0288 'Enteral Stent ' Rev 1
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Jul 2017) period.
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
failure/failure mode. Such solutions relate to 1 clinical setting] has been 1 IIA Yes No N/A
VAL08-0011 REPORT
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Jul 2017) period.
Perforation (medical intervention approaches which address the cause of Simulated Use Testing:
required) and/or major bleed failure/failure mode. Such solutions relate to Deployment Testing [in a
(transfusion required) features/ geometry/ materials which provide a clinical setting] has been
Impact established effective through clinical use. yy-zz-D and EVO-xx-yy-
Harm requiring secondary zz-C devices per ref:
intervention and/ or prolonged Implementation 1 VAL08-0011 REPORT 1 IIA Yes No N/A
hospitalisation required DWG0288 'Enteral Stent ' Rev 1
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Jul 2017) period.
4 Unlikely IIB failure/failure mode. Such solutions relate to Deployment Testing [in a
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
features/ geometry/ materials which provide a 1 Deployment Testing [in a 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
17.3. Appose 17.3.1. Does not fully appose the Situation Incorrect design - Risk Control History shows 0 failure
the stricture wall Part of stent collapses into stent single woven Stent weave pattern as specified by design (s) out of 14724 devices
stricture lumen. Stent lumen is impeded. wire design does assures adequate level of wall opposition used in patients over a 3
wall not ensure all of year (03 Jul 2014 to 03
Harm the stent apposes Design solutions employed using state of the art Jul 2017) period.
Continuation of occlusion (which stricture wall approaches which address the cause of
can be treated within the same following expansion failure/failure mode. Such solutions relate to Simulated Use Testing:
procedure) features/ geometry/ materials which provide a Deployment Testing [in a
Impact established effective through clinical use. completed for EVO-xx-
Harm requiring medical yy-zz-D and EVO-xx-yy-
intervention, within the same Implementation zz-C devices per ref:
operating procedure. No further DWG0288 'Enteral Stent ' 1 VAL08-0011 REPORT 1 IIA Yes No N/A
hospital stay required DWG0289 'Colonic Stent' Rev 1
EVO-xx-yy-zz-D
C product(s) tested
3 Likely IIB Simulated Use Testing
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Incorrect material Risk Control History shows 0 failure
selection. Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
material is Nitinol is superelastic and self expanding. It has a used in patients over a 3
excessively self- single woven wire design which maintains fully year (03 Jul 2014 to 03
expanding beyond expanded stent diameter as per design Jul 2017) period.
specified diameter 1 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL08-0011 REPORT
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Situation Incorrect design - Risk Control History shows 0 failure
Part of stent impedes on tract stent single woven Stent weave pattern as specified by design (s) out of 14724 devices
wall tissue, poor wall apposition. wire design does assures adequate level of wall opposition used in patients over a 3
not ensure all of year (03 Jul 2014 to 03
Irritation / edema/ ulceration at stricture wall approaches which address the cause of
mucosa requiring medical following expansion failure/failure mode. Such solutions relate to Simulated Use Testing:
intervention (such as features/ geometry/ materials which provide a Deployment Testing [in a
medications) high degree of assurance of robust designs clinical setting] has been
Impact yy-zz-D and EVO-xx-yy-
Harm requiring medical Implementation zz-C devices per ref:
intervention, within the same DWG0288 'Enteral Stent ' 1 VAL08-0011 REPORT 1 IIA Yes No N/A
operating procedure. No further DWG0289 'Colonic Stent' Rev 1
hospital stay required EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
3 Likely IIB
specified diameter
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Part of stent impedes tract wall stent single woven Stent weave pattern as specified by design (s) out of 14724 devices
tissue, poor wall apposition. wire design does assures adequate level of wall opposition used in patients over a 3
Harm 4 Unlikely IIB the stent apposes Design solutions employed using state of the art 1 Jul 2017) period. 1 IIA Yes No N/A
Perforation (medical intervention stricture wall approaches which address the cause of
required) and/or major bleed following expansion failure/failure mode. Such solutions relate to Simulated Use Testing:
(transfusion required) features/ geometry/ materials which provide a Deployment Testing [in a
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact established effective through clinical use. completed for EVO-xx-
Harm requiring secondary yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged Implementation zz-C devices per ref:
hospitalisation required DWG0288 'Enteral Stent ' VAL08-0011 REPORT
EVO-xx-yy-zz-D
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
specified diameter
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Part of stent impedes tract wall stent single woven Stent weave pattern as specified by design (s) out of 14724 devices
tissue, poor wall apposition. wire design does assures adequate level of wall opposition used in patients over a 3
Minor trauma to mucosa stricture wall approaches which address the cause of
following expansion failure/failure mode. Such solutions relate to Simulated Use Testing:
Impact features/ geometry/ materials which provide a Deployment Testing [in a
Temporary discomfort- medical high degree of assurance of robust designs clinical setting] has been
intervention not required established effective through clinical use. completed for EVO-xx-
EVO-xx-yy-zz-D
2 Likely IIA products are of similar
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
material is Nitinol is superelastic and self expanding. It has a 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
specified diameter
VAL08-0011 REPORT
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
17.4. Be 17.4.1. Is not corrosion resistant Situation Incorrect stent Risk Control History shows 0 failure
corrosion Particulates of corrosion product surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
resistant or pieces detach from stent. Stent does not design used in patients over a 3
Particulates pass through GI tract have a smooth year (03 Jul 2014 to 03
surface Design solutions employed using state of the art Jul 2017) period.
Harm failure/failure mode. Such solutions relate to Immersion Corrosion
1 1 III Yes No N/A
No harm to patient features/ geometry/ materials which provide a Testing representative of
high degree of assurance of robust designs 52 weeks in vivo has
Impact established effective through clinical use. been completed for
No health consequence/ EVO-xx-yy-zz-D and
Nuisance to patient or end user Implementation EVO-xx-yy-zz-C devices
DWG0288 'Enteral Stent ' per ref: VAL07-0015
DWG0289 'Colonic Stent' REPORT Rev 1
1 Likely III Incorrect material Risk Control History shows 0 failure
selection: Stent material is Nitinol as specified by design, (s) out of 14724 devices
Stent material which comprises of a nickel and titanium mix and used in patients over a 3
corrodes within the is resistant to corrosion year (03 Jul 2014 to 03
body environment Jul 2017) period.
approaches which address the cause of Immersion Corrosion
failure/failure mode. Such solutions relate to 1 Testing representative of 1 III Yes No N/A
features/ geometry/ materials which provide a 52 weeks in vivo has
high degree of assurance of robust designs been completed for
established effective through clinical use. EVO-xx-yy-zz-D and
Implementation per ref: VAL07-0015
DWG0288 'Enteral Stent ' REPORT Rev 1
Situation Incorrect stent Risk Control History shows 0 failure
Stent corrodes within the GI tract surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
Stent does not design used in patients over a 3
Harm have a smooth year (03 Jul 2014 to 03
Allergic reaction / toxic or surface Design solutions employed using state of the art Jul 2017) period.
immune response approaches which address the cause of
failure/failure mode. Such solutions relate to Immersion Corrosion
1 1 IIA Yes No N/A
Impact features/ geometry/ materials which provide a Testing representative of
Permanent irreversible high degree of assurance of robust designs 52 weeks in vivo has
impairment, life-threatening established effective through clinical use. been completed for
illness or injury EVO-xx-yy-zz-D and
5 Remote I Implementation EVO-xx-yy-zz-C devices
selection: Stent material is Nitinol as specified by design, (s) out of 14724 devices
Stent material which comprises of a nickel and titanium mix and used in patients over a 3
corrodes within the is resistant to corrosion year (03 Jul 2014 to 03
body environment 1 Jul 2017) period. 1 IIA Yes No N/A
approaches which address the cause of Immersion Corrosion
failure/failure mode. Such solutions relate to Testing representative of
Min
Has risk
Probability Is a
of Risk ?
?
Control
features/ geometry/ materials which provide a 52 weeks in vivo has
DWG0288 'Enteral Stent ' REPORT Rev 1
17.5. Generate 17.5.1. Does not exert sufficient radial Situation Incorrect material Risk Control History shows 0 failure
sufficient force Stent does not fully expand upon selection. Stent (s) out of 14724 devices
radial deployment. Stent migration. material is not self- Stent material is Nitinol as specified by design. used in patients over a 3
force expanding, not Nitinol is superelastic and self expanding. It offers year (03 Jul 2014 to 03
Harm superelastic, not adequate stiffness for this application. AF Jul 2017) period.
Continuation of occlusion (which stiff enough, Af temperature selected is suitable for this
can be treated within the same temperature is too application Radial Force Testing of
procedure) high. the Stent has been
Design solutions employed using state of the art completed for EVO-xx-
1 1 IIA Yes No N/A
Impact approaches which address the cause of yy-zz-D and EVO-xx-yy-
Harm requiring medical failure/failure mode. Such solutions relate to zz-C devices per ref:
intervention, within the same features/ geometry/ materials which provide a VAL07-0028 REPORT
operating procedure. No further high degree of assurance of robust designs Rev 2
hospital stay required established effective through clinical use.
Implementation
Incorrect geometry. Risk Control History shows 0 failure
wire weave cross- (s) out of 14724 devices
sectional area . Stent geometry and dimensions are specified by used in patients over a 3
Outer diameter of design. They are designed to offer an adequate year (03 Jul 2014 to 03
the woven stent is level of radial force for this design Jul 2017) period.
too large.
3 Likely IIB
Design solutions employed using state of the art Radial Force Testing of
approaches which address the cause of the Stent has been
1 1 IIA Yes No N/A
failure/failure mode. Such solutions relate to completed for EVO-xx-
features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
high degree of assurance of robust designs zz-C devices per ref:
established effective through clinical use. VAL07-0028 REPORT
Rev 2
Implementation
Wire diameter, Risk Control History shows 0 failure
weave pattern and Wire diameter, weave pattern and number of (s) out of 14724 devices
number of crowns crowns are specified by design. used in patients over a 3
are incorrect year (03 Jul 2014 to 03
failure/failure mode. Such solutions relate to Radial Force Testing of
1 1 IIA Yes No N/A
features/ geometry/ materials which provide a the Stent has been
Situation Incorrect material Risk Control History shows 0 failure
Stent collapses in tract. Tract selection. Stent (s) out of 14724 devices
becomes occluded material is not self- Stent material is Nitinol as specified by design. used in patients over a 3
expanding, not Nitinol is superelastic and self expanding. It offers year (03 Jul 2014 to 03
Harm superelastic, not adequate stiffness for this application. AF Jul 2017) period.
Reocclusion occurs, requiring stiff enough, Af temperature selected is suitable for this
secondary intervention temperature is too application Radial Force Testing of
high. the Stent has been
Impact 4 Likely I Design solutions employed using state of the art 1 completed for EVO-xx- 1 IIA Yes No N/A
Harm requiring secondary approaches which address the cause of yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged failure/failure mode. Such solutions relate to zz-C devices per ref:
hospitalisation required features/ geometry/ materials which provide a VAL07-0028 REPORT
high degree of assurance of robust designs Rev 2
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
wire weave cross- (s) out of 14724 devices
sectional area . Stent geometry and dimensions are specified by used in patients over a 3
Outer diameter of design. They are designed to offer an adequate year (03 Jul 2014 to 03
the woven stent is level of radial force for this design Jul 2017) period.
too large.
1 1 IIA Yes No N/A
Rev 2
Implementation
1 1 IIA Yes No N/A
17.5.2. Exerts too much radial force Situation Incorrect material Risk Control History shows 0 failure
Stent excessively expands tract selection. Stent Stent material Nitinol as specified by design. (s) out of 14724 devices
material is Nitinol material is self-expanding and used in patients over a 3
Harm excessively self- superelastic. It has a single woven wire design year (03 Jul 2014 to 03
Perforation and/or minor bleed expanding beyond which maintains fully expanded stent diameter Jul 2017) period.
(self-limited) specified diameter
Impact approaches which address the cause of the Stent has been
1 1 IIA Yes No N/A
Harm requiring medical failure/failure mode. Such solutions relate to completed for EVO-xx-
intervention, within the same features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
operating procedure. No further high degree of assurance of robust designs zz-C devices per ref:
hospital stay required established effective through clinical use. VAL07-0028 REPORT
Rev 2
Implementation
wire weave cross- Stent geometry and dimensions are specified by (s) out of 14724 devices
sectional area. design. They are designed to offer an adequate used in patients over a 3
3 Likely IIB Outer diameter of level of radial force for this design year (03 Jul 2014 to 03
the woven stent is Jul 2017) period.
too large. Design solutions employed using state of the art
approaches which address the cause of Radial Force Testing of
failure/failure mode. Such solutions relate to 1 the Stent has been 1 IIA Yes No N/A
VAL07-0028 REPORT
Design solutions employed using state of the art 1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Perforation (medical intervention expanding beyond which maintains fully expanded stent diameter Jul 2017) period.
required) and/or major bleed specified diameter
(transfusion required) Design solutions employed using state of the art Radial Force Testing of
1 1 IIA Yes No N/A
Impact failure/failure mode. Such solutions relate to completed for EVO-xx-
Harm requiring secondary features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged high degree of assurance of robust designs zz-C devices per ref:
hospitalisation required established effective through clinical use. VAL07-0028 REPORT
Rev 2
Implementation
sectional area. design. They are designed to offer an adequate used in patients over a 3
Outer diameter of level of radial force for this design year (03 Jul 2014 to 03
4 Unlikely IIB approaches which address the cause of Radial Force Testing of
VAL07-0028 REPORT
1 1 IIA Yes No N/A
Minor trauma to mucosa expanding beyond which maintains fully expanded stent diameter Jul 2017) period.
specified diameter
Impact Design solutions employed using state of the art Radial Force Testing of
Temporary discomfort- medical approaches which address the cause of the Stent has been
1 1 IIA Yes No N/A
intervention not required failure/failure mode. Such solutions relate to completed for EVO-xx-
2 Likely IIA high degree of assurance of robust designs zz-C devices per ref:
Rev 2
Implementation
sectional area. design. They are designed to offer an adequate 1 used in patients over a 3 1 IIA Yes No N/A
Outer diameter of level of radial force for this design year (03 Jul 2014 to 03
Min
Has risk
Probability Is a
of Risk ?
?
Control
failure/failure mode. Such solutions relate to the Stent has been
VAL07-0028 REPORT
1 1 IIA Yes No N/A
17.6. Resist 17.6.1. Does not resist migration Situation Incorrect material Risk Control History shows 0 failure
migration Stent migrates from it's deployed selection resulting Stent material is Nitinol as specified by design. (s) out of 14724 devices
position in the GI tract. in the stent failing Nitinol is superelastic and self expanding. AF used in patients over a 3
to open up fully temperature selected is suitable for this year (03 Jul 2014 to 03
Harm following application. This material allows for full expansion Jul 2017) period.
Reocclusion occurs, requiring deployment upon deployment
secondary intervention (Material is not Radial Force Testing of
self-expanding, not Design solutions employed using state of the art the Stent has been
Impact superelastic, not approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Harm requiring secondary stiff enough, Af failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged temperature is too features/ geometry/ materials which provide a zz-C devices per ref:
hospitalisation required high) high degree of assurance of robust designs VAL07-0028 REPORT
established effective through clinical use. Rev 2
Implementation
resulting in Stent geometry and dimensions are specified by (s) out of 14724 devices
inadequate radial design. They are designed to offer an adequate used in patients over a 3
force. Outer level of radial force for this application ensuring year (03 Jul 2014 to 03
diameter of the the stent expands fully Jul 2017) period.
woven stent is too
4 Likely I small) Design solutions employed using state of the art
1 1 IIA Yes No N/A
VAL07-0028 REPORT
DWG0288 'Enteral Stent ' Simulated Use Testing
DWG0289 'Colonic Stent' has been completed for
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
number of crowns crowns are specified by design. 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
single woven wire single woven wire designs and the gaps between (s) out of 14724 devices
design & gaps wire weaves are specified by design. These allow used in patients over a 3
between wire the stent to adequately embed itself in the year (03 Jul 2014 to 03
weaves do not stricture wall following expansion Jul 2017) period.
allow the stent to
embed itself in the Design solutions employed using state of the art Radial Force Testing of
stricture wall approaches which address the cause of the Stent has been
1 1 IIA Yes No N/A
following failure/failure mode. Such solutions relate to completed for EVO-xx-
expansion. features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
Rev 2
Implementation
woven stent is too
small) Design solutions employed using state of the art Radial Force Testing of
1 1 IIA Yes No N/A
Rev 2
Implementation
Stent migrates from it's deployed selection resulting Stent material is Nitinol as specified by design. (s) out of 14724 devices
position in the GI tract. in the stent failing Nitinol is superelastic and self expanding. AF used in patients over a 3
to open up fully temperature selected is suitable for this year (03 Jul 2014 to 03
Harm following application. This material allows for full expansion Jul 2017) period.
Perforation (medical intervention deployment upon deployment
required) and/or major bleed (Material is not Radial Force Testing of
(transfusion required) self-expanding, not Design solutions employed using state of the art the Stent has been
superelastic, not approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Impact stiff enough, Af failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Harm requiring secondary temperature is too features/ geometry/ materials which provide a zz-C devices per ref:
intervention and/ or prolonged high) high degree of assurance of robust designs VAL07-0028 REPORT
hospitalisation required established effective through clinical use. Rev 2
Implementation
4 Unlikely IIB DWG0288 'Enteral Stent '
woven stent is too
small) Design solutions employed using state of the art 1 1 IIA Yes No N/A
VAL07-0028 REPORT
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
1 1 IIA Yes No N/A
allow the stent to
1 1 IIA Yes No N/A
Rev 2
Implementation
woven stent is too
1 1 IIA Yes No N/A
Rev 2
Implementation
Stent migrates immediately from selection resulting Stent material is Nitinol as specified by design. (s) out of 14724 devices
it's deployed position in the GI in the stent failing Nitinol is superelastic and self expanding. AF used in patients over a 3
tract. Replacement device to open up fully temperature selected is suitable for this year (03 Jul 2014 to 03
required following application. This material allows for full expansion Jul 2017) period.
deployment upon deployment
Harm (Material is not Radial Force Testing of
Additional exposure to sedation, 2 Likely IIA self-expanding, not Design solutions employed using state of the art 1 the Stent has been 1 IIA Yes No N/A
radiation and/or contrast superelastic, not approaches which address the cause of completed for EVO-xx-
stiff enough, Af failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Impact temperature is too features/ geometry/ materials which provide a zz-C devices per ref:
Temporary discomfort- medical high) high degree of assurance of robust designs VAL07-0028 REPORT
intervention not required established effective through clinical use. Rev 2
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
woven stent is too
small) Design solutions employed using state of the art
1 1 IIA Yes No N/A
VAL07-0028 REPORT
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
1 1 IIA Yes No N/A
allow the stent to
1 1 IIA Yes No N/A
Rev 2
Implementation
woven stent is too
approaches which address the cause of 1 the Stent has been 1 IIA Yes No N/A
Rev 2
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
17.7. Establish 17.7.1. Does not establish patency of Situation Incorrect material Risk Control History shows 0 failure
and the stricture wall Stent does not expand fully at selection. Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
Maintain deployment and patency is not material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
patency restored. Lesion goes untreated. expanding, not adequate stiffness for this application. AF year (03 Jul 2014 to 03
of the superelastic, not temperature selected is suitable for this Jul 2017) period.
stricture Harm stiff enough, Af application
wall Continuation of occlusion (which temperature is too
can be treated within the same high. Design solutions employed using state of the art Simulated Use Testing:
procedure) approaches which address the cause of Deployment Testing [in a
Impact features/ geometry/ materials which provide a completed for EVO-xx-
Harm requiring medical high degree of assurance of robust designs yy-zz-D and EVO-xx-yy-
intervention, within the same established effective through clinical use. zz-C devices per ref:
operating procedure. No further VAL08-0011 REPORT
hospital stay required Implementation Rev 1
1 1 IIA Yes No N/A
C product(s) tested
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
Radial Force Testing of
the Stent has been
VAL07-0028 REPORT
Rev 2
3 Likely IIB
Outer diameter of Stent geometry and dimensions are specified by (s) out of 14724 devices
the woven the stent design. They are designed to offer an adequate used in patients over a 3
is too small. level of radial force for this application year (03 Jul 2014 to 03
Jul 2017) period.
EVO-xx-yy-zz-D
1 design to EVO-xx-yy-zz- 1 IIA Yes No N/A
C product(s) tested
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Min
Has risk
Probability Is a
of Risk ?
?
Control
Rev 2
1 1 IIA Yes No N/A
Stent does not expand fully at selection. Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
deployment and patency is not material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
restored. Stent migration. expanding, not adequate stiffness for this application. AF year (03 Jul 2014 to 03
superelastic, not temperature selected is suitable for this Jul 2017) period.
Harm stiff enough, Af application
Foreign body / matter left in temperature is too
patient which can be retrieved high. Design solutions employed using state of the art Simulated Use Testing:
within the same procedure. approaches which address the cause of Deployment Testing [in a
Impact features/ geometry/ materials which provide a completed for EVO-xx-
Harm requiring medical high degree of assurance of robust designs yy-zz-D and EVO-xx-yy-
intervention, within the same established effective through clinical use. zz-C devices per ref:
operating procedure. No further VAL08-0011 REPORT
hospital stay required Implementation Rev 1
1 1 IIA Yes No N/A
C product(s) tested
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
3 Likely IIB Radial Force Testing of
the Stent has been
VAL07-0028 REPORT
Rev 2
is too small. level of radial force for this application year (03 Jul 2014 to 03
Jul 2017) period.
established effective through clinical use. 1 completed for EVO-xx- 1 IIA Yes No N/A
EVO-xx-yy-zz-D
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Rev 2
1 1 IIA Yes No N/A
Stent does not expand fully at selection. Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
deployment and patency is not material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
restored. GI tract is occluded. expanding, not adequate stiffness for this application. AF year (03 Jul 2014 to 03
superelastic, not temperature selected is suitable for this Jul 2017) period.
Harm stiff enough, Af application
Reocclusion occurs, requiring temperature is too
secondary intervention high. Design solutions employed using state of the art Simulated Use Testing:
Impact failure/failure mode. Such solutions relate to clinical setting] has been
Harm requiring secondary features/ geometry/ materials which provide a completed for EVO-xx-
intervention and/ or prolonged high degree of assurance of robust designs yy-zz-D and EVO-xx-yy-
hospitalisation required established effective through clinical use. zz-C devices per ref:
VAL08-0011 REPORT
1 1 IIA Yes No N/A
C product(s) tested
EVO-xx-yy-zz-D and
4 Likely I EVO-xx-yy-zz-C devices
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Rev 2
is too small. level of radial force for this application 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D
C product(s) tested
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Rev 2
1 1 IIA Yes No N/A
17.7.2. Does not maintain patency of Situation Incorrect design - Risk Control History shows 1 failure
the GI Tract Late stent occlusion occurs. GI stent has Stent does not have sharp edges as specified by (s) out of 14724 devices
tract is occluded. sharp/rough edges design used in patients over a 3
year (03 Jul 2014 to 03
Harm Design solutions employed using state of the art Jul 2017) period.
Continuation of occlusion (which approaches which address the cause of Occurrence < 0.04%
can be treated within the same failure/failure mode. Such solutions relate to
1 1 IIA Yes No N/A
procedure) features/ geometry/ materials which provide a
3 Likely IIB Incorrect surface Risk Control History shows 1 failure
finish: Stent does not have rough edges as specified by (s) out of 14724 devices
Stent surface is too design used in patients over a 3
rough/surface year (03 Jul 2014 to 03
defects are Design solutions employed using state of the art Jul 2017) period.
present. approaches which address the cause of Occurrence < 0.04%
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
17.8. Be 17.8.1. Stent has sharp or rough edges Situation Incorrect design - Risk Control History shows 0 failure
atraumat Stent rubs against GI tract. (Stent stent design has Stent has no sharp edges as specified by design (s) out of 14724 devices
ic does not penetrate GI tract wall) sharp edges used in patients over a 3
Design solutions employed using state of the art year (03 Jul 2014 to 03
Harm approaches which address the cause of Jul 2017) period.
Minor trauma to mucosa failure/failure mode. Such solutions relate to
Implementation
2 Likely IIA
Incorrect surface Risk Control History shows 0 failure
finish. Surface is Stent has no sharp edges as specified by design (s) out of 14724 devices
too rough. Surface used in patients over a 3
defects are Design solutions employed using state of the art year (03 Jul 2014 to 03
present. approaches which address the cause of Jul 2017) period.
Implementation
Traumatic stent rubs against GI stent design has Stent has no sharp edges as specified by design (s) out of 14724 devices
tract. (Stent injury GI tract wall) sharp edges used in patients over a 3
Perforation (medical intervention failure/failure mode. Such solutions relate to
required) and/or major bleed features/ geometry/ materials which provide a 1 1 IIA Yes No N/A
(transfusion required) high degree of assurance of robust designs
Impact
intervention and/ or prolonged DWG0288 'Enteral Stent '
hospitalisation required DWG0289 'Colonic Stent'
4 Unlikely IIB
Implementation
tract. (Stent injury GI tract wall) sharp edges used in patients over a 3
Perforation and/or minor bleed failure/failure mode. Such solutions relate to
(self-limited) features/ geometry/ materials which provide a 1 1 IIA Yes No N/A
Harm requiring medical 3 Likely IIB
defects are Design solutions employed using state of the art 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
tract. Late stent occlusion occurs sharp edges used in patients over a 3
Continuation of occlusion (which failure/failure mode. Such solutions relate to
can be treated within the same features/ geometry/ materials which provide a 1 1 IIA Yes No N/A
Impact
hospital stay required 3 Likely IIB
Implementation
17.9. Expand 17.9.1. Does not expand uniformly upon Situation (Duodenal prodct Risk Control History shows 2 failure
uniformly deployment Stent does not expand fully at only) Stent wire weave design ensures there is a (s) out of 8580 devices
upon deployment. Incorrect design - uniform distribution of radial force used in patients over a 3
deploym GI tract patency is not restored single woven wire circumferentially and longitudinally as specified by year (03 Jul 2014 to 03
1 1 IIA Yes No N/A
ent uniformly along the full stent design is non- design Jul 2017) period.
length. Lesion is untreated. uniform throughout Occurrence < 0.04%
the stent. Implementation
Harm DWG0288 'Enteral Stent '
can be treated within the same (Colonic prodct Risk Control History shows 0 failure
procedure) only) Stent wire weave design ensures there is a (s) out of 6144 devices
Incorrect design - uniform distribution of radial force used in patients over a 3
Impact single woven wire circumferentially and longitudinally as specified by year (03 Jul 2014 to 03
Harm requiring medical design is non- design Jul 2017) period.
intervention, within the same uniform throughout
operating procedure. No further the stent. Design solutions employed using state of the art
hospital stay required approaches which address the cause of 1 1 IIA Yes No N/A
3 Likely IIB established effective through clinical use.
Implementation
(Colonic prodct Risk Control History shows 0 failure
only) The Stent is woven from a Nitinol wire. The stent (s) out of 6144 devices
Incorrect design - design as specified by design ensures that the used in patients over a 3
Stent is not stent has a circular outer profile following year (03 Jul 2014 to 03
designed to have a expansion Jul 2017) period.
circular outer
profile following Design solutions employed using state of the art
expansion and it approaches which address the cause of 1 1 IIA Yes No N/A
does not match the failure/failure mode. Such solutions relate to
geometry of the GI features/ geometry/ materials which provide a
inner lumen. high degree of assurance of robust designs
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
(Duodenal prodct Risk Control History shows 2 failure
circular outer 1 Occurrence < 0.04% 1 IIA Yes No N/A
profile following Implementation
expansion and it DWG0288 'Enteral Stent '
does not match the
geometry of the GI
inner lumen.
Situation (Colonic prodct Risk Control History shows 0 failure
Stent does not expand fully at only) Stent wire weave design ensures there is a (s) out of 6144 devices
deployment. Incorrect design - uniform distribution of radial force used in patients over a 3
GI tract patency is not restored single woven wire circumferentially and longitudinally as specified by year (03 Jul 2014 to 03
uniformly along the full stent design is non- design Jul 2017) period.
length. GI tract occluded. uniform throughout
the stent. Design solutions employed using state of the art
Harm approaches which address the cause of 1 1 IIA Yes No N/A
Reocclusion occurs, requiring failure/failure mode. Such solutions relate to
secondary intervention features/ geometry/ materials which provide a
intervention and/ or prolonged Implementation
hospitalisation required DWG0289 'Colonic Stent'
only) Stent wire weave design ensures there is a (s) out of 8580 devices
Incorrect design - uniform distribution of radial force used in patients over a 3
single woven wire circumferentially and longitudinally as specified by year (03 Jul 2014 to 03
1 1 IIA Yes No N/A
design is non- design Jul 2017) period.
uniform throughout Occurrence < 0.04%
the stent. Implementation
(Colonic prodct Risk Control History shows 0 failure
4 Likely I only) The Stent is woven from a Nitinol wire. The stent (s) out of 6144 devices
circular outer
profile following Design solutions employed using state of the art
expansion and it approaches which address the cause of 1 1 IIA Yes No N/A
does not match the failure/failure mode. Such solutions relate to
geometry of the GI features/ geometry/ materials which provide a
inner lumen. high degree of assurance of robust designs
Implementation
circular outer 1 Occurrence < 0.04% 1 IIA Yes No N/A
profile following Implementation
expansion and it DWG0288 'Enteral Stent '
does not match the
geometry of the GI
inner lumen.
17.10. Shaped 17.10.1. Is not shaped to match the Situation Incorrect material Risk Control History shows 0 failure
to geometry of the GI tract inner Outer profile of stent does not selected - Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
match lumen appose GI tract wall. material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
the expanding, not adequate stiffness for this application. year (03 Jul 2014 to 03
geomet Harm superelastic, not Jul 2017) period.
ry of the Reocclusion occurs, requiring 4 Likely I stiff enough. Design solutions employed using state of the art 1 1 IIA Yes No N/A
patient secondary intervention approaches which address the cause of
anatom failure/failure mode. Such solutions relate to Simulated Use Testing
y. Impact features/ geometry/ materials which provide a has been completed for
Harm requiring secondary high degree of assurance of robust designs EVO-xx-yy-zz-D and
intervention and/ or prolonged established effective through clinical use. EVO-xx-yy-zz-C devices
Min
Has risk
Probability Is a
of Risk ?
?
Control
hospitalisation required per ref: VAL07-0016
Implementation REPORT Rev 1
DWG0288 'Enteral Stent ' EVO-xx-yy-zz-C & EVO-
DWG0289 'Colonic Stent' xx-yy-zz-D products are
tested
Stent is not The Stent is woven from a Nitinol wire. The stent (s) out of 14724 devices
designed to have a design as specified by design ensures that the used in patients over a 3
circular outer stent has a circular outer profile following year (03 Jul 2014 to 03
profile following expansion Jul 2017) period.
expansion and it
does not match the Design solutions employed using state of the art
geometry of the GI approaches which address the cause of
1 1 IIA Yes No N/A
tract. failure/failure mode. Such solutions relate to
Implementation
17.11. Withsta 17.11.1. Does not withstand Situation Incorrect material Risk Control History shows 0 failure
nd compressive forces during Stent is compressed during selected - Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
compre deployment deployment. Section of deployed material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
ssive stent is distorted causing expanding, not adequate stiffness for this application. year (03 Jul 2014 to 03
forces occlusion. superelastic, not Jul 2017) period.
during stiff enough. Design solutions employed using state of the art
deploy Harm approaches which address the cause of
ment Continuation of occlusion (which failure/failure mode. Such solutions relate to Simulated Use Testing
can be treated within the same features/ geometry/ materials which provide a 1 has been completed for 1 IIA Yes No N/A
procedure) high degree of assurance of robust designs EVO-xx-yy-zz-D and
Impact per ref: NCT16-0036-R
Harm requiring medical Implementation Ver 0
intervention, within the same DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
operating procedure. No further DWG0289 'Colonic Stent' products are of similar
hospital stay required design to EVO-xx-yy-zz-
C product(s) tested
3 Likely IIB
the woven the stent design. They are designed to withstand used in patients over a 3
is too big. compressive forces. year (03 Jul 2014 to 03
Jul 2017) period.
C product(s) tested
Stent is compressed during selected - Stent Stent material is Nitinol as specified by design. (s) out of 14724 devices
deployment. Section of deployed material is not self- Nitinol is superelastic and self expanding. It offers used in patients over a 3
stent is distorted causing expanding, not adequate stiffness for this application. year (03 Jul 2014 to 03
occlusion. superelastic, not Jul 2017) period.
stiff enough. Design solutions employed using state of the art
Reocclusion occurs, requiring 4 Likely I failure/failure mode. Such solutions relate to 1 Simulated Use Testing 1 IIA Yes No N/A
secondary intervention features/ geometry/ materials which provide a has been completed for
Harm requiring secondary per ref: NCT16-0036-R
intervention and/ or prolonged Implementation Ver 0
hospitalisation required DWG0288 'Enteral Stent ' EVO-xx-yy-zz-D
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
the woven the stent design. They are designed to withstand used in patients over a 3
is too big. compressive forces. year (03 Jul 2014 to 03
Jul 2017) period.
C product(s) tested
17.12. Compre 17.12.1. Compression and Expansive Situation Incorrect material Risk Control History shows 0 failure
ssion forces are not of adequate Compression and Expansive selection. Stent (s) out of 14724 devices
and force to maintain patency of forces are inadequate for material is not self- Stent material is Nitinol as specified by design. used in patients over a 3
Expansi malignant Colonic/Duodenal intended use expanding/compres Nitinol material is self expanding/compressive and year (03 Jul 2014 to 03
ve strictures sive not superelastic. It offers adequate amount of Jul 2017) period.
forces Harm superelastic, not stiffness for this application
must be Reocclusion occurs, requiring stiff enough Radial Force Testing of
of secondary intervention Design solutions employed using state of the art the Stent has been
adequat approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
e force Impact failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
to Harm requiring secondary features/ geometry/ materials which provide a zz-C devices per ref:
maintai intervention and/ or prolonged high degree of assurance of robust designs VAL07-0028 REPORT
n hospitalisation required established effective through clinical use. Rev 2
patency
of Implementation
maligna DWG0288 'Enteral Stent '
nt 4 Likely I DWG0289 'Colonic Stent'
stricture
s Incorrect geometry. Risk Control History shows 0 failure
the woven stent is design. They are designed to offer an adequate used in patients over a 3
too small level of radial force for this application year (03 Jul 2014 to 03
Jul 2017) period.
VAL07-0028 REPORT
Excessive radial force exerted by selection. Stent (s) out of 14724 devices
the stent when implanted material is not self- Stent material is Nitinol as specified by design. used in patients over a 3
expanding/compres Nitinol material is self expanding/compressive and year (03 Jul 2014 to 03
Harm sive not superelastic. It offers adequate amount of Jul 2017) period.
Irritation / edema/ ulceration at superelastic, not stiffness for this application
mucosa requiring medical stiff enough Radial Force Testing of
intervention (such as Design solutions employed using state of the art the Stent has been
medications) approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
2 Likely IIA failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Impact features/ geometry/ materials which provide a zz-C devices per ref:
Temporary discomfort- medical high degree of assurance of robust designs VAL07-0028 REPORT
intervention not required established effective through clinical use. Rev 2
Implementation
Outer diameter of Stent geometry and dimensions are specified by 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Jul 2017) period.
VAL07-0028 REPORT
Migration of stent due to selection. Stent (s) out of 14724 devices
insufficient radial forces material is not self- Stent material is Nitinol as specified by design. used in patients over a 3
Continuation of occlusion (which superelastic, not stiffness for this application
can be treated within the same stiff enough Radial Force Testing of
procedure) Design solutions employed using state of the art the Stent has been
approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Impact failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Harm requiring medical features/ geometry/ materials which provide a zz-C devices per ref:
intervention, within the same high degree of assurance of robust designs VAL07-0028 REPORT
operating procedure. No further established effective through clinical use. Rev 2
Implementation
3 Likely IIB DWG0289 'Colonic Stent'
Jul 2017) period.
VAL07-0028 REPORT
Foreign body / matter left in superelastic, not stiffness for this application
patient which requires secondary stiff enough Radial Force Testing of
intervention. Design solutions employed using state of the art the Stent has been
approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Impact failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Harm requiring secondary features/ geometry/ materials which provide a zz-C devices per ref:
intervention and/ or prolonged high degree of assurance of robust designs VAL07-0028 REPORT
hospitalisation required established effective through clinical use. Rev 2
4 Unlikely IIB
Implementation
1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL07-0028 REPORT
Reocclusion occurs, requiring superelastic, not stiffness for this application
secondary intervention stiff enough Radial Force Testing of
Design solutions employed using state of the art the Stent has been
Impact approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Harm requiring secondary failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged features/ geometry/ materials which provide a zz-C devices per ref:
hospitalisation required high degree of assurance of robust designs VAL07-0028 REPORT
Implementation
4 Likely I DWG0289 'Colonic Stent'
Jul 2017) period.
VAL07-0028 REPORT
17.13. Radial 17.13.1. Insufficient radial forces to Situation Incorrect material Risk Control History shows 0 failure
forces minimise stent migration Stent migrates leading to selection resulting Stent material is Nitinol as specified by design. (s) out of 14724 devices
must be reocclusion. in the stent failing Nitinol material is self-expanding and used in patients over a 3
sufficie to open up fully superelastic. AF temperature selected is suitable year (03 Jul 2014 to 03
nt to Harm following for this application. The material allows the stent Jul 2017) period.
minimis Reocclusion occurs, requiring deployment to expand fully following deployment
e stent secondary intervention (Material is not self Radial Force Testing of
migratio expanding, not Design solutions employed using state of the art the Stent has been
n Impact superelastic, not approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Harm requiring secondary stiff enough. AF failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged temperature is too features/ geometry/ materials which provide a zz-C devices per ref:
hospitalisation required high) high degree of assurance of robust designs VAL07-0028 REPORT
Implementation
4 Likely I
woven stent is too
small Design solutions employed using state of the art
Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Rev 2
Stent migrates leading to selection resulting Stent material is Nitinol as specified by design. (s) out of 14724 devices
reocclusion. in the stent failing Nitinol material is self-expanding and used in patients over a 3
to open up fully superelastic. AF temperature selected is suitable year (03 Jul 2014 to 03
Harm following for this application. The material allows the stent Jul 2017) period.
Continuation of occlusion (which deployment to expand fully following deployment
can be treated within the same (Material is not self Radial Force Testing of
procedure) expanding, not Design solutions employed using state of the art the Stent has been
superelastic, not approaches which address the cause of 1 completed for EVO-xx- 1 IIA Yes No N/A
Impact stiff enough. AF failure/failure mode. Such solutions relate to yy-zz-D and EVO-xx-yy-
Harm requiring medical temperature is too features/ geometry/ materials which provide a zz-C devices per ref:
intervention, within the same high) high degree of assurance of robust designs VAL07-0028 REPORT
operating procedure. No further established effective through clinical use. Rev 2
Implementation
3 Likely IIB force. Outer level of radial force for this application ensuring year (03 Jul 2014 to 03
woven stent is too
small Design solutions employed using state of the art
1 1 IIA Yes No N/A
Ver 0
C product(s) tested
the Stent has been
VAL07-0028 REPORT
Rev 2
17.14. Stent 17.14.1. Stent material characteristics Situation Incorrect material Risk Control History shows 0 failure
material are not suitable for the Stent material fatigues and selection. Stent Stent material is Nitinol as specified by design, (s) out of 14724 devices
charact requirements of the indicated becomes frayed. Punctures GI material does not which comprises of Nickel and Titanium mix , used in patients over a 3
eristics area of implantation tract. match which is adequate to fit body environment. year (03 Jul 2014 to 03
must be characteristics Jul 2017) period.
suitable Harm needed within the Design solutions employed using state of the art
for the Perforation and/or minor bleed body environment approaches which address the cause of
require (self-limited) failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
ments features/ geometry/ materials which provide a
of the Impact high degree of assurance of robust designs
indicate Harm requiring medical established effective through clinical use.
d area intervention, within the same 3 Likely IIB
of operating procedure. No further Implementation
implant hospital stay required DWG0288 'Enteral Stent '
ation DWG0289 'Colonic Stent'
Incorrect stent Risk Control History shows 0 failure
surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
have a smooth 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Incorrect geometry: Risk Control History shows 0 failure
Outer diameter of (s) out of 14724 devices
the woven stent is Stent geometry is specified by design, and is used in patients over a 3
too small designed to offer an adequate level of radial force year (03 Jul 2014 to 03
for it's application Jul 2017) period.
approaches which address the cause of [in a clinical setting] has
1 1 IIA Yes No N/A
failure/failure mode. Such solutions relate to been completed for
REPORT Rev 1
Implementation
wire diameter of (s) out of 14724 devices
the woven stent is Stent wire diameter geometry is specified by used in patients over a 3
too large design, and is designed to offer an adequate level year (03 Jul 2014 to 03
of stiffness for this application. Jul 2017) period.

1 1 IIA Yes No N/A
Implementation
Stent material is Stent material is Nitinol as specified by design. (s) out of 14724 devices
too stiff Nitinol offers elastic material properties which used in patients over a 3
provides adequate stiffness for this application year (03 Jul 2014 to 03
Jul 2017) period.
Implementation
Material properties Stent material is Nitinol as specified by design. (s) out of 14724 devices
adversely change Nitinol material is self-expanding and used in patients over a 3
due to operation at superelastic. It does not adversely change due to year (03 Jul 2014 to 03
failure/failure mode. Such solutions relate to 1 clinical setting] has been 1 IIA Yes No N/A
VAL08-0011 REPORT
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Stent material fatigues and selection. Stent Stent material is Nitinol as specified by design, (s) out of 14724 devices
becomes frayed. Punctures GI material does not which comprises of Nickel and Titanium mix , used in patients over a 3
tract. match which is adequate to fit body environment. year (03 Jul 2014 to 03
characteristics Jul 2017) period.
Harm needed within the Design solutions employed using state of the art
Perforation (medical intervention body environment approaches which address the cause of
required) and/or major bleed failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
(transfusion required) features/ geometry/ materials which provide a
intervention and/ or prolonged Implementation
hospitalisation required DWG0288 'Enteral Stent '
have a smooth year (03 Jul 2014 to 03
1 1 IIA Yes No N/A
Implementation
4 Unlikely IIB the woven stent is Stent geometry is specified by design, and is used in patients over a 3
1 1 IIA Yes No N/A
REPORT Rev 1
Implementation

1 1 IIA Yes No N/A
Implementation
Stent material is Stent material is Nitinol as specified by design. 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Jul 2017) period.
Implementation
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Stent material fatigues and selection. Stent Stent material is Nitinol as specified by design, (s) out of 14724 devices
Reocclusion occurs, requiring body environment approaches which address the cause of
secondary intervention failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
Harm requiring secondary established effective through clinical use.
hospitalisation required Implementation
4 Unlikely IIB surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
1 1 IIA Yes No N/A
Implementation
the woven stent is Stent geometry is specified by design, and is 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT Rev 1
Implementation

1 1 IIA Yes No N/A
Implementation
Jul 2017) period.
Implementation
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
Stent material fatigues and 2 Likely IIA selection. Stent Stent material is Nitinol as specified by design, 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Minor trauma to mucosa body environment approaches which address the cause of
Temporary discomfort- medical high degree of assurance of robust designs
intervention not required established effective through clinical use.
Implementation
1 1 IIA Yes No N/A
Implementation
the woven stent is Stent geometry is specified by design, and is used in patients over a 3
1 1 IIA Yes No N/A
REPORT Rev 1
Implementation

1 1 IIA Yes No N/A
Implementation
Jul 2017) period.
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0070
REPORT Rev 1
17.15. Diamet 17.15.1. Diameter and length are not Situation Incorrect design - Risk Control History shows 0 failure
er and appropriate for the intended Stent migrates leading to stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
length use post-expansion. reocclusion. wire design does adequate level of wall apposition used in patients over a 3
must be not ensure all of year (03 Jul 2014 to 03
appropr Harm the stent apposes Design solutions employed using state of the art Jul 2017) period.
iate for Continuation of occlusion (which GI tract following approaches which address the cause of
intende can be treated within the same expansion failure/failure mode. Such solutions relate to
d use procedure) features/ geometry/ materials which provide a Deployment Accuracy
post- high degree of assurance of robust designs Testing [in a clinical
expansi Impact established effective through clinical use. setting] has been
on Harm requiring medical completed for EVO-xx-
intervention, within the same Implementation yy-zz-D and EVO-xx-yy-
operating procedure. No further DWG0288 'Enteral Stent ' 1 zz-C devices per ref: 1 IIA Yes No N/A
hospital stay required DWG0289 'Colonic Stent' VAL08-0070 REPORT
DWG0497 'TTS SEMS Assembly' Rev 1
EVO-xx-yy-zz-D and
Ver 0
3 Likely IIB EVO-xx-yy-zz-D
C product(s) tested
stent single woven Stent is woven from a nitinol wire. The woven (s) out of 14724 devices
wire design does design ensures that the stent appropriate length used in patients over a 3
not ensure specified on the product after expansion. year (03 Jul 2014 to 03
appropriate length Jul 2017) period.
post-expansion. Design solutions employed using state of the art
C product(s) tested
Stent migrates leading to 4 Likely I stent single woven Stent cell pattern as specified by design assures 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
reocclusion. wire design does adequate level of wall apposition used in patients over a 3
Reocclusion occurs, requiring GI tract following approaches which address the cause of
secondary intervention expansion failure/failure mode. Such solutions relate to
features/ geometry/ materials which provide a Deployment Accuracy
Impact high degree of assurance of robust designs Testing [in a clinical
Harm requiring secondary established effective through clinical use. setting] has been
intervention and/ or prolonged completed for EVO-xx-
hospitalisation required Implementation yy-zz-D and EVO-xx-yy-
DWG0288 'Enteral Stent ' zz-C devices per ref:
DWG0289 'Colonic Stent' VAL08-0070 REPORT
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
Diameter of stent is too large to stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
adequately fit GI tract. Excess wire design does adequate level of wall apposition used in patients over a 3
force applied to stricture wall. not ensure all of year (03 Jul 2014 to 03
the stent apposes Design solutions employed using state of the art Jul 2017) period.
Harm GI tract following approaches which address the cause of
Irritation / edema/ ulceration at expansion failure/failure mode. Such solutions relate to
mucosa requiring medical features/ geometry/ materials which provide a Deployment Accuracy
intervention (such as high degree of assurance of robust designs Testing [in a clinical
medications) established effective through clinical use. setting] has been
Impact Implementation yy-zz-D and EVO-xx-yy-
Harm requiring medical DWG0288 'Enteral Stent ' 1 zz-C devices per ref: 1 IIA Yes No N/A
intervention, within the same DWG0289 'Colonic Stent' VAL08-0070 REPORT
operating procedure. No further DWG0497 'TTS SEMS Assembly' Rev 1
hospital stay required Simulated Use Testing
3 Likely IIB has been completed for
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
not ensure specified on the product after expansion. 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
Diameter of stent is too large to stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
adequately fit GI tract. Excess wire design does adequate level of wall apposition used in patients over a 3
force applied to stricture wall. not ensure all of year (03 Jul 2014 to 03
Perforation (medical intervention expansion failure/failure mode. Such solutions relate to
required) and/or major bleed features/ geometry/ materials which provide a Deployment Accuracy
(transfusion required) high degree of assurance of robust designs Testing [in a clinical
established effective through clinical use. setting] has been
Impact completed for EVO-xx-
Harm requiring secondary Implementation yy-zz-D and EVO-xx-yy-
intervention and/ or prolonged DWG0288 'Enteral Stent ' 1 zz-C devices per ref: 1 IIA Yes No N/A
hospitalisation required DWG0289 'Colonic Stent' VAL08-0070 REPORT
EVO-xx-yy-zz-D and
Ver 0
4 Unlikely IIB EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
(Colonic stent) stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
Stent is too long after deployment wire design does adequate level of wall apposition used in patients over a 3
extends beyond stricture. not ensure all of year (03 Jul 2014 to 03
3 Likely IIB 1 completed for EVO-xx- 1 IIA Yes No N/A
Harm requiring medical DWG0288 'Enteral Stent ' zz-C devices per ref:
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
(Duodenal stent) stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
Stent is too long after deployment wire design does adequate level of wall apposition used in patients over a 3
extends beyond stricture. not ensure all of year (03 Jul 2014 to 03
Harm requiring medical DWG0288 'Enteral Stent ' 1 zz-C devices per ref: 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
Ver 0
3 Likely IIB EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
Stent is too short and does not stent single woven Stent cell pattern as specified by design assures (s) out of 14724 devices
extend beyond stricture. Lesion wire design does adequate level of wall apposition used in patients over a 3
goes untreated. 2 Likely IIA not ensure all of 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Additional exposure to sedation, expansion failure/failure mode. Such solutions relate to
Min
Has risk
Probability Is a
of Risk ?
?
Control
radiation and/or contrast features/ geometry/ materials which provide a Deployment Accuracy
high degree of assurance of robust designs Testing [in a clinical
Impact established effective through clinical use. setting] has been
Temporary discomfort- medical completed for EVO-xx-
intervention not required Implementation yy-zz-D and EVO-xx-yy-
DWG0288 'Enteral Stent ' zz-C devices per ref:
DWG0289 'Colonic Stent' VAL08-0070 REPORT
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
C product(s) tested
17.16. Must 17.16.1. Does not flex with bending or Situation Incorrect material - Risk Control History shows 0 failure
flex with elongate when an longitudinal Stent is rigid Stent material is Stent material is Nitinol as specified by design. (s) out of 14724 devices
bending force is applied to fit in the too stiff Nitinol offers elastic material properties which used in patients over a 3
or patients anatomy Harm provides adequate stiffness for this application year (03 Jul 2014 to 03
elongat Irritation / edema/ ulceration/ Jul 2017) period.
e when erosion at mucosa (health tissue) Design solutions employed using state of the art
a approaches which address the cause of Flexibility Testing [Stent]
longitud Impact failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
inal Temporary discomfort- medical features/ geometry/ materials which provide a EVO-xx-yy-zz-D devices
force is intervention not required high degree of assurance of robust designs per ref: VAL12-0051
applied established effective through clinical use. REPORT Rev 1
to fit in
the Implementation
patients DWG0288 'Enteral Stent '
anatom DWG0289 'Colonic Stent'
y
- cross-section Stent wire weave cross-sectional area as (s) out of 14724 devices
area of stent wire specified by design provides an adequate level of used in patients over a 3
2 Likely IIA weave is too large flexibility for this application year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of Flexibility Testing [Stent]
Implementation
Diameter of the Wire woven stent as specified by design has (s) out of 14724 devices
woven stent is too adequate diameter to provide correct level of used in patients over a 3
small/big and does flexibility for this application 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
not ensure an Jul 2017) period.
adequate level of Design solutions employed using state of the art
Min
Has risk
Probability Is a
of Risk ?
?
Control
flexibility approaches which address the cause of Flexibility Testing [Stent]
Implementation

1 1 IIA Yes No N/A
Implementation
Stent is rigid Stent material is Stent material is Nitinol as specified by design. (s) out of 14724 devices
Harm provides adequate stiffness for this application year (03 Jul 2014 to 03
Perforation and/or minor bleed Jul 2017) period.
(self-limited) Design solutions employed using state of the art
Impact failure/failure mode. Such solutions relate to 1 has been completed for 1 IIA Yes No N/A
Harm requiring medical features/ geometry/ materials which provide a EVO-xx-yy-zz-D devices
intervention, within the same high degree of assurance of robust designs per ref: VAL12-0051
operating procedure. No further established effective through clinical use. REPORT Rev 1
Implementation
weave is too large flexibility for this application year (03 Jul 2014 to 03
Jul 2017) period.
3 Likely IIB features/ geometry/ materials which provide a EVO-xx-yy-zz-D devices
Implementation
small/big and does flexibility for this application year (03 Jul 2014 to 03
Implementation
Incorrect material - Risk Control 1 History shows 0 failure 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control

Implementation
Stent is rigid Stent material is Stent material is Nitinol as specified by design. (s) out of 14724 devices
Harm provides adequate stiffness for this application year (03 Jul 2014 to 03
Perforation (medical intervention Jul 2017) period.
required) and/or major bleed Design solutions employed using state of the art
(transfusion required) approaches which address the cause of Flexibility Testing [Stent]
Impact features/ geometry/ materials which provide a EVO-xx-yy-zz-D devices
Harm requiring secondary high degree of assurance of robust designs per ref: VAL12-0051
intervention and/ or prolonged established effective through clinical use. REPORT Rev 1
Implementation
weave is too large flexibility for this application year (03 Jul 2014 to 03
Jul 2017) period.
Implementation
4 Unlikely IIB DWG0288 'Enteral Stent '
small/big and does flexibility for this application year (03 Jul 2014 to 03
Implementation
1 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
17.17. Must 17.17.1. Does Not Remain Intact Situation (Duodenal products Risk Control History shows 1 failure
Remain Stent fracture at deployment - only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
Intact Type I, Single wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fracture only. wire weave Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
penetrates GI tract wall. too stiff Jul 2017) period.
Design solutions employed using state of the art Occurrence < 0.04%
1 1 IIA Yes No N/A
Perforation and/or minor bleed failure/failure mode. Such solutions relate to
(self-limited) features/ geometry/ materials which provide a
(Colonic products Risk Control History shows 0 failure
only) Stent material is Nitinol as specified by design. (s) out of 6144 devices
Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
too stiff Jul 2017) period.
1 1 IIA Yes No N/A
Implementation
3 Likely IIB (Colonic products Risk Control History shows 0 failure

Incorrect material - Nitinol material does not adversely change due to used in patients over a 3
Material properties operation at body temperature year (03 Jul 2014 to 03
adversely change Jul 2017) period.
due to operation at Design solutions employed using state of the art
body temperature approaches which address the cause of
Implementation
(Duodenal products Risk Control History shows 1 failure
due to operation at Design solutions employed using state of the art Occurrence < 0.04%
Implementation
Situation (Colonic products Risk Control History shows 0 failure
Stent fracture at deployment - only) Stent material is Nitinol as specified by design. (s) out of 6144 devices
Type I, Single wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fracture only. wire weaves do not Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
penetrate GI tract wall. 2 Likely IIA too stiff 1 Jul 2017) period. 1 IIA Yes No N/A
Minor trauma to mucosa failure/failure mode. Such solutions relate to
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
1 1 IIA Yes No N/A
Implementation
Implementation
Implementation
Type II, Multiple single wire Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
weave fractures that can occur at Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
different sites. wire weave(s) too stiff Jul 2017) period.
penetrates GI tract wall. Design solutions employed using state of the art
1 1 IIA Yes No N/A
Perforation and/or minor bleed features/ geometry/ materials which provide a
(self-limited) high degree of assurance of robust designs
3 Likely IIB established effective through clinical use.
Impact
intervention, within the same DWG0289 'Colonic Stent'
hospital stay required (Duodenal products Risk Control History shows 1 failure
Stent material is provides adequate stiffness for this application 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Implementation
Implementation
Type III, Multiple wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures resulting in complete Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
transection of the stent, without too stiff Jul 2017) period.
migration of the stent segments. Design solutions employed using state of the art
Wires weave penetrates GI tract approaches which address the cause of
1 1 IIA Yes No N/A
wall. failure/failure mode. Such solutions relate to
Perforation and/or minor bleed established effective through clinical use.
(self-limited)
Implementation
Impact DWG0289 'Colonic Stent'
intervention, within the same (Duodenal products Risk Control History shows 1 failure
operating procedure. No further only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
hospital stay required Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
3 Likely IIB Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
1 1 IIA Yes No N/A
Implementation
Material properties operation at body temperature 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Implementation
Type III, Multiple wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures resulting in complete Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
transection of the stent, without too stiff Jul 2017) period.
migration of the stent segments. Design solutions employed using state of the art
wire weaves do not penetrate GI approaches which address the cause of
1 1 IIA Yes No N/A
tract wall. failure/failure mode. Such solutions relate to
Perforation (medical intervention established effective through clinical use.
required) and/or major bleed
(transfusion required) Implementation
Impact
Harm requiring secondary (Duodenal products Risk Control History shows 1 failure
intervention and/ or prolonged only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
hospitalisation required Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
1 1 IIA Yes No N/A
4 Unlikely IIB high degree of assurance of robust designs
Implementation
Implementation
Incorrect material - Nitinol material does not adversely change due to 1 used in patients over a 3 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Type IV, Multiple wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures resulting in Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
displacement of segments of the too stiff Jul 2017) period.
stent. Type IV includes spiral Design solutions employed using state of the art
fractures that could result in stent approaches which address the cause of
1 1 IIA Yes No N/A
migration without complete failure/failure mode. Such solutions relate to
transection. Surgical intervention features/ geometry/ materials which provide a
required. high degree of assurance of robust designs
Harm
Perforation (medical intervention Implementation
required) and/or major bleed DWG0289 'Colonic Stent'
(transfusion required)
Impact only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
Harm requiring secondary Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
intervention and/ or prolonged Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
hospitalisation required too stiff Jul 2017) period.
1 1 IIA Yes No N/A
Implementation
4 Unlikely IIB (Colonic products Risk Control History shows 0 failure

Implementation
Implementation
Stent fracture at deployment - 4 Unlikely IIB only) Stent material is Nitinol as specified by design. 1 (s) out of 6144 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Type IV, Multiple wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures resulting in Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
displacement of segments of the too stiff Jul 2017) period.
stent. Type IV includes spiral Design solutions employed using state of the art
fractures that could result in stent approaches which address the cause of
migration without complete failure/failure mode. Such solutions relate to
transection. Surgical intervention features/ geometry/ materials which provide a
required. high degree of assurance of robust designs
Harm
Foreign body / matter left in Implementation
patient which requires secondary DWG0289 'Colonic Stent'
intervention.
Impact only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
Harm requiring secondary Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
intervention and/ or prolonged Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
hospitalisation required too stiff Jul 2017) period.
1 1 IIA Yes No N/A
Implementation
Implementation
Implementation
Type I, II, III or IV wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures. wire weave protrudes Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
towards stent lumen impacting on too stiff Jul 2017) period.
flow. Another device required. Design solutions employed using state of the art
1 1 IIA Yes No N/A
Harm 4 Unlikely IIB failure/failure mode. Such solutions relate to
Reocclusion occurs, requiring features/ geometry/ materials which provide a
secondary intervention high degree of assurance of robust designs
Impact
intervention and/ or prolonged DWG0289 'Colonic Stent'
(Duodenal products Risk Control 1 History shows 1 failure 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Implementation
Implementation
Type I, II, III or IV wire weave Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
fractures. wire weave protrudes Stent material is provides adequate stiffness for this application year (03 Jul 2014 to 03
towards stent lumen. Tip gets too stiff Jul 2017) period.
caught on the stent during Design solutions employed using state of the art
remove causing stent damage. approaches which address the cause of
1 1 IIA Yes No N/A
GI tract occluded. failure/failure mode. Such solutions relate to
Foreign body / matter left in established effective through clinical use.
patient which requires secondary
intervention. Implementation
Impact 4 Unlikely IIB
Harm requiring secondary (Duodenal products Risk Control History shows 1 failure
intervention and/ or prolonged only) Stent material is Nitinol as specified by design. (s) out of 8580 devices
hospitalisation required Incorrect material - Nitinol offers elastic material properties which used in patients over a 3
Implementation
Min
Has risk
Probability Is a
of Risk ?
?
Control
Implementation
Implementation
18. Stent 18.1. Be 18.1.1. Marker bands are not visible Situation Incorrect material Risk Control History shows 0 failure
(Marker fluorosco under fluoroscopy Device cannot be used. Device selected - Radiopaque marker material is Tantalum as (s) out of 14724 devices
Bands) pically replaced. radiopaque marker specified by design. Tantalum was selected due used in patients over a 3
visible material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
Harm visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Additional exposure to sedation, fluoroscopy adequately visible under fluoroscopy
radiation and/or contrast Fluoroscopic Visibility
Design solutions employed using state of the art Testing [in a clinical
Impact approaches which address the cause of setting] has been
1 1 IIA Yes No N/A
Temporary discomfort- medical failure/failure mode. Such solutions relate to completed for EVO-xx-
intervention not required features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
Rev 1
C product(s) tested
2 Likely IIA
Incorrect Risk Control History shows 0 failure
dimensions- Radiopaque marker dimensions are specified by (s) out of 14724 devices
radiopaque design. This ensures the marker is appropriately used in patients over a 3
markers are too sized for an adequate level of visibility year (03 Jul 2014 to 03
small to be visible Jul 2017) period.
under fluoroscopy Design solutions employed using state of the art
approaches which address the cause of Fluoroscopic Visibility
failure/failure mode. Such solutions relate to Testing [in a clinical
features/ geometry/ materials which provide a setting] has been
1 1 IIA Yes No N/A
C product(s) tested
Stent deployed in incorrect selected - Radiopaque marker material is Tantalum as (s) out of 14724 devices
location. Lesion goes untreated. 3 Likely IIB radiopaque marker specified by design. Tantalum was selected due 1 used in patients over a 3 1 IIA Yes No N/A
Another stent required to material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
complete the procedure. visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
fluoroscopy adequately visible under fluoroscopy
Fluoroscopic Visibility
Harm Design solutions employed using state of the art Testing [in a clinical
Continuation of occlusion (which approaches which address the cause of setting] has been
can be treated within the same failure/failure mode. Such solutions relate to completed for EVO-xx-
procedure) features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
Impact established effective through clinical use. VAL08-0011 REPORT
Harm requiring medical Rev 1
intervention, within the same Implementation EVO-xx-yy-zz-D
operating procedure. No further DWG0288 'Enteral Stent ' products are of similar
hospital stay required DWG0289 'Colonic Stent' design to EVO-xx-yy-zz-
C product(s) tested
dimensions- Radiopaque marker dimensions are specified by (s) out of 14724 devices
radiopaque design. This ensures the marker is appropriately used in patients over a 3
markers are too sized for an adequate level of visibility year (03 Jul 2014 to 03
small to be visible Jul 2017) period.
under fluoroscopy Design solutions employed using state of the art
1 1 IIA Yes No N/A
C product(s) tested
18.2. Be 18.2.1. Stent markers cause trauma to Situation Incorrect geometry Risk Control History shows 0 failure
atraumat patient tissue Radiopaque markers rub against - radiopaque Radiopaque marker has appropriate surface with (s) out of 14724 devices
ic stricture wall marker has a rough no sharp edges and covered by a layer of used in patients over a 3
surface with sharp protective silicone to ensure the joint has an year (03 Jul 2014 to 03
Harm edges or burrs atraumatic surface Jul 2017) period.
Irritation / edema/ ulceration/
erosion at mucosa (health tissue) Design solutions employed using state of the art
Temporary discomfort- medical features/ geometry/ materials which provide a
intervention not required high degree of assurance of robust designs
Implementation
18.3. Be 18.3.1. Is not corrosion resistant Situation Incorrect material Risk Control History shows 0 failure
corrosion Corrosion at Radiopaque selected - material Radiopaque marker material is Tantalum. (s) out of 14724 devices
resistant markers. is not resistant to Tantalum is a highly un-reactive and benign metal used in patients over a 3
corrosion which offers adequate corrosion resistance for year (03 Jul 2014 to 03
Harm this application Jul 2017) period.
Allergic reaction / toxic or
immune response Design solutions employed using state of the art Immersion Corrosion
approaches which address the cause of Testing representative of
5 Remote I 1 1 IIA Yes No N/A
Impact failure/failure mode. Such solutions relate to 52 weeks in vivo has
Permanent irreversible features/ geometry/ materials which provide a been completed for
impairment, life-threatening high degree of assurance of robust designs EVO-xx-yy-zz-D and
illness or injury established effective through clinical use. EVO-xx-yy-zz-C devices
per ref: VAL07-0015
Particulates of corrosion product selected - material Radiopaque marker material is Tantalum. (s) out of 14724 devices
or pieces detach from is not resistant to Tantalum is a highly un-reactive and benign metal used in patients over a 3
Radiopaque markers, and pass corrosion which offers adequate corrosion resistance for year (03 Jul 2014 to 03
through body 1 Likely III this application 1 Jul 2017) period. 1 III Yes No N/A
Harm Design solutions employed using state of the art Immersion Corrosion
No harm to patient approaches which address the cause of Testing representative of
Min
Has risk
Probability Is a
of Risk ?
?
Control
failure/failure mode. Such solutions relate to 52 weeks in vivo has
Impact features/ geometry/ materials which provide a been completed for
Nuisance to patient or end user established effective through clinical use. EVO-xx-yy-zz-C devices
per ref: VAL07-0015
Particulates of corrosion product selected - material Radiopaque marker material is Tantalum. (s) out of 14724 devices
or pieces detach from is not resistant to Tantalum is a highly un-reactive and benign metal used in patients over a 3
Radiopaque markers, and pass corrosion which offers adequate corrosion resistance for year (03 Jul 2014 to 03
through body this application Jul 2017) period.
Harm Design solutions employed using state of the art Immersion Corrosion
Minor trauma to mucosa approaches which address the cause of Testing representative of
Impact features/ geometry/ materials which provide a been completed for
Temporary discomfort- medical high degree of assurance of robust designs EVO-xx-yy-zz-D and
intervention not required established effective through clinical use. EVO-xx-yy-zz-C devices
per ref: VAL07-0015
19. Stent: 19.1. Remain 19.1.1. Markers do not remain joined Situation Incorrect material Risk Control History shows 0 failure
(Joint) Stent & joined The markers detach from the selection - Stiffness Radiopaque marker material is Tantalum as (s) out of 14724 devices
Marker Bands stent, fall into the patient and of components too specified by design. Stent material is Nitinol as used in patients over a 3
expels naturally through the low. specified by design. Both materials provide year (03 Jul 2014 to 03
patient's GI tract. adequate level of stiffness to ensure they remain Jul 2017) period.
joined and intact.
Harm
Implementation
1 Likely III Incorrect Joining Risk Control History shows 0 failure
Method The marker bands (tantalum) are attached to the (s) out of 14724 devices
Stent (Nitinol) with silicone as specified by design, used in patients over a 3
which provides sufficient joint strength to resist year (03 Jul 2014 to 03
forces applied during use. Jul 2017) period.

1 1 III Yes No N/A
Implementation
The markers detach from the selection - Stiffness Radiopaque marker material is Tantalum as (s) out of 14724 devices
stent, difficuty to provide follow of components too specified by design. Stent material is Nitinol as used in patients over a 3
up post procedure low. specified by design. Both materials provide year (03 Jul 2014 to 03
adequate level of stiffness to ensure they remain Jul 2017) period.
Harm joined and intact.
Reocclusion occurs, requiring 4 Unlikely IIB 1 1 IIA Yes No N/A
secondary intervention Design solutions employed using state of the art
Harm requiring secondary features/ geometry/ materials which provide a
intervention and/ or prolonged high degree of assurance of robust designs
Min
Has risk
Probability Is a
of Risk ?
?
Control
hospitalisation required established effective through clinical use.
Implementation
Incorrect Joining Risk Control History shows 0 failure
Method The marker bands (tantalum) are attached to the (s) out of 14724 devices
Stent (Nitinol) with silicone as specified by design, used in patients over a 3
which provides sufficient joint strength to resist year (03 Jul 2014 to 03
forces applied during use. Jul 2017) period.

1 1 IIA Yes No N/A
Implementation
19.2. Be 19.2.1. Is not corrosion resistant Situation Incorrect stent Risk Control History shows 0 failure
corrosion Particulates of corrosion product surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
resistant or pieces detach from Stent does not design used in patients over a 3
stent/marker bands. Particulates have a smooth year (03 Jul 2014 to 03
pass through GI tract surface Design solutions employed using state of the art Jul 2017) period.
failure/failure mode. Such solutions relate to Immersion Corrosion
1 1 III Yes No N/A
Harm features/ geometry/ materials which provide a Testing representative of
No harm to patient high degree of assurance of robust designs 52 weeks in vivo has
established effective through clinical use. been completed for
Impact EVO-xx-yy-zz-D and
No health consequence/ Implementation EVO-xx-yy-zz-C devices
Nuisance to patient or end user DWG0288 'Enteral Stent ' per ref: VAL07-0015
selection: Stent material is Nitinol and marker bands (s) out of 14724 devices
Stent/marker material is Tantalum as specified by design, used in patients over a 3
bands material which comprises of a nickel and titanium mix and year (03 Jul 2014 to 03
corrodes within the Tantalum material is a highly un-reactive and Jul 2017) period.
body environment benign metal which offers adequate corrosion
resistance for this application. Immersion Corrosion
Testing representative of
Design solutions employed using state of the art 52 weeks in vivo has
1 1 III Yes No N/A
1 Likely III failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
Implementation
Incompatible Risk Control History shows 0 failure
material: Stent material is Nitinol and marker bands (s) out of 14724 devices
Stent material and material is Tantalum as specified by design, used in patients over a 3
Marker bands offers adequate corrosion compatibility when year (03 Jul 2014 to 03
material are interact together. Jul 2017) period.
incompatible.
Design solutions employed using state of the art Immersion Corrosion
failure/failure mode. Such solutions relate to 1 52 weeks in vivo has 1 III Yes No N/A
features/ geometry/ materials which provide a been completed for
per ref: VAL07-0015
Min
Has risk
Probability Is a
of Risk ?
?
Control
Situation Incorrect stent Risk Control History shows 0 failure
Stent/marker band corrodes surface finish - Stent has a smooth surface as specified by (s) out of 14724 devices
within the GI tract Stent does not design used in patients over a 3
Harm surface Design solutions employed using state of the art Jul 2017) period.
Allergic reaction / toxic or approaches which address the cause of
immune response failure/failure mode. Such solutions relate to Immersion Corrosion
1 1 IIA Yes No N/A
features/ geometry/ materials which provide a Testing representative of
Impact high degree of assurance of robust designs 52 weeks in vivo has
Permanent irreversible established effective through clinical use. been completed for
impairment, life-threatening EVO-xx-yy-zz-D and
illness or injury Implementation EVO-xx-yy-zz-C devices
selection: Stent material is Nitinol and marker bands (s) out of 14724 devices
Stent/marker material is Tantalum as specified by design, used in patients over a 3
bands material which comprises of a nickel and titanium mix and year (03 Jul 2014 to 03
corrodes within the Tantalum material is a highly un-reactive and Jul 2017) period.
body environment benign metal which offers adequate corrosion
resistance for this application. Immersion Corrosion
Testing representative of
Design solutions employed using state of the art 52 weeks in vivo has
1 1 IIA Yes No N/A
5 Remote I
Implementation
Incompatible Risk Control History shows 0 failure
material: Stent material is Nitinol and marker bands (s) out of 14724 devices
Stent material and material is Tantalum as specified by design, used in patients over a 3
Marker bands offers adequate corrosion compatibility when year (03 Jul 2014 to 03
material are interact together. Jul 2017) period.
incompatible.
Design solutions employed using state of the art Immersion Corrosion
1 1 IIA Yes No N/A
features/ geometry/ materials which provide a been completed for
per ref: VAL07-0015
19.3. Be 19.3.1. Not atraumatic Situation Incorrect geometry Risk Control History shows 0 failure
atraumat Stent & radiopaque marker joint - marker bands Radiopaque marker has appropriate surface with (s) out of 14724 devices
ic rubs against stricture wall joint with stent has no sharp edges and covered by a layer of used in patients over a 3
a rough surface protective silicone to ensure the joint has an year (03 Jul 2014 to 03
Harm with sharp edges or atraumatic surface Jul 2017) period.
Minor trauma to mucosa burrs
1 1 IIA Yes No N/A
Temporary discomfort- medical failure/failure mode. Such solutions relate to
intervention not required features/ geometry/ materials which provide a
2 Likely IIA
Implementation
Incorrect marker Risk Control History shows 0 failure
band surface finish Stent has a smooth surface as specified by (s) out of 14724 devices
-Marker band does design used in patients over a 3
not have a smooth 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
surface has a Design solutions employed using state of the art Jul 2017) period.
rough surface with approaches which address the cause of
sharp edges or failure/failure mode. Such solutions relate to
Min
Has risk
Probability Is a
of Risk ?
?
Control
burrs features/ geometry/ materials which provide a
Implementation
19.4. Stent 19.4.1. Stent is not visible under Situation Incorrect material Risk Control History shows 0 failure
must be fluoroscopy Unable to verify stent position. selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
visible Stent deployed in incorrect Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
using location. Lesion goes untreated. material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
fluorosco visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
py Harm fluoroscopy adequately visible under fluoroscopy
Irritation / edema/ ulceration/ Fluoroscopic Visibility
erosion at mucosa (health tissue) Design solutions employed using state of the art Testing [in a clinical
approaches which address the cause of setting] has been
Temporary discomfort- medical features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
intervention not required high degree of assurance of robust designs zz-C devices per ref:
Rev 1
1 1 IIA Yes No N/A
C product(s) tested
Simulated Use Testing:
Deployment Testing [in a
clinical setting] has been
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
- dimensions are Tantalum Marker ID is compatible with the OD of (s) out of 14724 devices
2 Likely IIA not compatible the Stent wire as specified by design to allow the used in patients over a 3
marker to fit over the wire year (03 Jul 2014 to 03
Jul 2017) period.
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Incorrect joining Risk Control History shows 0 failure
method - Marker The marker band (tantalum), Stent (Nitinol) and (s) out of 14724 devices
band and stent has silicone (MED-4755) are specified by design for 1 used in patients over a 3 1 IIA Yes No N/A
bond strength too the bond/joint to remain intact throughout use. year (03 Jul 2014 to 03
low Jul 2017) period.
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Unable to verify stent position. selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
Stent deployed in incorrect Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
location. Lesion goes untreated. material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
Another stent required to visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
complete the procedure. fluoroscopy adequately visible under fluoroscopy
Fluoroscopic Visibility
Harm approaches which address the cause of setting] has been
Continuation of occlusion (which failure/failure mode. Such solutions relate to completed for EVO-xx-
can be treated within the same features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
procedure) high degree of assurance of robust designs zz-C devices per ref:
Impact Rev 1
Harm requiring medical Implementation EVO-xx-yy-zz-D
1 1 IIA Yes No N/A
intervention, within the same DWG0288 'Enteral Stent ' products are of similar
operating procedure. No further DWG0289 'Colonic Stent' design to EVO-xx-yy-zz-
hospital stay required C product(s) tested
3 Likely IIB VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
not compatible the Stent wire as specified by design to allow the used in patients over a 3
Jul 2017) period.
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
band and stent has silicone (MED-4755) are specified by design for used in patients over a 3
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Full stent expansion cannot be selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
fluoroscopically confirmed. Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
Migration of stent occurred during material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
removal of introduction system. visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Harm Fluoroscopic Visibility
Continuation of occlusion (which Design solutions employed using state of the art Testing [in a clinical
can be treated within the same approaches which address the cause of setting] has been
procedure) failure/failure mode. Such solutions relate to completed for EVO-xx-
Impact high degree of assurance of robust designs zz-C devices per ref:
Harm requiring medical established effective through clinical use. VAL08-0011 REPORT
intervention, within the same Rev 1
operating procedure. No further Implementation EVO-xx-yy-zz-D
hospital stay required 3 Likely IIB DWG0288 'Enteral Stent ' 1 products are of similar 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
Jul 2017) period.
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Full stent expansion cannot be selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
fluoroscopically confirmed. Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
Migration of stent occurred during material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
removal of introduction system. visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Harm 4 Unlikely IIB 1 Fluoroscopic Visibility 1 IIA Yes No N/A
Reocclusion occurs, requiring Design solutions employed using state of the art Testing [in a clinical
secondary intervention approaches which address the cause of setting] has been
Impact features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
Harm requiring secondary high degree of assurance of robust designs zz-C devices per ref:
intervention and/ or prolonged established effective through clinical use. VAL08-0011 REPORT
Min
Has risk
Probability Is a
of Risk ?
?
Control
hospitalisation required Rev 1
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Jul 2017) period.
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
DWG0288 'Enteral Stent ' 1 Rev 1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D
C product(s) tested
Marker bands dislodge from stent selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
and pass through the patient's GI Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
tract. material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Harm fluoroscopy adequately visible under fluoroscopy
No retrieval required. Fluoroscopic Visibility
Impact approaches which address the cause of setting] has been
No health consequence/ failure/failure mode. Such solutions relate to completed for EVO-xx-
Nuisance to patient or end user features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
Rev 1
1 1 III Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
1 Likely III Jul 2017) period.
1 1 III Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
low 1 Jul 2017) period. 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
Marker bands dislodge from stent selected - Tantalum marker material is Tantalum as (s) out of 14724 devices
and migrate into patient Tantalum marker specified by design. Tantalum was selected due used in patients over a 3
material is not to its linear attenuation is high enough at the year (03 Jul 2014 to 03
Harm visible under photo energy (keV) level of x-ray tubes to be Jul 2017) period.
Foreign body / matter left in fluoroscopy adequately visible under fluoroscopy
patient which can be retrieved Fluoroscopic Visibility
within the same procedure. Design solutions employed using state of the art Testing [in a clinical
approaches which address the cause of setting] has been
Harm requiring medical features/ geometry/ materials which provide a yy-zz-D and EVO-xx-yy-
intervention, within the same high degree of assurance of robust designs zz-C devices per ref:
operating procedure. No further established effective through clinical use. VAL08-0011 REPORT
hospital stay required Rev 1
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
3 Likely IIB
EVO-xx-yy-zz-D
C product(s) tested
Jul 2017) period.
established effective through clinical use. 1 yy-zz-D and EVO-xx-yy- 1 IIA Yes No N/A
C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
1 1 IIA Yes No N/A
C product(s) tested
VAL08-0011 REPORT
Rev 1
EVO-xx-yy-zz-D
C product(s) tested
20. Handle: 20.1. Prevent 20.1.1. Safety lock cannot prevent Situation Incorrect material - Risk Control Simulated Use Testing
(Red Safety inadverte premature deployment. Trigger accidently actuated. Material too brittle Material for red safety Lock is Lexan 241R as has been completed for
Lock) nt Device replaced. specified by design, has sufficient strength to EVO-xx-yy-zz-D and
deploym resist forces applied during use EVO-xx-yy-zz-C devices
ent of Harm Potential Cause of failure addressed per ref: NCT16-0036-R
stent Device replaced Ver 0
without a health Implementation EVO-xx-yy-zz-D
consequence. DWG0325 'SAFETY-LOCK' products are of similar
Impact C product(s) tested
20.2. Must be 20.2.1. Unable to withstand forces Situation Incorrect Risk Control Simulated Use Testing
able to generated prior to stent Trigger actuated prematurely in dimensions - wall The red safety Lock thickness as specified by has been completed for
withstan deployment incorrect location. Stent thickness of red design, has sufficient strength to resist forces EVO-xx-yy-zz-D and
d forces recaptured or Device replaced safety Lock too low applied during use EVO-xx-yy-zz-C devices
during Potential Cause of failure addressed per ref: NCT16-0036-R
use Harm 1 Likely III 1 Ver 0 1 III Yes No N/A
No harm to patient Implementation EVO-xx-yy-zz-D
DWG0325 'SAFETY-LOCK' products are of similar
Impact design to EVO-xx-yy-zz-
No health consequence/ C product(s) tested
20.3. Features 20.3.1. Safety lock cannot be removed Situation Incorrect geometry Risk Control Simulated Use Testing
designed from device Device cannot be used. - Red safety Lock The red safety Lock geometry as specified by has been completed for
in such a Replacement device required has no graspable design, has sufficient geometry to be adequately EVO-xx-yy-zz-D and
way so feature grasped by the user EVO-xx-yy-zz-C devices
that it is Harm 1 Likely III Potential Cause of failure addressed 1 per ref: NCT16-0036-R 1 III Yes No N/A
easily No harm to patient Ver 0
graspabl Implementation EVO-xx-yy-zz-D
e Impact DWG0325 'SAFETY-LOCK' products are of similar
No health consequence/ design to EVO-xx-yy-zz-
Min
Has risk
Probability Is a
of Risk ?
?
Control
Nuisance to patient or end user C product(s) tested
20.4. Must be 20.4.1. Safety lock cannot be removed Situation Incorrect material: Risk Control Simulated Use Testing
easily from device Device cannot be used. Surface finish is Material for the red safety Lock is Lexan 241R as has been completed for
detached Replacement device required too rough. Excess specified by design, has adequate surface EVO-xx-yy-zz-D and
from the friction with device roughness to allow it to be removed from the EVO-xx-yy-zz-C devices
handle Harm trigger device with applicable force per ref: NCT16-0036-R
No harm to patient Potential Cause of failure addressed Ver 0
EVO-xx-yy-zz-D
Impact Implementation products are of similar
No health consequence/ DWG0325 'SAFETY-LOCK' design to EVO-xx-yy-zz-
21. Handle: 21.1. Remain 21.1.1. Does not remain intact Situation Incorrect Risk Control History shows 0 failure
(Joint ) Outer intact Handle outer casing separates dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
shells & prior to patient contact, stent connecting pegs compatible and hold the handle together. used in patients over a 3
Nozzle 34 cannot be deployed. replacement and ID of receivers year (03 Jul 2014 to 03
device required. not compatible Design solutions employed using state of the art Jul 2017) period.
Harm failure/failure mode. Such solutions relate to Design verification of
No harm to patient features/ geometry/ materials which provide a Evolution Handle
high degree of assurance of robust designs components from
Impact established effective through clinical use. production moulds has
1 1 III Yes No N/A
No health consequence/ been completed for
Nuisance to patient or end user Implementation EVO-xx-yy-zz-D and
DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-C devices
per ref: VAL08-0058
REPORT Rev 0
tested
Materials not Material for the Handle outer casing is (s) out of 14724 devices
suitable for joining Polycarbonate/ABS Mix as specified by Design, is used in patients over a 3
suitable joining for an interference fit and year (03 Jul 2014 to 03
withstand forces applied during use. Jul 2017) period.
Design solutions employed using state of the art Design verification of

approaches which address the cause of Evolution Handle
failure/failure mode. Such solutions relate to components from
features/ geometry/ materials which provide a production moulds has
DWG0497 'TTS SEMS Assembly' REPORT Rev 0
tested
Incorrect assembly Risk Control History shows 0 failure
Method: The handle assembly is an interference fit as (s) out of 14724 devices
Insufficient specified by Design, which provides sufficient used in patients over a 3
assembly strength strength to withstand forces applied during use year (03 Jul 2014 to 03
Jul 2017) period.
approaches which address the cause of Design verification of
failure/failure mode. Such solutions relate to Evolution Handle
features/ geometry/ materials which provide a components from
high degree of assurance of robust designs production moulds has
established effective through clinical use. 1 been completed for 1 III Yes No N/A
EVO-xx-yy-zz-D and
Implementation EVO-xx-yy-zz-C devices
REPORT Rev 0
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
Incorrect material: Risk Control History shows 0 failure
Handle material Material for the Handle outer casing is (s) out of 14724 devices
cannot withstand aPolycarbonate/ABS Mix as specified by Design, used in patients over a 3
typical forces has sufficient strength to withstand typical forces year (03 Jul 2014 to 03
exerted during use exerted during use Jul 2017) period.

1 1 III Yes No N/A
tested
Handle Outer shell The Handle Outer Shell geometry as specified by (s) out of 14724 devices
geometry features design, features strengthening ribs and bosses to used in patients over a 3
do not provide withstand typical forces exerted during use. year (03 Jul 2014 to 03
sufficient strength Jul 2017) period.
to withstand typical Design solutions employed using state of the art
forces exerted approaches which address the cause of Design verification of
during use. failure/failure mode. Such solutions relate to Evolution Handle
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
DWG0455 'TTS Outer Shell Left' per ref: VAL08-0058
DWG0456 'TTS Outer Shell Right' REPORT Rev 0
tested
Geometry: Nozzle The nozzle geometry is designed to be (s) out of 14724 devices
geometry is not compatible with the geometry of the Handle Outer used in patients over a 3
compatible with Shell, as specified by design. year (03 Jul 2014 to 03
Handle Outer Shell Jul 2017) period.
geometry. Design solutions employed using state of the art
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
DWG0318 'Nozzle - 34' per ref: VAL08-0058
DWG0455 'TTS Outer Shell Left' REPORT Rev 0
DWG0456 'TTS Outer Shell Right' EVO-xx-yy-zz-C & EVO-
tested
Incorrect materials: Risk Control History shows 0 failure
Nozzle material The Nozzle material (Polycarbonate) was chosen (s) out of 14724 devices
cannot withstand to withstand forces applied during use, as used in patients over a 3
forces applied specified by design. year (03 Jul 2014 to 03
during use Jul 2017) period.
approaches which address the cause of 1 Design verification of 1 III Yes No N/A
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT Rev 0
tested
Dimensions: The The Nozzle OD is designed to be compatible with (s) out of 14724 devices
OD of the Nozzle is the ID of the Handle Outer Shell, as specified by used in patients over a 3
not compatible with design. year (03 Jul 2014 to 03
the ID of the Jul 2017) period.
Handle Outer Shell Design solutions employed using state of the art
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
Incorrect Geometry Risk Control History shows 0 failure
- handle does not Component retaining grooves and sockets within (s) out of 14724 devices
accommodate the handle are designed by the manufacturer to fit used in patients over a 3
internal year (03 Jul 2014 to 03
components Design solutions employed using state of the art Jul 2017) period.
failure/failure mode. Such solutions relate to Design verification of
features/ geometry/ materials which provide a Evolution Handle
established effective through clinical use. production moulds has
1 1 III Yes No N/A
been completed for
Implementation EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Handle outer casing separates dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
during procedure, stent cannot be connecting pegs compatible and hold the handle together. used in patients over a 3
deployed. replacement device and ID of receivers year (03 Jul 2014 to 03
required. not compatible Design solutions employed using state of the art Jul 2017) period.
Additional exposure to sedation, features/ geometry/ materials which provide a Evolution Handle
radiation and/or contrast high degree of assurance of robust designs components from
1 1 IIA Yes No N/A
Impact been completed for
Temporary discomfort- medical Implementation EVO-xx-yy-zz-D and
intervention not required 2 Likely IIA DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-C devices
per ref: VAL08-0058
REPORT Rev 0
tested
Materials not Material for the Handle outer casing is 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control

tested
Jul 2017) period.
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested

1 1 IIA Yes No N/A
tested
during use. failure/failure mode. Such solutions relate to 1 Evolution Handle 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
internal 1 year (03 Jul 2014 to 03 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
Handle outer casing separates dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
during procedure, stent is connecting pegs compatible and hold the handle together. used in patients over a 3
partially deployed, cannot and ID of receivers year (03 Jul 2014 to 03
recapture stent replacement not compatible Design solutions employed using state of the art Jul 2017) period.
device required. approaches which address the cause of
Harm features/ geometry/ materials which provide a Evolution Handle
Additional exposure to sedation, high degree of assurance of robust designs components from
radiation and/or contrast established effective through clinical use. production moulds has
1 1 IIA Yes No N/A
been completed for
Impact Implementation EVO-xx-yy-zz-D and
Temporary discomfort- medical DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-C devices
intervention not required per ref: VAL08-0058
REPORT Rev 0
tested

2 Likely IIA features/ geometry/ materials which provide a production moulds has
1 1 IIA Yes No N/A
tested
Jul 2017) period.
high degree of assurance of robust designs 1 production moulds has 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested

1 1 IIA Yes No N/A
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
during use 1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
Handle outer casing breaks dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
during procedure, sharp injury connecting pegs compatible and hold the handle together. used in patients over a 3
hazard to user. replacement and ID of receivers year (03 Jul 2014 to 03
device required. not compatible Design solutions employed using state of the art Jul 2017) period.
Minor cut injury to user features/ geometry/ materials which provide a Evolution Handle
Temporary discomfort- medical 2 Likely IIA 1 been completed for 1 IIA Yes No N/A
intervention not required Implementation EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control

1 1 IIA Yes No N/A
tested
Jul 2017) period.
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested

1 1 IIA Yes No N/A
tested
forces exerted approaches which address the cause of 1 Design verification of 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
- handle does not Component retaining grooves and sockets within 1 (s) out of 14724 devices 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
Nozzle falls into patient. dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
Component passes naturally connecting pegs compatible and hold the handle together. used in patients over a 3
through the patient's GI Tract. and ID of receivers year (03 Jul 2014 to 03
not compatible Design solutions employed using state of the art Jul 2017) period.
No retrieval required. failure/failure mode. Such solutions relate to Design verification of
Impact high degree of assurance of robust designs components from
No health consequence/ established effective through clinical use. production moulds has
1 1 III Yes No N/A
Nuisance to patient or end user been completed for
per ref: VAL08-0058
REPORT Rev 0
tested

1 Likely III approaches which address the cause of Evolution Handle
1 1 III Yes No N/A
tested
Jul 2017) period.
failure/failure mode. Such solutions relate to 1 Evolution Handle 1 III Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested

1 1 III Yes No N/A
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
forces applied specified by design. 1 year (03 Jul 2014 to 03 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 III Yes No N/A
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
Nozzle falls into patient. dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
Endoscopic retrieval required connecting pegs compatible and hold the handle together. used in patients over a 3
and ID of receivers year (03 Jul 2014 to 03
Harm not compatible Design solutions employed using state of the art Jul 2017) period.
Foreign body / matter left in approaches which address the cause of
patient which can be retrieved failure/failure mode. Such solutions relate to Design verification of
within the same procedure. features/ geometry/ materials which provide a Evolution Handle
Impact 3 Likely IIB established effective through clinical use. 1 production moulds has 1 IIA Yes No N/A
Harm requiring medical been completed for
intervention, within the same Implementation EVO-xx-yy-zz-D and
operating procedure. No further DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-C devices
hospital stay required per ref: VAL08-0058
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested

1 1 IIA Yes No N/A
tested
Jul 2017) period.
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested

1 1 IIA Yes No N/A
tested
sufficient strength 1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
established effective through clinical use. 1 been completed for 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
1 1 IIA Yes No N/A
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
Internal Components move dimensions - OD of Connecting Pegs and sockets are designed to be (s) out of 14724 devices
during procedure and prevent the connecting pegs compatible and hold the handle together. used in patients over a 3
device from functioning. and ID of receivers year (03 Jul 2014 to 03
Replacement device required. not compatible Design solutions employed using state of the art Jul 2017) period.
Insignificant delay in procedure. features/ geometry/ materials which provide a Evolution Handle
1 1 III Yes No N/A
No health consequence/ been completed for
Nuisance to patient or end user Implementation EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
1 Likely III Design solutions employed using state of the art Design verification of
1 1 III Yes No N/A
tested
Jul 2017) period.
approaches which address the cause of 1 Design verification of 1 III Yes No N/A
EVO-xx-yy-zz-D and
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT Rev 0
tested

1 1 III Yes No N/A
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
Nozzle material The Nozzle material (Polycarbonate) was chosen 1 (s) out of 14724 devices 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
REPORT Rev 0
tested
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
tested
1 1 III Yes No N/A
been completed for
per ref: VAL08-0058
REPORT Rev 0
tested
21.2. Indicate 21.2.1. Stent position and point of no Situation No label or visual Risk Control The effectiveness is
stent return not indicated Stent is not deployed in correct warning to indicate Handle label details the amount of stent deployed inherent in the risk
deploym location. Another stent required stent position of with respect to the point of no return. control
ent to complete the procedure. point of no return.
threshold Protective measures built into the device itself i.e.
in Harm visual indicators, user feedback methods etc,
respect Continuation of occlusion (which identify to the user when to take certain actions
to point can be treated within the same 3 Likely IIB but do not completely eliminate the likelihood of 2 2 IIA Yes No N/A
of no procedure) occurrence as the user may not observe the
return measures
position Impact
operating procedure. No further RMS0046 'SEMS "Point of no return" Label'
Min
Has risk
Probability Is a
of Risk ?
?
Control
Situation No label or visual Risk Control The effectiveness is
No indication of the "point of no warning to indicate Handle label details the amount of stent deployed inherent in the risk
return" stent cannot be fully stent position of with respect to the point of no return. control
recaptured, partially deployed point of no return.
stent needs to be removed. Protective measures built into the device itself i.e.
Another stent required to visual indicators, user feedback methods etc,
complete the procedure. identify to the user when to take certain actions
2 Likely IIA but do not completely eliminate the likelihood of 2 2 IIA Yes No N/A
Harm occurrence as the user may not observe the
Additional exposure to sedation, measures
Temporary discomfort- medical RMS0046 'SEMS "Point of no return" Label'
21.3. Indicate 21.3.1. Product Stent Size not indicated Situation No label or visual Risk Control History shows 0 failure
stent Stent size cannot be confirmed, indication of stent Labelling details the stent size (s) out of 14724 devices
size replacement device required. size used in patients over a 3
(as Design solutions employed using state of the art year (03 Jul 2014 to 03
implied Harm approaches which address the cause of Jul 2017) period.
by No harm to patient failure/failure mode. Such solutions relate to
product features/ geometry/ materials which provide a
RPN) Impact high degree of assurance of robust designs Simulated Use Testing
No health consequence/ 1 Likely III established effective through clinical use. 1 has been completed for 1 III Yes No N/A
Nuisance to patient or end user EVO-xx-yy-zz-D and
RMS0046 'SEMS "Point of no return" Label' per ref: NCT16-0036-R
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
Situation No label or visual Risk Control History shows 0 failure
Incorrect stent size used on indication of stent Labelling details the stent size (s) out of 14724 devices
patient, stent too small, stent size used in patients over a 3
migrates. Design solutions employed using state of the art year (03 Jul 2014 to 03
approaches which address the cause of Jul 2017) period.
Continuation of occlusion (which features/ geometry/ materials which provide a
can be treated within the same high degree of assurance of robust designs Simulated Use Testing
procedure) 3 Likely IIB established effective through clinical use. 1 has been completed for 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
Impact Implementation EVO-xx-yy-zz-C devices
Harm requiring medical RMS0046 'SEMS "Point of no return" Label' per ref: NCT16-0036-R
intervention, within the same Ver 0
operating procedure. No further EVO-xx-yy-zz-D
hospital stay required products are of similar
C product(s) tested
patient, stent too large. Excess size used in patients over a 3
force applied to GI Tract Design solutions employed using state of the art year (03 Jul 2014 to 03
Perforation and/or minor bleed features/ geometry/ materials which provide a
(self-limited) high degree of assurance of robust designs Simulated Use Testing
3 Likely IIB established effective through clinical use. 1 has been completed for 1 IIA Yes No N/A
Impact EVO-xx-yy-zz-D and
Harm requiring medical Implementation EVO-xx-yy-zz-C devices
intervention, within the same RMS0046 'SEMS "Point of no return" Label' per ref: NCT16-0036-R
operating procedure. No further Ver 0
hospital stay required EVO-xx-yy-zz-D
C product(s) tested
patient, stent too large. Excess 4 Unlikely IIB size 1 used in patients over a 3 1 IIA Yes No N/A
force applied to GI Tract Design solutions employed using state of the art year (03 Jul 2014 to 03
Min
Has risk
Probability Is a
of Risk ?
?
Control
Perforation (medical intervention features/ geometry/ materials which provide a
required) and/or major bleed high degree of assurance of robust designs Simulated Use Testing
(transfusion required) established effective through clinical use. has been completed for
EVO-xx-yy-zz-D and
Impact Implementation EVO-xx-yy-zz-C devices
Harm requiring secondary RMS0046 'SEMS "Point of no return" Label' per ref: NCT16-0036-R
intervention and/ or prolonged Ver 0
hospitalisation required EVO-xx-yy-zz-D
C product(s) tested
21.4. Be 21.4.1. Not Graspable Situation Incorrect material: Risk Control History shows 0 failure
graspabl Handle can not be grasped. Handle material too Material for the handle is a Polycarbonate/ABS (s) out of 14724 devices
e Replacement device required. soft/ ductile. mix as specified by Design, has sufficient strength used in patients over a 3
to resist forces applied during use and to be year (03 Jul 2014 to 03
Harm adequately grasped by the user. Jul 2017) period.
No harm to patient
Impact approaches which address the cause of Simulated Use Testing
No health consequence/ failure/failure mode. Such solutions relate to has been completed for
Nuisance to patient or end user features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
Ver 0
DWG0496 'TTS HANDLE Assembly' products are of similar
DWG0497 'TTS SEMS Assembly' 1 design to EVO-xx-yy-zz- 1 III Yes No N/A
C product(s) tested
Design verification of
Evolution Handle
components from
production moulds has
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
1 Likely III
- Handle not The handle geometry as specified by Design is (s) out of 14724 devices
graspable closed hand shaped and has raised edges to be used in patients over a 3
adequately grasped by the user. year (03 Jul 2014 to 03
Jul 2017) period.
DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-D
1 design to EVO-xx-yy-zz- 1 III Yes No N/A
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
Situation Incorrect material: Risk Control History shows 0 failure
Handle can not be grasped Handle material too Material for the handle is a Polycarbonate/ABS (s) out of 14724 devices
during stent deployment. Stent soft/ ductile. mix as specified by Design, has sufficient strength used in patients over a 3
deployed with difficulty. to resist forces applied during use and to be year (03 Jul 2014 to 03
Prolonged procedure. adequately grasped by the user. Jul 2017) period.

Temporary discomfort- medical established effective through clinical use. per ref: NCT16-0036-R
intervention not required Ver 0
DWG0497 'TTS SEMS Assembly' 1 design to EVO-xx-yy-zz- 1 IIA Yes No N/A
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
2 Likely IIA
Jul 2017) period.
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Situation Incorrect material: Risk Control History shows 0 failure
Handle can not be grasped Handle material too Material for the handle is a Polycarbonate/ABS (s) out of 14724 devices
during stent deployment. Stent soft/ ductile. mix as specified by Design, has sufficient strength used in patients over a 3
deployed with difficulty. to resist forces applied during use and to be year (03 Jul 2014 to 03
Prolonged procedure. 2 Likely IIA adequately grasped by the user. 1 Jul 2017) period. 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Jul 2017) period.
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
21.5. Provide 21.5.1. No movement guide provided Situation Incorrect geometry Risk Control History shows 0 failure
positiona for trigger mechanism Trigger does not engage drive - Handle does not The handle geometry as specified by Design has (s) out of 14724 devices
l gears, device cannot be used. align to provide a track built in to accommodate the trigger and used in patients over a 3
moveme Replacement device required. movement track trigger movement year (03 Jul 2014 to 03
nt track Jul 2017) period.
for Harm Design solutions employed using state of the art
trigger No harm to patient approaches which address the cause of
Nuisance to patient or end user 1 Likely III established effective through clinical use. 1 EVO-xx-yy-zz-C devices 1 III Yes No N/A
C product(s) tested
Evolution Handle
components from
Min
Has risk
Probability Is a
of Risk ?
?
Control
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Handle material Material for the handle is Polycarbonate/ABS Mix (s) out of 14724 devices
does not allow as specified by Design, this material allows for used in patients over a 3
smooth movement smooth movement. year (03 Jul 2014 to 03
Jul 2017) period.
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
21.6. Indicate 21.6.1. Does not indicate directional Situation No label or visual Risk Control History shows 0 failure
deploym movement of system Incorrect directional movement of warning to indicate Printed visual indicators on the handle shell as (s) out of 14724 devices
ent / introducer system engaged. deployment or specified by design used in patients over a 3
recaptur Minor movement before it is recapture direction. year (03 Jul 2014 to 03
e noticed and changed to correct Design solutions employed using state of the art Jul 2017) period.
direction function. approaches which address the cause of
Harm features/ geometry/ materials which provide a Simulated Use Testing
No harm to patient 1 Likely III high degree of assurance of robust designs 1 has been completed for 1 III Yes No N/A
Impact EVO-xx-yy-zz-C devices
No health consequence/ Implementation per ref: NCT16-0036-R
Nuisance to patient or end user DWG0455 'TTS Outer Shell Left' Ver 0
DWG0456 'TTS Outer Shell Right' EVO-xx-yy-zz-D
C product(s) tested
Incorrect functional movement warning to indicate Printed visual indicators on the handle shell as (s) out of 14724 devices
selected, during repositioning, deployment or specified by design used in patients over a 3
stent is deployed instead of recapture direction. year (03 Jul 2014 to 03
recaptured. Endoscopic Design solutions employed using state of the art Jul 2017) period.
repositioning is necessary. approaches which address the cause of
IFU warns that this may cause 3 Likely IIB failure/failure mode. Such solutions relate to 1 1 IIA Yes No N/A
damage to mucosa. features/ geometry/ materials which provide a Simulated Use Testing
high degree of assurance of robust designs has been completed for
Harm established effective through clinical use. EVO-xx-yy-zz-D and
Perforation and/or minor bleed EVO-xx-yy-zz-C devices
(self-limited) Implementation per ref: NCT16-0036-R
DWG0455 'TTS Outer Shell Left' Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact DWG0456 'TTS Outer Shell Right' EVO-xx-yy-zz-D
Harm requiring medical products are of similar
intervention, within the same design to EVO-xx-yy-zz-
operating procedure. No further C product(s) tested
Incorrect functional movement warning to indicate Printed visual indicators on the handle shell as (s) out of 14724 devices
selected, during repositioning, deployment or specified by design used in patients over a 3
stent is deployed instead of recapture direction. year (03 Jul 2014 to 03
recaptured. Endoscopic Design solutions employed using state of the art Jul 2017) period.
repositioning is necessary. approaches which address the cause of
IFU warns that this may cause failure/failure mode. Such solutions relate to
damage to mucosa. features/ geometry/ materials which provide a Simulated Use Testing
4 Unlikely IIB 1 1 IIA Yes No N/A
Harm established effective through clinical use. EVO-xx-yy-zz-D and
Perforation (medical intervention EVO-xx-yy-zz-C devices
required) and/or major bleed Implementation per ref: NCT16-0036-R
(transfusion required) DWG0455 'TTS Outer Shell Left' Ver 0
Impact products are of similar
Harm requiring secondary design to EVO-xx-yy-zz-
intervention and/ or prolonged C product(s) tested
21.7. Handle 21.7.1. Handle is not easily operated Situation Incorrect geometry Risk Control Simulated Use Testing
must be using left or right hands Handle can only be operated by - Handle is not The handle geometry has been designed for use, has been completed for
for left or either the left or right hands compatible with and to fit for single hand use. It has an ergonomic EVO-xx-yy-zz-D and
right single handed use handle which conforms to the shape of either left EVO-xx-yy-zz-C devices
handed Harm or right hand per ref: NCT16-0036-R
use No harm to patient or end user Risk mitigated by product Design features Ver 0
EVO-xx-yy-zz-D
No health consequence/ DWG0496 'TTS HANDLE Assembly' design to EVO-xx-yy-zz-
Nuisance to patient or end user DWG0497 'TTS SEMS Assembly' C product(s) tested
21.8. Must 21.8.1. Directional switch is inoperable Situation Incorrect geometry Risk Control Simulated Use Testing
allow The stent can only be either - Handle does not The handle design as specified, allows for ease of has been completed for
access deployed or recaptured. Device allow access to the access to the directional switch EVO-xx-yy-zz-D and
to replaced directional switch Risk mitigated by product Design features EVO-xx-yy-zz-C devices
direction per ref: NCT16-0036-R
al Harm 1 Likely III Implementation 1 Ver 0 1 III Yes No N/A
change No harm to patient DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-D
switch DWG0497 'TTS SEMS Assembly' products are of similar
Impact design to EVO-xx-yy-zz-
No health consequence/ C product(s) tested
21.9. Nozzle 21.9.1. Outer sheath exits the handle in Situation Incorrect Risk Control Simulated Use Testing
acts as a an uncontrollable path Stent cannot be deployed. Device Dimensions- ID of The Dimensions of the components as specified has been completed for
guide for replaced. nozzle not by design, are compatible for purpose EVO-xx-yy-zz-D and
the outer compatible with OD Potential Cause of failure addressed EVO-xx-yy-zz-C devices
sheath Harm of outer sheath. per ref: NCT16-0036-R
when Insignificant delay in procedure. Implementation Ver 0
exiting DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-D
the Impact DWG0318 'Nozzle - 34' products are of similar
handle No health consequence/ DWG0497 'TTS SEMS Assembly' design to EVO-xx-yy-zz-
Situation Incorrect Risk Control Simulated Use Testing
Physician/ Assistant deploys Dimensions- ID of The Dimensions of the components as specified has been completed for
stent with difficulty nozzle not by design, are compatible for purpose EVO-xx-yy-zz-D and
compatible with OD Potential Cause of failure addressed EVO-xx-yy-zz-C devices
Harm of outer sheath. per ref: NCT16-0036-R
No harm to patient Implementation Ver 0
Impact DWG0318 'Nozzle - 34' products are of similar
No health consequence/ DWG0497 'TTS SEMS Assembly' design to EVO-xx-yy-zz-
Physician/ Assistant deploys Dimensions- ID of The Dimensions of the components as specified has been completed for
stent with difficulty nozzle not by design, are compatible for purpose EVO-xx-yy-zz-D and
2 Likely IIA compatible with OD Potential Cause of failure addressed 1 EVO-xx-yy-zz-C devices 1 IIA Yes No N/A
Harm of outer sheath. per ref: NCT16-0036-R
Minor trauma to mucosa Implementation Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact DWG0318 'Nozzle - 34' products are of similar
Temporary discomfort- medical DWG0497 'TTS SEMS Assembly' design to EVO-xx-yy-zz-
intervention not required C product(s) tested
Physician/Assistant deploys stent Dimensions- ID of The Dimensions of the components as specified has been completed for
at incorrect location. Another nozzle not by design, are compatible for purpose EVO-xx-yy-zz-D and
stent is required to complete the compatible with OD Potential Cause of failure addressed EVO-xx-yy-zz-C devices
procedure. of outer sheath. per ref: NCT16-0036-R
Harm DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-D
Continuation of occlusion (which DWG0318 'Nozzle - 34' products are of similar
can be treated within the same DWG0497 'TTS SEMS Assembly' design to EVO-xx-yy-zz-
procedure) C product(s) tested
Impact
21.10. Provide 21.10.1. Does not support components Situation Incorrect material - Risk Control Simulated Use Testing
housing Device cannot be used. Handle material is Material for the Handle outer casing is a has been completed for
for Replacement device required. too ductile Polycarbonate/ABS Mix as specified by Design EVO-xx-yy-zz-D and
compon has sufficient strength to resist forces applied EVO-xx-yy-zz-C devices
ents Harm during use. per ref: NCT16-0036-R
1 1 III Yes No N/A
No harm to patient or end user Risk mitigated by product Design features Ver 0
EVO-xx-yy-zz-D
No health consequence/ DWG0455 'TTS Outer Shell Left' design to EVO-xx-yy-zz-
Nuisance to patient or end user DWG0456 'TTS Outer Shell Right' C product(s) tested
1 Likely III
Incorrect Risk Control Simulated Use Testing
dimensions - The handle wall thickness as specified by Design, has been completed for
Handle wall has sufficient strength to resist forces applied EVO-xx-yy-zz-D and
thickness is too low during use. EVO-xx-yy-zz-C devices
Risk mitigated by product Design features per ref: NCT16-0036-R
1 1 III Yes No N/A
Ver 0
DWG0455 'TTS Outer Shell Left' products are of similar
DWG0456 'TTS Outer Shell Right' design to EVO-xx-yy-zz-
C product(s) tested
21.10.2. Handle does not retain Situation Incorrect material - Risk Control Simulated Use Testing
components in necessary Internal components are not kept Handle material is Material for the Handle outer casing is a has been completed for
location in correct position before use, too ductile Polycarbonate/ABS Mix as specified by Design EVO-xx-yy-zz-D and
device cannot be used. has sufficient strength to resist forces applied EVO-xx-yy-zz-C devices
Replacement device required during use and retain component position per ref: NCT16-0036-R
1 1 III Yes No N/A
Risk mitigated by product Design features Ver 0
Harm EVO-xx-yy-zz-D
No harm to patient or end user Implementation products are of similar
DWG0455 'TTS Outer Shell Left' design to EVO-xx-yy-zz-
Impact DWG0456 'TTS Outer Shell Right' C product(s) tested
No health consequence/ 1 Likely III
Nuisance to patient or end user Incorrect Geometry Risk Control Simulated Use Testing
- handle does not Component retaining grooves and sockets within has been completed for
accommodate the handle are designed by the manufacturer to fit EVO-xx-yy-zz-D and
internal Potential Cause of failure addressed EVO-xx-yy-zz-C devices
components per ref: NCT16-0036-R
1 1 III Yes No N/A
DWG0455 'TTS Outer Shell Left' EVO-xx-yy-zz-D
DWG0456 'TTS Outer Shell Right' products are of similar
C product(s) tested
Situation Incorrect material - Risk Control Simulated Use Testing
Components move during Handle material is Material for the Handle outer casing is a has been completed for
procedure and prevent the device too ductile Polycarbonate/ABS Mix as specified by Design EVO-xx-yy-zz-D and
from functioning. Replacement has sufficient strength to resist forces applied EVO-xx-yy-zz-C devices
device required. during use and retain component position per ref: NCT16-0036-R
2 Likely IIA Risk mitigated by product Design features 1 Ver 0 1 IIA Yes No N/A
Harm EVO-xx-yy-zz-D
Additional exposure to sedation, Implementation products are of similar
radiation and/or contrast DWG0455 'TTS Outer Shell Left' design to EVO-xx-yy-zz-
DWG0456 'TTS Outer Shell Right' C product(s) tested
Min
Has risk
Probability Is a
of Risk ?
?
Control
Impact Incorrect Geometry Risk Control Simulated Use Testing
Temporary discomfort- medical - handle does not Component retaining grooves and sockets within has been completed for
intervention not required accommodate the handle are designed by the manufacturer to fit EVO-xx-yy-zz-D and
internal Potential Cause of failure addressed EVO-xx-yy-zz-C devices
components per ref: NCT16-0036-R
1 1 IIA Yes No N/A
DWG0455 'TTS Outer Shell Left' EVO-xx-yy-zz-D
DWG0456 'TTS Outer Shell Right' products are of similar
C product(s) tested
22. Handle 22.1. Provide 22.1.1. Does not provide an adequate Situation Incorrect Risk Control History shows 0 failure
(Interaction) - Endstop endstop Handle casing fails to provide an dimensions - Shuttle dimensions and handle as specified by (s) out of 14724 devices
Shuttle + endstop for the shuttle. Device Geometry of design are compatible with each other used in patients over a 3
Handle casing replaced components are year (03 Jul 2014 to 03
not compatible Design solutions employed using state of the art Jul 2017) period.
Device replaced failure/failure mode. Such solutions relate to
without a health features/ geometry/ materials which provide a Simulated Use Testing
consequence. 1 Likely III high degree of assurance of robust designs 1 has been completed for 1 III Yes No N/A
Nuisance to patient or end user DWG0455 'TTS Outer Shell Left' Ver 0
C product(s) tested
23. Handle 23.1. Remain 23.1.1. Does not remain intact Situation Incorrect Risk Control History shows 0 failure
Trigger Intact Trigger assembly does not dimensions - OD of (s) out of 14724 devices
(Assembly) remain intact prior to patient Spring post with The OD of the spring post with spring are used in patients over a 3
Spring post/ contact, device cannot be used. loaded designed to fit the ID of the rack trigger. year (03 Jul 2014 to 03
Compression Replacement device required. compression spring Jul 2017) period.
Spring/ Rack is not compatible Design solutions employed using state of the art
Trigger Harm with the ID of the approaches which address the cause of
Device replaced Rack trigger. failure/failure mode. Such solutions relate to Simulated Use Testing
without a health features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
consequence. high degree of assurance of robust designs EVO-xx-yy-zz-D and
Impact per ref: NCT16-0036-R
No health consequence/ Implementation Ver 0
Nuisance to patient or end user DWG0316 'Rack - Trigger' EVO-xx-yy-zz-D
DWG0322 'Spring Post' products are of similar
DWG0346 'SEMS Compression Spring' design to EVO-xx-yy-zz-
C product(s) tested
1 Likely III Incorrect material - Risk Control History shows 0 failure

Trigger Assembly Material for the Trigger Assembly are Lexan and (s) out of 14724 devices
material too brittle Stainless Steel as specified by Design, have used in patients over a 3
sufficient strength to resist forces applied during year (03 Jul 2014 to 03
use. Jul 2017) period.
failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
EVO-xx-yy-zz-D
DWG0316 'Rack - Trigger' design to EVO-xx-yy-zz-
DWG0322 'Spring Post' C product(s) tested
DWG0496 'TTS HANDLE Assembly'
Trigger assembly does not dimensions - OD of (s) out of 14724 devices
remain intact during procedure, Spring post with The OD of the spring post with spring are used in patients over a 3
stent cannot be deployed. loaded designed to fit the ID of the rack trigger. year (03 Jul 2014 to 03
Replacement device required. 2 Likely IIA compression spring 1 Jul 2017) period. 1 IIA Yes No N/A
is not compatible Design solutions employed using state of the art
Harm with the ID of the approaches which address the cause of
Additional exposure to sedation, Rack trigger. failure/failure mode. Such solutions relate to Simulated Use Testing
Min
Has risk
Probability Is a
of Risk ?
?
Control
radiation and/or contrast features/ geometry/ materials which provide a has been completed for
Temporary discomfort- medical per ref: NCT16-0036-R
intervention not required Implementation Ver 0
DWG0316 'Rack - Trigger' EVO-xx-yy-zz-D
C product(s) tested
Trigger Assembly Material for the Trigger Assembly are Lexan and (s) out of 14724 devices
material too brittle Stainless Steel as specified by Design, have used in patients over a 3
sufficient strength to resist forces applied during year (03 Jul 2014 to 03
use. Jul 2017) period.
failure/failure mode. Such solutions relate to 1 EVO-xx-yy-zz-D and 1 IIA Yes No N/A
EVO-xx-yy-zz-D
23.2. Be 23.2.1. Is not graspable Situation Incorrect material - Risk Control History shows 0 failure
graspabl Trigger can not be grasped. Trigger material too (s) out of 14724 devices
e Replacement device required. soft/ ductile. Material for the Trigger is Lexan as specified by used in patients over a 3
Design, has sufficient strength to resist forces year (03 Jul 2014 to 03
Harm applied during use and is sufficient to adequately Jul 2017) period.
No harm to patient be grasped by the user.
Impact Simulated Use Testing

No health consequence/ Design solutions employed using state of the art has been completed for
Nuisance to patient or end user approaches which address the cause of EVO-xx-yy-zz-D and
1 1 III Yes No N/A
failure/failure mode. Such solutions relate to EVO-xx-yy-zz-C devices
features/ geometry/ materials which provide a per ref: NCT16-0036-R
high degree of assurance of robust designs Ver 0
DWG0316 'Rack - Trigger' C product(s) tested
DWG0322 'Spring Post'
1 Likely III
- Trigger not (s) out of 14724 devices
graspable The Trigger geometry as specified by Design has used in patients over a 3
sufficient geometry to be adequately grasped by year (03 Jul 2014 to 03
the user. Jul 2017) period.
Risk mitigated by product Design features

1 1 III Yes No N/A
Trigger can not be grasped 2 Likely IIA Trigger material too 1 (s) out of 14724 devices 1 IIA Yes No N/A
during stent deployment. Stent soft/ ductile. Material for the Trigger is Lexan as specified by used in patients over a 3
Min
Has risk
Probability Is a
of Risk ?
?
Control
deployed with difficulty. Design, has sufficient strength to resist forces year (03 Jul 2014 to 03
Prolonged procedure. applied during use and is sufficient to adequately Jul 2017) period.
be grasped by the user.
Harm
Additional exposure to sedation, Simulated Use Testing
radiation and/or contrast Design solutions employed using state of the art has been completed for
Temporary discomfort- medical features/ geometry/ materials which provide a per ref: NCT16-0036-R
intervention not required high degree of assurance of robust designs Ver 0

1 1 IIA Yes No N/A
Trigger can not be grasped to Trigger material too (s) out of 14724 devices
deploy stent fully. Partial stent soft/ ductile. Material for the Trigger is Lexan as specified by used in patients over a 3
deployment. Minor damage to Design, has sufficient strength to resist forces year (03 Jul 2014 to 03
mucosa during device and stent applied during use and is sufficient to adequately Jul 2017) period.
removal. be grasped by the user.
Harm Simulated Use Testing

Minor trauma to mucosa Design solutions employed using state of the art has been completed for
1 1 IIA Yes No N/A
Temporary discomfort- medical features/ geometry/ materials which provide a per ref: NCT16-0036-R
intervention not required high degree of assurance of robust designs Ver 0
2 Likely IIA DWG0346 'SEMS Compression Spring'

1 Simulated Use Testing 1 IIA Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
23.3. Allow 23.3.1. Does not allow smooth Situation Incorrect geometry Risk Control History shows 0 failure
smooth movement Stent deployed with difficulty : (s) out of 14724 devices
moveme ID of Handle too The Handle and trigger assembly geometry as used in patients over a 3
nt Harm small, not specified by Design ensure clearance fit year (03 Jul 2014 to 03
No harm to patient compatible with OD Jul 2017) period.
of Trigger Design solutions employed using state of the art
Impact assembly, approaches which address the cause of
No health consequence/ Insufficient failure/failure mode. Such solutions relate to Simulated Use Testing
Nuisance to patient or end user clearance features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
DWG0496 'TTS HANDLE Assembly' C product(s) tested
1 Likely III Incorrect material - Risk Control History shows 0 failure
Trigger assembly (s) out of 14724 devices
and handle Material for the Handle (Lexan), rack trigger used in patients over a 3
materials do not (Lexan), Spring post (Lexan) and Compression year (03 Jul 2014 to 03
allow for smooth spring (Stainless Steel) have smooth surfaces Jul 2017) period.
movement
1 1 III Yes No N/A
Ver 0
DWG0316 'Rack - Trigger' products are of similar
DWG0322 'Spring Post' design to EVO-xx-yy-zz-
DWG0346 'SEMS Compression Spring' C product(s) tested
Situation Incorrect geometry Risk Control History shows 0 failure
Stent cannot be deployed. : (s) out of 14724 devices
Replacement device required. ID of Handle too The Handle and trigger assembly geometry as used in patients over a 3
Prolonged procedure small, not specified by Design ensure clearance fit year (03 Jul 2014 to 03
compatible with OD Jul 2017) period.
Harm of Trigger Design solutions employed using state of the art
Additional exposure to sedation, assembly, approaches which address the cause of
radiation and/or contrast Insufficient failure/failure mode. Such solutions relate to Simulated Use Testing
clearance features/ geometry/ materials which provide a 1 has been completed for 1 IIA Yes No N/A
Temporary discomfort- medical established effective through clinical use. EVO-xx-yy-zz-C devices
intervention not required per ref: NCT16-0036-R
2 Likely IIA DWG0496 'TTS HANDLE Assembly' C product(s) tested
Trigger assembly (s) out of 14724 devices
and handle Material for the Handle (Lexan), rack trigger used in patients over a 3
materials do not (Lexan), Spring post (Lexan) and Compression year (03 Jul 2014 to 03
allow for smooth spring (Stainless Steel) have smooth surfaces Jul 2017) period.
movement
approaches which address the cause of 1 Simulated Use Testing 1 IIA Yes No N/A
Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
DWG0316 'Rack - Trigger' products are of similar
DWG0322 'Spring Post' design to EVO-xx-yy-zz-
DWG0346 'SEMS Compression Spring' C product(s) tested
23.4. Engage 23.4.1. Drive gear is not engaged during Situation Incorrect geometry Risk Control History shows 0 failure
trigger use The device cannot be used. :Gear teeth on the The Handle and trigger assembly geometry as (s) out of 14724 devices
drive replacement device required. trigger do not align specified by Design ensure alignment and used in patients over a 3
gear with teeth of drive compatibility. year (03 Jul 2014 to 03
Harm gear Jul 2017) period.
Device replaced Design solutions employed using state of the art
without a health approaches which address the cause of
consequence. failure/failure mode. Such solutions relate to Simulated Use Testing
1 Likely III features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
No health consequence/ established effective through clinical use. EVO-xx-yy-zz-C devices
Nuisance to patient or end user per ref: NCT16-0036-R
Drive gear is partially engaged, :Gear teeth on the The Handle and trigger assembly geometry as (s) out of 14724 devices
slipping occurs. Stent deployed trigger do not align specified by Design ensure alignment and used in patients over a 3
with difficulty. with teeth of drive compatibility. year (03 Jul 2014 to 03
gear Jul 2017) period.
Additional exposure to sedation, approaches which address the cause of
radiation and/or contrast failure/failure mode. Such solutions relate to Simulated Use Testing
2 Likely IIA features/ geometry/ materials which provide a 1 has been completed for 1 IIA Yes No N/A
23.5. Reset 23.5.1. Trigger does not return to Situation Incorrect geometry Risk Control History shows 0 failure
under neutral position Stent cannot be deployed. : Insufficient The Handle and trigger assembly geometry as (s) out of 14724 devices
spring Replacement device required. clearance between specified by Design ensure clearance and used in patients over a 3
load the handle and compatibility. year (03 Jul 2014 to 03
Harm trigger assembly to Jul 2017) period.
No harm to patient return to neutral Design solutions employed using state of the art
position. approaches which address the cause of
Impact failure/failure mode. Such solutions relate to Simulated Use Testing
No health consequence/ features/ geometry/ materials which provide a has been completed for
1 1 III Yes No N/A
Nuisance to patient or end user high degree of assurance of robust designs EVO-xx-yy-zz-D and
1 Likely III DWG0497 'TTS SEMS Assembly'
insufficient The Compression spring material (stainless steel) (s) out of 14724 devices
resistance in the is selected to provide appropriate resistance to used in patients over a 3
spring to return the the trigger movement year (03 Jul 2014 to 03
trigger to neutral Jul 2017) period.
position. Design solutions employed using state of the art
failure/failure mode. Such solutions relate to 1 Simulated Use Testing 1 III Yes No N/A
Min
Has risk
Probability Is a
of Risk ?
?
Control
Trigger is manually returned to : Insufficient The Handle and trigger assembly geometry as (s) out of 14724 devices
neutral position each time, clearance between specified by Design ensure clearance and used in patients over a 3
difficulty in deploying stent. the handle and compatibility. year (03 Jul 2014 to 03
trigger assembly to Jul 2017) period.
Harm return to neutral Design solutions employed using state of the art
Additional exposure to sedation, position. approaches which address the cause of
radiation and/or contrast failure/failure mode. Such solutions relate to Simulated Use Testing
1 1 IIA Yes No N/A
2 Likely IIA
insufficient The Compression spring material (stainless steel) (s) out of 14724 devices
resistance in the is selected to provide appropriate resistance to used in patients over a 3
spring to return the the trigger movement year (03 Jul 2014 to 03
trigger to neutral Jul 2017) period.
position. Design solutions employed using state of the art
1 1 IIA Yes No N/A
23.6. Should 23.6.1. The assembly does not provide Situation Incorrect Geometry Risk Control History shows 0 failure
provide sufficient mechanical leverage The Stent cannot be deployed - gearing ratio (s) out of 14724 devices
enough for ease of use easily by either a male or female. requires excessive Gearing ratio's as specified by design ensure that used in patients over a 3
mechani Device replaced force to activate deployment forces are not excessive. year (03 Jul 2014 to 03
cal deployment Jul 2017) period.
leverage Harm Design solutions employed using state of the art
to allow Device replaced approaches which address the cause of
the Stent without a health failure/failure mode. Such solutions relate to Simulated Use Testing
to be consequence. 1 Likely III features/ geometry/ materials which provide a 1 has been completed for 1 III Yes No N/A
deployed high degree of assurance of robust designs EVO-xx-yy-zz-D and
by both Impact established effective through clinical use. EVO-xx-yy-zz-C devices
Male and No health consequence/ per ref: NCT16-0036-R
Female Nuisance to patient or end user Implementation Ver 0
users DWG0497 'TTS SEMS Assembly' EVO-xx-yy-zz-D
C product(s) tested
23.7. The 23.7.1. The assembly does not Situation Incorrect material - Risk Control History shows 0 failure
assembl withstand loading applied in The trigger assembly cannot insufficient column Material for the Trigger Assembly (Lexan, (s) out of 14724 devices
y must both forward and reverse withstand load in either direction strength Stainless Steel) and material for handle used in patients over a 3
withstan directions and fails. Device replaced (Polycarbonate/ABS) as specified by Design, year (03 Jul 2014 to 03
d loading these provide sufficient column strength and Jul 2017) period.
applied Harm withstand forces applied during use.
in both No harm to patient
the 1 Likely III Design solutions employed using state of the art 1 Simulated Use Testing 1 III Yes No N/A
forward Impact approaches which address the cause of has been completed for
and No health consequence/ failure/failure mode. Such solutions relate to EVO-xx-yy-zz-D and
reverse Nuisance to patient or end user features/ geometry/ materials which provide a EVO-xx-yy-zz-C devices
direction high degree of assurance of robust designs per ref: NCT16-0036-R
s established effective through clinical use. Ver 0
EVO-xx-yy-zz-D
Min
Has risk
Probability Is a
of Risk ?
?
Control
24. Handle 24.1. Allow 24.1.1. Does not provide a smooth Situation Incorrect geometry Risk Control History shows 0 failure
(Belt smooth movement Stent cannot be deployed or - Belt Assembly; The Belt Assembly; Optibelt Drive Belt, RMN (s) out of 14724 devices
Assembly); moveme recaptured by sheath. Optibelt Drive Belt, Drive Pulley Stabiliser, Belt Pulley, Idler Pin, Cam used in patients over a 3
Optibelt Drive nt Replacement device required. RMN Drive Pulley Roller geometries as specified by design have an year (03 Jul 2014 to 03
Belt, RMN between Prolonged procedure Stabiliser, Belt adequate fit to each other Jul 2017) period.
Drive Pulley all listed Pulley, Idler Pin,
Stabiliser, Belt compone Harm Cam Roller have Design solutions employed using state of the art
Pulley, Idler nts Additional exposure to sedation, loose fit with each approaches which address the cause of Simulated Use Testing
Pin, Cam radiation and/or contrast other failure/failure mode. Such solutions relate to has been completed for
Roller) features/ geometry/ materials which provide a EVO-xx-yy-zz-D and
1 1 IIA Yes No N/A
DWG0312 'CAM ROLLER' products are of similar
DWG0328 'IDLER PIN' design to EVO-xx-yy-zz-
DWG0311 'Belt Pulleys (Front and Back)' C product(s) tested
DWG0417 'Drive Pulley Fix'
RMS0093 'OPTIBELT DRIVE BELTS 77ST'
Belt Assembly; The Belt Assembly; Optibelt Drive Belt (s) out of 14724 devices
Optibelt Drive Belt, (Polychloropren/Glass cord/polyimide) , RMN used in patients over a 3
RMN Drive Pulley Drive Pulley Stabiliser(Aluminium), Belt Pulley year (03 Jul 2014 to 03
Stabiliser, Belt (Delrin), Idler Pin (Stainless Steel), Cam Roller Jul 2017) period.
Pulley, Idler Pin, (Delrin) material characteristics as specified by
Cam Roller is too design have sufficient strength to resist forces
brittle applied to them Simulated Use Testing
Design solutions employed using state of the art EVO-xx-yy-zz-D and
failure/failure mode. Such solutions relate to 1 per ref: NCT16-0036-R 1 IIA Yes No N/A
2 Likely IIA
features/ geometry/ materials which provide a Ver 0
high degree of assurance of robust designs EVO-xx-yy-zz-D
Implementation C product(s) tested
DWG0312 'CAM ROLLER'
DWG0328 'IDLER PIN'
DWG0311 'Belt Pulleys (Front and Back)'
dimensions - Belt Belt Assembly; Optibelt Drive Belt, RMN Drive (s) out of 14724 devices
Assembly; Optibelt Pulley Stabiliser, Belt Pulley, Idler Pin, Cam Roller used in patients over a 3
Drive Belt, RMN dimensions as specified by design are year (03 Jul 2014 to 03
Drive Pulley appropriately sized to resist forces applied to Jul 2017) period.
Stabiliser, Belt them
Pulley, Idler Pin,
Cam Roller Design solutions employed using state of the art Simulated Use Testing
features/ geometry/ materials which provide a 1 EVO-xx-yy-zz-C devices 1 IIA Yes No N/A
EVO-xx-yy-zz-D
DWG0312 'CAM ROLLER' design to EVO-xx-yy-zz-
DWG0328 'IDLER PIN' C product(s) tested
DWG0311 'Belt Pulleys (Front and Back)'
24.2. Compon 24.2.1. Components do not remain Situation Incorrect Risk Control History shows 0 failure
ents intact and assembled Difficulty in deploying or 2 Likely IIA dimensions - The dimensions of the components as specified 1 (s) out of 14724 devices 1 IIA Yes No N/A
must recapturing stent. Replacement components are by design, are compatible for purpose used in patients over a 3
Min
Has risk
Probability Is a
of Risk ?
?
Control
remain device required not compatible year (03 Jul 2014 to 03
intact Design solutions employed using state of the art Jul 2017) period.
Additional exposure to sedation, failure/failure mode. Such solutions relate to
radiation and/or contrast features/ geometry/ materials which provide a Simulated Use Testing
Impact established effective through clinical use. EVO-xx-yy-zz-D and
Temporary discomfort- medical EVO-xx-yy-zz-C devices
intervention not required Implementation per ref: NCT16-0036-R
DWG0312 'CAM ROLLER' Ver 0
DWG0328 'IDLER PIN' EVO-xx-yy-zz-D
DWG0311 'Belt Pulleys (Front and Back)' products are of similar
DWG0417 'Drive Pulley Fix' design to EVO-xx-yy-zz-
RMS0093 'OPTIBELT DRIVE BELTS 77ST' C product(s) tested
DWG0496 'TTS HANDLE Assembly' Design verification of
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
insufficient column Material for the components, Cam Roller (Acetal), (s) out of 14724 devices
strength Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley used in patients over a 3
Fix(Aluminium), Optibelt Drive Belt year (03 Jul 2014 to 03
(Polychloroprene/Glass cord/polyimide), as Jul 2017) period.
specified by design provides sufficient column
strength and can withstand forces applied during
use Simulated Use Testing
failure/failure mode. Such solutions relate to per ref: NCT16-0036-R
DWG0312 'CAM ROLLER' Design verification of
DWG0328 'IDLER PIN' Evolution Handle
DWG0311 'Belt Pulleys (Front and Back)' components from
DWG0417 'Drive Pulley Fix' production moulds has
RMS0093 'OPTIBELT DRIVE BELTS 77ST' been completed for
DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Difficulty in deploying or dimensions - The dimensions of the components as specified (s) out of 14724 devices
recapturing stent. Replacement components are by design, are compatible for purpose used in patients over a 3
device required not compatible year (03 Jul 2014 to 03
Device replaced failure/failure mode. Such solutions relate to
without a health 1 Likely III features/ geometry/ materials which provide a 1 Simulated Use Testing 1 III Yes No N/A
consequence. high degree of assurance of robust designs has been completed for
Nuisance to patient or end user DWG0312 'CAM ROLLER' Ver 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
DWG0417 'Drive Pulley Fix' design to EVO-xx-yy-zz-
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
insufficient column Material for the components, Cam Roller (Acetal), (s) out of 14724 devices
strength Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley used in patients over a 3
Fix(Aluminium), Optibelt Drive Belt year (03 Jul 2014 to 03
specified by design provides sufficient column
strength and can withstand forces applied during
use Simulated Use Testing
failure/failure mode. Such solutions relate to per ref: NCT16-0036-R
per ref: VAL08-0058
REPORT Rev 0
tested
24.3. Transfer 24.3.1. Does not transfer rotational Situation Incorrect material - Risk Control History shows 0 failure
of forces adequately Difficulty in deploying or insufficient column Material for the components, Cam Roller (Acetal), (s) out of 14724 devices
rotational recapturing stent. Replacement strength Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley used in patients over a 3
forces to device required Fix(Aluminium), Optibelt Drive Belt year (03 Jul 2014 to 03
linear (Polychloroprene/Glass cord/polyimide), as Jul 2017) period.
motion Harm specified by design provides sufficient column
Additional exposure to sedation, strength and can withstand forces applied during
radiation and/or contrast use Simulated Use Testing
Impact Design solutions employed using state of the art EVO-xx-yy-zz-D and
Temporary discomfort- medical approaches which address the cause of EVO-xx-yy-zz-C devices
intervention not required failure/failure mode. Such solutions relate to per ref: NCT16-0036-R
2 Likely IIA features/ geometry/ materials which provide a 1 Ver 0 1 IIA Yes No N/A
per ref: VAL08-0058
Min
Has risk
Probability Is a
of Risk ?
?
Control
REPORT Rev 0
tested
dimensions - The dimensions of the components as specified (s) out of 14724 devices
components are by design, are compatible for purpose used in patients over a 3
not compatible year (03 Jul 2014 to 03
features/ geometry/ materials which provide a Simulated Use Testing
Implementation per ref: NCT16-0036-R
DWG0417 'Drive Pulley Fix' 1 design to EVO-xx-yy-zz- 1 IIA Yes No N/A
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Incorrect materials Risk Control Simulated Use Testing
- Materials are not Material for the components, Cam Roller (Acetal), has been completed for
suitable for Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley EVO-xx-yy-zz-D and
purpose Fix(Aluminium), Optibelt Drive Belt EVO-xx-yy-zz-C devices
(Polychloroprene/Glass cord/polyimide), as per ref: NCT16-0036-R
specified by design provides sufficient column Ver 0
strength and can withstand forces applied during EVO-xx-yy-zz-D
use products are of similar
Potential Cause of failure addressed design to EVO-xx-yy-zz-
C product(s) tested
Implementation Design verification of
DWG0312 'CAM ROLLER' Evolution Handle
1 1 IIA Yes No N/A
DWG0328 'IDLER PIN' components from
DWG0311 'Belt Pulleys (Front and Back)' production moulds has
DWG0417 'Drive Pulley Fix' been completed for
RMS0093 'OPTIBELT DRIVE BELTS 77ST' EVO-xx-yy-zz-D and
DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-C devices
per ref: VAL08-0058
REPORT Rev 0
tested
Difficulty in deploying or insufficient column Material for the components, Cam Roller (Acetal), (s) out of 14724 devices
recapturing stent. Replacement strength Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley used in patients over a 3
device required Fix(Aluminium), Optibelt Drive Belt year (03 Jul 2014 to 03
Harm 1 Likely III specified by design provides sufficient column 1 1 III Yes No N/A
Device replaced strength and can withstand forces applied during
without a health use Simulated Use Testing
consequence. has been completed for
Impact approaches which address the cause of EVO-xx-yy-zz-C devices
Min
Has risk
Probability Is a
of Risk ?
?
Control
No health consequence/ failure/failure mode. Such solutions relate to per ref: NCT16-0036-R
Nuisance to patient or end user features/ geometry/ materials which provide a Ver 0
per ref: VAL08-0058
REPORT Rev 0
tested
dimensions - The dimensions of the components as specified (s) out of 14724 devices
components are by design, are compatible for purpose used in patients over a 3
not compatible year (03 Jul 2014 to 03
features/ geometry/ materials which provide a Simulated Use Testing
Implementation per ref: NCT16-0036-R
DWG0417 'Drive Pulley Fix' 1 design to EVO-xx-yy-zz- 1 III Yes No N/A
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
Incorrect materials Risk Control Simulated Use Testing
- Materials are not Material for the components, Cam Roller (Acetal), has been completed for
suitable for Idler Pin (S/S), Belt Pulleys (Acetal), Drive Pulley EVO-xx-yy-zz-D and
purpose Fix(Aluminium), Optibelt Drive Belt EVO-xx-yy-zz-C devices
(Polychloroprene/Glass cord/polyimide), as per ref: NCT16-0036-R
specified by design provides sufficient column Ver 0
strength and can withstand forces applied during EVO-xx-yy-zz-D
use products are of similar
Potential Cause of failure addressed design to EVO-xx-yy-zz-
C product(s) tested
Implementation Design verification of
DWG0312 'CAM ROLLER' 1 Evolution Handle 1 III Yes No N/A
DWG0328 'IDLER PIN' components from
DWG0311 'Belt Pulleys (Front and Back)' production moulds has
DWG0417 'Drive Pulley Fix' been completed for
RMS0093 'OPTIBELT DRIVE BELTS 77ST' EVO-xx-yy-zz-D and
DWG0496 'TTS HANDLE Assembly' EVO-xx-yy-zz-C devices
per ref: VAL08-0058
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
25. Handle 25.1. Items 25.1.1. The assembly does not remain Situation Incorrect Risk Control Simulated Use Testing
(Driveshaft within intact The stent is neither able to be dimensions - The geometry of the components are specified by has been completed for
Assembly) - the deployed or recaptured. Device Geometry of the design so that they are compatible with each EVO-xx-yy-zz-D and
Gear 3 (Right assembl replaced components are other EVO-xx-yy-zz-C devices
Drive Gear) + y to incompatible Potential Cause of failure addressed per ref: NCT16-0036-R
Gear 6 remain Harm Ver 0
(Trigger Drive intact No harm to patient Implementation EVO-xx-yy-zz-D
Gear) + Gear DWG0306 'GEAR 3 (RIGHT DRIVE GEAR)' products are of similar
1 ( Left Drive Impact DWG0309 'GEAR 6 (TRIGGER DRIVE GEAR)' design to EVO-xx-yy-zz-
Gear) + Drive No health consequence/ DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' C product(s) tested
gear shaft + Nuisance to patient or end user DWG0327 'DRIVE SHAFT' Design verification of
Roller Clutch Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
25.2. Allow for 25.2.1. Difficulty in advancing or Situation Incorrect Materials Risk Control Simulated Use Testing
smooth recapturing outer sheath The stent is neither able to be - Materials do not Gear Material and drive shaft material as has been completed for
moveme deployed or recaptured. Device allow for smooth specified by design allow for the smooth EVO-xx-yy-zz-D and
nt replaced movement between movement between components EVO-xx-yy-zz-C devices
between components Potential Cause of failure addressed per ref: NCT16-0036-R
the parts Harm Ver 0
No harm to patient Implementation EVO-xx-yy-zz-D
DWG0306 'GEAR 3 (RIGHT DRIVE GEAR)' products are of similar
Impact DWG0309 'GEAR 6 (TRIGGER DRIVE GEAR)' design to EVO-xx-yy-zz-
No health consequence/ DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' C product(s) tested
Nuisance to patient or end user DWG0327 'DRIVE SHAFT' Design verification of
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
25.3. Provide 25.3.1. Does not stop gears from Situation Incorrect Risk Control Simulated Use Testing
unidirecti rotating in both directions The stent is neither able to be dimensions - Component geometry as specified by design are has been completed for
onal deployed or recaptured due to Geometry of compatible to provide uni-directional movement EVO-xx-yy-zz-D and
rotation gears not being locked to the one components are Potential Cause of failure addressed EVO-xx-yy-zz-C devices
to either direction. Device replaced not compatible per ref: NCT16-0036-R
deploym Implementation Ver 0
ent or Harm DWG0306 'GEAR 3 (RIGHT DRIVE GEAR)' EVO-xx-yy-zz-D
recaptur No harm to patient or end user DWG0309 'GEAR 6 (TRIGGER DRIVE GEAR)' products are of similar
e DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' design to EVO-xx-yy-zz-
Impact DWG0327 'DRIVE SHAFT' C product(s) tested
No health consequence/ Design verification of
Nuisance to patient or end user 1 Likely III 1 Evolution Handle 1 III Yes No N/A
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
Incorrect Materials Risk Control Simulated Use Testing
- Materials are of Gear Material Delrin as specified by design has has been completed for
insufficient column sufficient strength to resist applicable forces EVO-xx-yy-zz-D and
strength applied during use EVO-xx-yy-zz-C devices
Potential Cause of failure eliminated per ref: NCT16-0036-R
Ver 0
DWG0306 'GEAR 3 (RIGHT DRIVE GEAR)' products are of similar
DWG0309 'GEAR 6 (TRIGGER DRIVE GEAR)' design to EVO-xx-yy-zz-
DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' C product(s) tested
DWG0327 'DRIVE SHAFT' Design verification of
Evolution Handle
1 1 III Yes No N/A
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
26. Handle 26.1. Assembl 26.1.1. Components do not remain Situation Incorrect Risk Control Simulated Use Testing
(Pulley shaft y intact. Incapable to transfer movement dimensions - The geometry of the components are specified by has been completed for
Assembly) - compone from (drive shaft Gear 3)/gear 4 Geometry of the design so that they are compatible with each EVO-xx-yy-zz-D and
Directional nts must to recapture/deploy stent. components are other EVO-xx-yy-zz-C devices
Switch + Gear remain Replacement of device is incompatible Potential Cause of failure addressed per ref: NCT16-0036-R
2 ( Left Pulley intact. required. Ver 0
Gear) + Drive Implementation EVO-xx-yy-zz-D
Pulley + Gear Harm DWG0305 'Gear 2 (For Pulley Gear)' products are of similar
5 ( Right No harm to patient DWG0308 'Gear 5 (Rev Pulley Gear)' design to EVO-xx-yy-zz-
Pulley Gear) + DWG0310 'DRIVE PULLEY' C product(s) tested
Pulley Shaft + Impact DWG0317 'DIRECTION SWITCH' Design verification of
Roller Clutch No health consequence/ DWG0326 'PULLEY SHAFT' Evolution Handle
1 1 III Yes No N/A
Nuisance to patient or end user components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
1 Likely III tested
Incorrect Materials Risk Control Simulated Use Testing
- Materials do not Gear Material Delrin and Pulley shaft material 304 has been completed for
allow for smooth S/S as specified by design allow for the smooth EVO-xx-yy-zz-D and
movement between movement between components EVO-xx-yy-zz-C devices
components Potential Cause of failure addressed per ref: NCT16-0036-R
Ver 0
DWG0305 'Gear 2 (For Pulley Gear)' products are of similar
DWG0308 'Gear 5 (Rev Pulley Gear)' design to EVO-xx-yy-zz-
DWG0310 'DRIVE PULLEY' C product(s) tested
DWG0317 'DIRECTION SWITCH' Design verification of
DWG0326 'PULLEY SHAFT' 1 Evolution Handle 1 III Yes No N/A
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
26.2. Allow 26.2.1. Difficult in deployment or Situation Incorrect Risk Control History shows 0 failure
smooth recapture of stent. Difficulty in transfer movement dimensions - The geometry of the components are specified by (s) out of 14724 devices
moveme from drive shaft assembly to the Geometry of the design so that they are compatible with each used in patients over a 3
nt recapturing/deployment of the components are other year (03 Jul 2014 to 03
stent. Replacement of device is incompatible Jul 2017) period.
required. Design solutions employed using state of the art
Harm failure/failure mode. Such solutions relate to Simulated Use Testing
No harm to patient features/ geometry/ materials which provide a has been completed for
1 1 III Yes No N/A
No health consequence/ per ref: NCT16-0036-R
Nuisance to patient or end user Implementation Ver 0
DWG0305 'Gear 2 (For Pulley Gear)' EVO-xx-yy-zz-D
DWG0308 'Gear 5 (Rev Pulley Gear)' products are of similar
DWG0310 'DRIVE PULLEY' design to EVO-xx-yy-zz-
DWG0317 'DIRECTION SWITCH' C product(s) tested
DWG0326 'PULLEY SHAFT'
Incorrect Materials Risk Control History shows 0 failure
- Materials do not Gear Material and Pulley shaft material as (s) out of 14724 devices
allow for smooth specified by design allow for the smooth used in patients over a 3
movement between movement between components year (03 Jul 2014 to 03
components Jul 2017) period.
1 1 III Yes No N/A
1 Likely III
method: The handle assembly is a fit as specified by (s) out of 14724 devices
Insufficient Design, which provides sufficient strength to used in patients over a 3
assembly strength withstand forces applied during use year (03 Jul 2014 to 03
Jul 2017) period.
1 1 III Yes No N/A
26.3. Facilitate 26.3.1. Difficulty in push direction button Situation Incorrect Risk Control History shows 0 failure
direction to opposite side. Physician/Assistant unable to dimensions - The geometry of the components are specified by (s) out of 14724 devices
al switch change Drive pulley direction if Geometry of the design so that they are compatible with each used in patients over a 3
necessary. Replacement device components are other year (03 Jul 2014 to 03
is required. incompatible Jul 2017) period.
Harm 1 Likely III approaches which address the cause of 1 1 III Yes No N/A
No harm to patient failure/failure mode. Such solutions relate to Simulated Use Testing
No health consequence/ established effective through clinical use. EVO-xx-yy-zz-C devices
Nuisance to patient or end user per ref: NCT16-0036-R
Min
Has risk
Probability Is a
of Risk ?
?
Control
- Materials do not Gear Material and Pulley shaft material as (s) out of 14724 devices
allow for smooth specified by design allow for the appropriate force used in patients over a 3
movement between components year (03 Jul 2014 to 03
high degree of assurance of robust designs 1 EVO-xx-yy-zz-D and 1 III Yes No N/A
26.4. Be 26.4.1. Cannot be grasped. Situation Incorrect Risk Control History shows 0 failure
graspabl Unable to switch Drive pulley dimensions - The geometry of the components are specified by (s) out of 14724 devices
e direction between deployment Geometry of the design to be adequately grasped by the user. used in patients over a 3
and recapture. Replacement of components are year (03 Jul 2014 to 03
device is required. not graspable Design solutions employed using state of the art Jul 2017) period.
No harm to patient features/ geometry/ materials which provide a Simulated Use Testing
Impact established effective through clinical use. EVO-xx-yy-zz-D and
No health consequence/ EVO-xx-yy-zz-C devices
Nuisance to patient or end user Implementation per ref: NCT16-0036-R
DWG0317 'Direction Switch' Ver 0
EVO-xx-yy-zz-D
1 Likely III 1 design to EVO-xx-yy-zz- 1 III Yes No N/A
C product(s) tested
Evolution Handle
components from
been completed for
EVO-xx-yy-zz-D and
per ref: VAL08-0058
REPORT Rev 0
tested
26.5. Be 26.5.1. Switch button is not Situation Incorrect Risk Control History shows 0 failure
distingui distinguishable. Unable to switch Drive pulley dimension - The geometry of the components are specified by (s) out of 14724 devices
shable direction. Replacement of device Geometry of switch design guarantee protrusion of switch button on used in patients over a 3
is required. button does not the side of handle. year (03 Jul 2014 to 03
protrude on the Jul 2017) period.
Harm side of handle. Design solutions employed using state of the art
No harm to patient approaches which address the cause of Design verification of
Impact 1 Likely III features/ geometry/ materials which provide a 1 components from 1 III Yes No N/A
No health consequence/ high degree of assurance of robust designs production moulds has
Nuisance to patient or end user established effective through clinical use. been completed for
EVO-xx-yy-zz-D and
DWG0317 'Direction Switch' per ref: VAL08-0058
Min
Has risk
Probability Is a
of Risk ?
?
Control
tested
Switch button does The switch button has a contrast colour as (s) out of 14724 devices
not distinguish from specified by designer distinguish from handle used in patients over a 3
handle colour. year (03 Jul 2014 to 03
Jul 2017) period.
1 1 III Yes No N/A
EVO-xx-yy-zz-D and
DWG0317 'Direction Switch' per ref: VAL08-0058
tested
27. Handle 27.1. Allow 27.1.1. Components do not move easily Situation Incorrect Materials Risk Control History shows 0 failure
(Interaction) - smooth Difficulty in the deployment of the - Geometry of the The geometry of the components are specified by (s) out of 14724 devices
Left Side moveme stent when in the desired components are design so that they are compatible with each used in patients over a 3
(deployment) nt location. Device replaced incompatible other year (03 Jul 2014 to 03
Gear 1 ( Left between Jul 2017) period.
Drive Gear) + compone Harm Design solutions employed using state of the art
Gear 6 ( nts No harm to patient approaches which address the cause of
Trigger Drive failure/failure mode. Such solutions relate to Design verification of
Gear) + Drive Impact features/ geometry/ materials which provide a Evolution Handle
shaft + No health consequence/ high degree of assurance of robust designs components from
Directional Nuisance to patient or end user established effective through clinical use. production moulds has
Switch + Gear been completed for
5 ( Right Implementation EVO-xx-yy-zz-D and
Pulley Gear) + DWG0317 'DIRECTION SWITCH' EVO-xx-yy-zz-C devices
Drive Pulley + DWG0310 'DRIVE PULLEY' per ref: VAL08-0058
Drive Pulley DWG0308 'Gear 5 (Rev Pulley Gear)' 1 REPORT Rev 0 1 III Yes No N/A
Shaft DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' EVO-xx-yy-zz-C & EVO-
DWG0309 'GEAR 6 (TRIGGER DRIVE GEAR)' xx-yy-zz-D products are
DWG0326 'PULLEY SHAFT' of similar design to EVO-
DWG0327 'DRIVE SHAFT' xx-yy-zz-E product(s)
DWG0497 'TTS SEMS Assembly' tested
EVO-xx-yy-zz-D and
1 Likely III EVO-xx-yy-zz-C devices
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
- Materials do not Gear Material and drive shaft material as (s) out of 14724 devices
features/ geometry/ materials which provide a 1 Evolution Handle 1 III Yes No N/A
been completed for
DWG0317 'DIRECTION SWITCH' EVO-xx-yy-zz-C devices
DWG0310 'DRIVE PULLEY' per ref: VAL08-0058
DWG0308 'Gear 5 (Rev Pulley Gear)' REPORT Rev 0
DWG0304 'GEAR 1 (LEFT DRIVE GEAR)' EVO-xx-yy-zz-C & EVO-
Min
Has risk
Probability Is a
of Risk ?
?
Control
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
C product(s) tested
Situation Incorrect Materials Risk Control History shows 0 failure
Difficulty in deployment of stent. - Geometry of the The geometry of the components are specified by (s) out of 14724 devices
Sudden forward movement components are design so that they are compatible with each used in patients over a 3
incompatible other year (03 Jul 2014 to 03
Minor trauma to mucosa Design solutions employed using state of the art
Impact failure/failure mode. Such solutions relate to Design verification of
Temporary discomfort- medical features/ geometry/ materials which provide a Evolution Handle
intervention not required high degree of assurance of robust designs components from
been completed for
DWG0310 'DRIVE PULLEY' per ref: VAL08-0058
DWG0308 'Gear 5 (Rev Pulley Gear)' 1 REPORT Rev 0 1 IIA Yes No N/A
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
2 Likely IIA
C product(s) tested
- Materials do not Gear Material and drive shaft material as (s) out of 14724 devices
been completed for
DWG0310 'DRIVE PULLEY' 1 per ref: VAL08-0058 1 IIA Yes No N/A
DWG0308 'Gear 5 (Rev Pulley Gear)' REPORT Rev 0
EVO-xx-yy-zz-D and
Ver 0
EVO-xx-yy-zz-D
Min
Has risk
Probability Is a
of Risk

G5-Evolution® Colonic Stent System-Uncovered

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G5-Evolution® Colonic Stent System-Uncovered

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EVOLUTION® COLONIC STENT

Elaboración de Dossier Técnico para el

Docente: Elizabeth Valencia A. aquí

Inscripción en el Registro Sanitario de N° DE EXPEDIENTE:

2. RAZÓN SOCIAL 3. NOMBRE COMERCIAL 4. R.U.C. Nº

CORPORACION FARMACEUTICA INTEGRAL S.A.C. CORFARINT 20604270300

5. UBICACIÓN Av./ Calle / Jr. 6. Nº/Mz/Lt 7. REFERENCIA

LOS PETROLEROS 170

8. URBANIZACIÓN 9. DISTRITO 10. PROVINCIA

LOS INGENIEROS LA MOLINA LIMA

LIMA PERU 980562483 direccion.tecnica@corfarint.com.pe

16. DIRECTOR TECNICO 17. REPRESENTANTE LEGAL

ROXANA ARAUCO MARIN SILVA TORRES MARCO ANTONIO

II. INFORMACIÓN DEL DISPOSITIVO MEDICO:

19. NOMBRE DEL DISPOSITIVO MÉDICO

EVOLUTION® COLONIC STENT SYSTEM UNCOVERED

20. Marca Comercial (si tuviera)

21. Nomenclatura universal (nombre común o

22. Código de Identificación (según el estándar

23. Estándar internacional utilizado GMDN

24. Origen: Nacional ( ) Extranjero ( X )

III. INFORMACIÓN DEL FABRICANTE:

28. País IRLANDA

29. Cuenta con BPM vigente emitido por la ANM SI N° de BPM NO X

30. Sitio de Fabricación IRLANDA

33. Fabricación por Encargo:

Dirección del Fabricante: País:

Dirección del Fabricante: País:

34. Fabricación por Etapas:

LIMA, 16 DE SETIEMBRE DEL 2022.

c. Clasificación del DM según nivel de

e. Marca Comercial (si

f. Nomenclatura universal (nombre STENT COLÓNICO g. Código de identificación h. Estándar internacional

j. Fabricante COOK IRELAND LIMITED k. País de fabricación IRLANDA

ll. Otras modalidades Acondicionado Ensamblado Envasado

-Stent metálico autoexpandible, con longitud de

-Stent metálico autoexpandible, con longitud de

-Stent metálico autoexpandible, con longitud de

Emitido a: Cook lreland Limited O'Halloran Road

Fecha de caducidad: 27 de mayo de 2025.

CFS 11464 3/19

To: Health Authorities in Peru

We: Cook Ireland Limited

Re: Letter of Manufacturer

Please see below for the following details:

GMDN 1 /NBOG2 Codes

Product Nomenclature System Code Term

Product Name Global Product

Talita Feitosa da Silva

30 de abril del 2021

Re: Carta del fabricante

Códigos GMDN1 /NBOG2

Familia de Sistema de Código Término

Evolution® GMDN - Código inicial 36227 Stent esofágico

Código GMDN - Actual 61751 Stent esofágico polimérico-

NBOG MD0101 Dispositivos no activos para

Evolution® GMDN - Código inicial 37847 Stent colónico sin recubrimiento

NBOG MD0101 Dispositivos no activos para

Este producto tiene un código GMDN 36227 y término: Stent esofágico.

Número de Pieza Nombre del producto Número Global del

Le agradeceremos que tenga en cuenta esta información durante el proceso de evaluación

Talita Feitosa da Silva

Holder of Certificate: Cook Ireland Limited