Edwards SAPIEN 3 Instrucciones De Uso página 7

Substance
Polyethylene
Iron
Titanium
Manganese
Silicon
Titanium dioxide
Polybutilate
Carbon
Antimony trioxide
Boron
Phosphorus
Sulfur
D&C Green No. 6
Silicon dioxide
Erucamide
4-Dodecylbenzenesulfonic
acid
12.0 Summary of Safety and Clinical Performance
(SSCP)
The SSCP has been adapted in accordance with the clinical evaluation
assessment by the Notified Body on which CE certification has been
granted. The SSCP contains a relevant summary of the same information.
The Notified Body has taken notice of and agreed with the benefit-risk
rationales for the short- and long-term safety and effectiveness of the
SAPIEN 3 platform.
Conformity with the entire SAPIEN 3 platform of the Performance
Requirements (GSPR) for safety (MDR GSPR1), performance (MDR GSPR1),
acceptability of side-effects (MDR GSPR8), usability (MDR GSPR5), device
lifetime (MDR GSPR6), and acceptable benefit-risk profile (MDR GSPR8)
has been established for the labelled indications.
Refer to https://meddeviceinfo.edwards.com/ for a SSCP for this medical
device.
After the launch of the European Database on Medical Devices/Eudamed,
refer to https://ec.europa.eu/tools/eudamed for a SSCP for this medical
device.
13.0 Basic Unique Device Identification-Device
Identifier (UDI-DI)
The Basic UDI-DI is the access key for device-related information entered
in the Eudamed. The Basic UDI-DI for the valves, delivery system and
sheath can be used to locate the SSCP.
The following table contains the Basic UDI-DI:
20 mm 23 mm
Product System System
Edwards
SAPIEN 3 9600TFX 9600TFX
Transcatheter (20 mm) (23 mm)
Heart Valve
Edwards
COMMANDER 9610TF20 9610TF23 9610TF26 9610TF29 0690103D00
Delivery
System
CAS Model Mass Range
(mg)
9002-88-4 14.2 - 19.7
7439-89-6 0 - 10.9
7440-32-6 0 - 10.9
7439-96-5 0 - 1.64
7440-21-3 0 - 1.64
13463-67-7 0.219 - 0.752
24936-97-8 0.273 - 0.383
7440-44-0 0 - 0.274
1309-64-4 0.112 - 0.190
7440-42-8 0 - 0.164
7723-14-0 0 - 0.164
7704-34-9 0 - 0.109
128-80-3 0.0394 - 0.0578
7631-86-9 0.00422 - 0.00592
112-84-5 0.000683 - 0.00128
121-65-3 0.000286 - 0.000430
Table 7
Model
26 mm 29 mm Basic UDI-
System System
9600TFX 9600TFX 0690103D00
(26 mm) (29 mm) 3SAP000VP
3COM000TC
Product
Edwards
eSheath
Introducer
Set
Inflation
Device
Edwards
Crimper
14.0 Expected Lifetime of the Device
The Edwards Transcatheter Heart Valve has been subjected to rigorous
pre-clinical durability testing per the valve testing requirements and in
clinical studies and post market studies. The valves were successfully
tested to 5 years of simulated wear. In addition, clinical data show
durability with follow-up to 2 years. The actual lifetime performance is
continuing to be studied and varies from patient to patient.
15.0 Patient Information
A patient implant card is provided with each THV. After implantation,
please complete all requested information and provide the implant card
to the patient. The serial number is found on the package. This implant
card allows patients to inform healthcare providers what type of implant
they have when they seek care.
16.0 Recovered THV and Device Disposal
The explanted THV should be placed into a suitable histological fixative
such as 10% formalin or 2% glutaraldehyde and returned to the
company. Refrigeration is not necessary under these circumstances.
Contact Edwards Lifesciences to request an Explant Kit.
Used devices may be handled and disposed of in the same manner as
hospital waste and biohazardous materials. There are no special risks
related to the disposal of these devices.
17.0 Clinical Studies
Refer to the SSCP for clinical benefits.
18.0 References
1. Bapat V, Attia R, Thomas M. Effect of Valve Design on the Stent
Internal Diameter of a Bioprosthetic Valve: A Concept of True Internal
Diameter and Its Implications for the Valve-in-Valve Procedure. JACC:
Cardiovascular Interventions. Vol. 7, No. 2 2014: 115-127.
DI
7
Model
20 mm 23 mm 26 mm
System System System
9610ES14
9610ES16
96402
9600CR
29 mm Basic UDI-
System DI
0690103D00
3S3E000NT
0690103D00
96406
3IND000TG
0690103D00
3CRI000TH