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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 099 06 18 000
Date submitted: 6/27/2018
Manufacturer:LivaNova
Device Type:Perceval Sutureless Heart Valve
Description:Heart Valve
Medical Device Identifier:Item #: REF, Product Description
- ICV1208: PVS21, Perceval Sutureless Aortic Heart Valve size S
- ICV1209: PVS23, Perceval Sutureless Aortic Heart Valve size M
- ICV1210: PVS25, Perceval Sutureless Aortic Heart Valve size L
- ICV1211: PVS27, Perceval Sutureless Aortic Heart Valve size XL
Reason of Field Safety Corrective Action:LivaNova has recently become aware, through its post-market surveillance processes, of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to “stent folding”.
Remedy Action:By means of this voluntary action, LivaNova will be providing clarifications about this potential adverse event related to the Perceval valve and recommendations to prevent its occurrence. We would like to follow this letter with an in-person meeting with you and all the physicians implanting Perceval in your hospital, to discuss key procedural steps to be followed to reduce the occurrence of stent folding, and to provide further information for an early detection of the phenomenon.

You will be contacted by your LivaNova representative to discuss the logistics of scheduling a meeting, and we kindly ask you to facilitate such meeting. indicated in the IFUs, for prevention and early detection of stent folding:

Prevention
1)Decalcification, to avoid uneven surfaces;
2)Correct sizing, using available information in the IFU; and
3)Ballooning, with the recommendation to pour warm sterile saline (at 37°C) while ballooning.

Early detection
1)Visual inspection, checking that the Perceval stent is correctly deployed; and
2)Performing an intraoperative echographic evaluation after Perceval implant to confirm correct positioning and verify valve functionality under beating heart conditions.


There are no required actions for patients already implanted with Perceval outside of normal monitoring and treatment.

If you have additional questions or urgent request for clarification, please contact the reference person reported below, your LivaNova representative.
Athorized Representative/Importer/Distributor:cigalah group
Report Source:NCMDR
Source Ref. Number:8EA665AC3B280
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: LivaNova.pdf