Perceval Sutureless Heart Valve (2018-06-21)
- Starting date:
- June 21, 2018
- Posting date:
- June 29, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67146
Affected products
Perceval Sutureless Heart Valve
Reason
LivaNova has recently become aware of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to "stent folding". Moreover, patients with implanted perceval valve may experience valve folding when emergency cardiovascular procedures, such as CPR, are administered post-implant. Valve folding could result in paravalvular or central leakage, high gradient, which may be significant enough to require reoperation. LivaNova is providing clarifications about this adverse event and recommendations to prevent its occurrence. There is no market withdrawal.
Affected products
Perceval Sutureless Heart Valve
Lot or serial number
More than 1000 numbers, contact manufacturer.
Model or catalog number
- PVS21
- PVS23
- PVS25
- PVS27
Companies
- Manufacturer
-
LIVANOVA CANADA CORP.
5005 NORTH FRASER WAY
BURNABY
V5J 5M1
British Columbia
CANADA