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