COREVALVE EVOLUT R & COREVALVE EVOLUT PRO (2020-10-23)
- Starting date:
- October 23, 2020
- Posting date:
- November 13, 2020
- 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-74295
Last updated:
2020-11-13
Affected Products
A. COREVALVE EVOLUT R
B. COREVALVE EVOLUT R
C. COREVALVE EVOLUT PRO TRANSCATHETER AORTIC VALVE
D. EVOLUT PRO+
Reason
This notification is to provide customers with important information regarding updates to the Instructions for Use (IFU) manuals specifically, regarding the risk of TAV leaflet damage when performing a post-implant balloon dilatation (PID).
Medtronic has identified that over-expansion of the narrowest portion (waist) of the TAV can potentially cause damage to the bioprosthetic leaflets. Depending on the choice of balloon, the physicians must consider two factors that may lead to over-expansion of the waist of the TAV:
- The pressure the balloon is inflated to when performing PID
- Balloon size used for PID
Medtronic is not retrieving product from the field per this medical device correction, as this notification provides updated precautionary instructions related to PID.
Affected products
A. COREVALVE EVOLUT R
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
EVOLUTR-34-US
Companies
- Manufacturer
-
MEDTRONIC COREVALVE LLC
1851 East Deere Avenue
Santa Ana
92705
California
UNITED STATES
B. COREVALVE EVOLUT R
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
EVOLUTR-23
EVOLUTR-26
EVOLUTR-29
EVOLUTR-34
Companies
- Manufacturer
-
MEDTRONIC COREVALVE LLC
1851 East Deere Avenue
Santa Ana
92705
California
UNITED STATES
C. COREVALVE EVOLUT PRO TRANSCATHETER AORTIC VALVE
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
EVOLUTPRO-23
EVOLUTPRO-26
EVOLUTPRO-29
Companies
- Manufacturer
-
MEDTRONIC COREVALVE LLC
1851 East Deere Avenue
Santa Ana
92705
California
UNITED STATES
D. EVOLUT PRO+
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
EVPROPLUS-34US
Companies
- Manufacturer
-
MEDTRONIC COREVALVE LLC
1851 East Deere Avenue
Santa Ana
92705
California
UNITED STATES