Health product recall

Evolut Pro+ Transcatheter Aortic Valve

Last updated

Summary

Product
Evolut Pro+ Transcatheter Aortic Valve
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Evolut Pro+ Transcatheter Aortic Valve More than 10 numbers, contact manufacturer. EVPROPLUS-34

Issue

Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on radiographic imaging. Infolding is different and distinct from valve under expansion and may be seen intraprocedurally at deployment or during recapturing of a valve.
Although the overall incidence of frame infolding is low in Pro+ TAVs, the Pro+ 34mm TAV has been associated with higher rates of infolding than other Pro+ sizes. From commercial launch on 01-October-2019 to 31-August-2022, the Pro+ 34mm TAV infolding rate was 2.93% of this incidence rate, 0.32% resulted in serious adverse events, including two (2) deaths. Other serious adverse events may include unplanned surgery/intervention, such as surgical explant / valve replacement /aortic repair or implantation of a transcatheter valve within the initial valve (tav in tav), aorticpage 2 of 4 regurgitation/insufficiency, paravalvular leak, hypotension, congestive heart failure, and aortic dissection.
In accordance with Medtronic's commitment to patient safety, we will be updating the instructions for use (IFU) with respect to:
• detection of infold
• removal of an infolded valve and replacement with a new system
• pre-dilatation guidance

Recall start date: December 5, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Medtronic Corevalve Llc

1851 East Deere Avenue, Santa Ana, California, United States, 92705

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-72354