Evolut Pro+ Transcatheter Aortic Valve

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