The warning covers the Medtronic CoreValve Evolut Pro+ 34 mm transcatheter aortic valve replacement (TAVR). It’s dated December 2022, although it was published to a European regulatory site last week.
Medtronic notified customers of a “known phenomenon” that occurs when the valve frame folds inward along a vertical line. This fold, going away from the valve inflow, appears as a seam in the frame or as overlapping frame cells. Infolding is different from valve under-expansion. It may be seen intraprocedurally at deployment or during recapturing of a valve.
The company said the overall incidence of frame unfolding remains low in the Pro+ system, the 34 mm version presents higher rates compared to other sizes. From commercial launch (Oct. 1, 2019) to Aug. 31, 2022, Pro+ 34 mm infolding rate totaled 2.93%. Of this incidence rate, 0.32% resulted in serious adverse events, including two deaths.
Other serious events may include unplanned surgery/intervention. This could include a surgical explant/valve replacement/aortic repair or implantation of a valve within the initial valve. It could also result in aortic regurgitation/insufficiency, paravalvular leak, hypotension, congestive heart failure, and aortic dissection.
Patients treated with Evolut Pro+ should continue to be managed under standard protocols. Medtronic plans to update its Evolut Pro+ instructions for use. The company is not requesting any return of product, according to the notice.
