The CoreValve Evolut R and CoreValve Evolut Pro devices were listed in the notice as devices for which there were updates to the instructions for use manuals, specifically regarding the risk of transcatheter aortic valve (TAV) leaflet damage when performing a post-implant balloon dilation (PID).
As of Oct. 8, 2020, Medtronic had received reports of Evolut valve leaflet damage following PID at a rate of 0.02%, with complaints reporting damage to the bioprosthetic leaflets resulted in moderate or severe aortic insufficiency detected acutely or during follow-up.
“As always, Medtronic is committed to patient safety and is communicating this information to the appropriate regulatory agencies,” Medtronic spokesperson Joey Lomicky told MassDevice.
Reported events required reintervention (77%), conversion to surgery (19%), reintervention followed by surgery (2%) or were treated conservatively (2%). However, no other serious adverse event outcomes associated with these events were reported.
Through an investigation, Medtronic identified that over-expansion of the narrowest portion (waist) of the TAV can potentially damage the leaflets. In relation to the issue, the company said physicians must consider the pressure the balloon is inflated to when performing PID and the size of the balloon used for PID.
Medtronic is not pulling the product from the field as the notice offers updated precautionary instructions related to PID, and the Evolut products maintain compliance to all applicable medical device safety standards. Patients who have been or will be treated with an Evolut TAV should continue to be managed according to standard patient management protocols, the company said.