Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX;

On 10/23/2020, the firm sent an "Urgent Medical Device Correction" Notification Letter to customers via UPS 2-day delivery informing them that the Recalling Firm has received complaint of valve leaflet damage occurring following a post-implant balloon dilatation (PID) resulting in moderate or severe aortic insufficiency which were detected acutely or during follow up. The Recalling Firm has identified the potential cause of the damage which is due to over-expansion of the narrowest portion (waist) of the Transcatheter Aortic Valves (TAVs). The Recalling Firm is also stating that depending on the choice of balloon, the physicians must consider two factors that may lead to over-expansion of the waist of the TAV: 1.The pressure the balloon is inflated to when performing PID 2.Balloon size used for PID The Recalling Firm is providing detailed guidance on considering the above two facts and is providing in an Appendix (Appendix A) with the Customer Notification Letter. In addition, the Appendix A is providing updated precautionary instructions related to PID. The Recalling Firm is also informing its customers that for patients who have been, or will be, treated with the affected product, should continue to be managed according to their standard patient management protocols. Physicians are also asked to: - Review the updated instructions provided in Appendix A. - Share this information with other physicians in your facility who use the affected product. - After review of this information, complete the enclosed Physician Confirmation Certificate and email to rs.cfqfca@medtronic.com. Any Questions can be directed to the Recalling Firm's Field Representatives or Lifeline Technical Services at 1-877-526-7890, Monday-Friday, 8am-5pm Central Time.