BEUDAMED
    FDA Recall Terminated

    Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.

    Recall: Z-0561-2021 · Initiated October 23, 2020

    Recall

    Recall Number
    Z-0561-2021
    Event Number
    86681
    Firm
    Medtronic Heart Valves Division
    FEI Number
    2025587
    Product Code
    NPT
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 23, 2020
    Terminated
    November 22, 2022
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720

    Description

    Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.

    Reason

    Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

    Action

    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 [email protected]. 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.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution and the countries of Panama, Denmark, Austria, Germany, Finland, Sweden, Colombia, India, Mexico, Brazil, Spain, United Kingdom, Australia, Ireland, Italy, Argentina, Japan, Poland, Russian Federation, Hungary, Kazakhstan, Luxembourg, Portugal, Norway, Egypt, Saudi Arabia.

    Quantity

    19,961 units