BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 7227701 · Received January 30, 2018

    Report

    Report Number
    2025587-2018-00236
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 30, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169954441
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. WITHOUT RETURN OF THE DEVICE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS INTENTIONALLY DEPLOYED AT 0MM AND DISLODGED UPWARD DURING THE FINAL RELEASE. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE STABLE AFTER SUCCESSFUL VALVE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71565 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26-US 00643169954441

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention