BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CORE VALVE EVOLUT R TRANSCARHETER AORTIC VALVE BIOPROSTHESIS

    MDR report key: 6916178 · Received October 5, 2017

    Report

    Report Number
    MW5072624
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 20, 2017
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING A TAVR PROCEDURE THE VALVE DELIVERY SYSTEM MALFUNCTIONED AND THE VALVE ALONG WITH THE DELIVERY SECTION OF THE DEVICE SEPARATED FROM THE SHAFT. A CUT DOWN WAS PERFORMED ON THE LEFT FEMORAL ARTERY. THE VALVE DELIVERY SYSTEM WAS REMOVED. DUE TO SIGNIFICANT DAMAGE TO THE LEFT FEMORAL ARTERY THE PROCEDURE WAS ABORTED. THE LEFT FEMORAL ARTERY WAS REPAIRED. THE VALVE DELIVERY SYSTEM SEPARATED FROM THE SHAFT. THERE WAS SIGNIFICANT DAMAGE TO THE LEFT FEMORAL ARTERY WHICH WAS REPAIRED. THE TAVR PROCEDURE HAD TO BE ABORTED. DATE THE IMPLANT WAS PUT IN: PROCEDURE ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698678 MEDTRONIC CORE VALVE EVOLUT R TRANSCARHETER AORTIC VALVE BIOPROSTHESIS MEDTRONIC CORE VALVE EVOLUT R TRANSCARHETER AORTIC VALVE BIOPROSTHESIS NPT MEDTRONIC COREVALVE LLC
    698679 MEDTRONIC ENVEO R DELIVERY CATHETER SYSTEM MEDTRONIC ENVEO R DELIVERY CATHETER SYSTEM NPT MEDTRONIC COREVALVE LLC 0008653239

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other