BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT¿ FX

    MDR report key: 17563493 · Received August 17, 2023

    Report

    Report Number
    17563493
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 15, 2023
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    UDI-DI
    00763000370701
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE STRUT BENT DURING TRANSCATHETER AORTIC VALVE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736371 EVOLUT¿ FX AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE LLC EVOLUTFX-29 00763000370701

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Female