BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3 EVERFLEX STENT

    MDR report key: 12324849 · Received August 13, 2021

    Report

    Report Number
    MW5103247
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 11, 2021
    Manufacturer
    EV3 INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CRACK WHERE STENT IS MOUNTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214683 EV3 EVERFLEX STENT STENT, SUPERFICIAL FEMORAL ARTERY NIP EV3 INC. B205543

    Patients

    Seq Age Sex Outcome Treatment
    1