BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN

    MDR report key: 8590811 · Received May 7, 2019

    Report

    Report Number
    MW5086434
    Event Type
    Death
    Date Received
    May 7, 2019
    Date of Event
    November 2, 2018
    Report Date
    May 3, 2019
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OFF LABEL USE OF WINGSPAN DEVICE, TO TREAT STROKE THAT HAPPENED A DAY BEFORE USE OF DEVICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378377 WINGSPAN INTRACRANIAL NEUROVASCULAR STENT NJE STRYKER NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death