BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN 100812524, 20900398 3.0X15, 14-300CM EXCHANGE

    MDR report key: 11541382 · Received March 19, 2021

    Report

    Report Number
    MW5100148
    Event Type
    Death
    Date Received
    March 19, 2021
    Date of Event
    February 20, 2021
    Report Date
    March 17, 2021
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VESSEL PERFORATION DURING STENT PLACEMENT CATHETERIZATION WIRE PERFORATION OF VESSEL DURING STENT IMPLANT, STENT IS AN HDE DEVICE. PATIENT TREATED WITH ENDOVASCULAR THERAPY FOR STROKE PATIENT HAD REPEAT STROKE IN ICU REQUIRING REPEAT ENDOVASCULAR STROKE THERAPY. EVENT OCCURRED ON SECOND TREATMENT. MEDICALLY MEDICATED OFF LABEL USE OF HDE DEVICE, DEVICE APPROVED FOR INTRACRANIAL STENOSIS BUT TYPICALLY NOT IN ACUTE SETTING OF ONGOING STROKE EVENT NOT RELATED TO STENT BUT DEPLOYMENT WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429945 WINGSPAN 100812524, 20900398 3.0X15, 14-300CM EXCHANGE INTRACRANIAL NEUROVASCULAR STENT NJE STRYKER NEUROVASCULAR
    429946 SYNCHRO WIRE 47973 WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death