BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL VASCULAR ENGINEERING

    MDR report key: 182101 · Received August 4, 1998

    Report

    Report Number
    MW1014376
    Event Type
    Malfunction
    Date Received
    August 4, 1998
    Date of Event
    July 31, 1998
    Report Date
    August 4, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT COULD NOT BE DEPLOYED. UNABLE TO REMOVE STENT VIA GUIDER. STENT, BALLOON, AND GUIDER REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL VASCULAR ENGINEERING STENT AND GUIDER FGE ARTERIAL VASCULAR ENGINEERING, INC. AVE DGFW3018 8E26E14

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR