BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3, INC

    MDR report key: 2319505 · Received October 27, 2011

    Report

    Report Number
    MW5022891
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    October 24, 2011
    Report Date
    October 27, 2011
    Manufacturer
    EV3, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER OPERATING ROOM NURSE'S DESCRIPTION: "STENT FELL OFF OF BALLOON BEFORE IT COULD BE PLACED WHERE IT WAS INTENDED. SURGEON WAS ABLE TO PLACE STENT ON ANOTHER LESION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3, INC BALLOON EXPANDABLE STENT FGE EV3, INC. 9479112

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR