BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 719172 · Received November 14, 2005

    Report

    Report Number
    2134479-2005-00032
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    October 14, 2005
    Report Date
    October 14, 2005
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED TO DEPLOY THE STENT, HOWEVER ONLY 5MM OF STENT DEPLOYED AND STUCK. THE PHYSICIAN HAD TO USE A LOT OF FORCE AND FINALLY DEPLOYED THE STENT. DURING DEPLOYMENT THE CATHETER SNAPPED AND WAS DAMAGED. THE PHYSICIAN NEEDED TO PULL THE WHOLE SYSTEM OUT, INCLUDING WIRE, HOWEVER THE STENT WAS DEPLOYED PROXIMAL TO THE TARGET LANDING AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT FGE FGE EV3 INC SERB65-06-150-120 1138450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN