BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1190295 · Received October 6, 2008

    Report

    Report Number
    2183870-2008-00134
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 4, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STENT WAS DEPLOYED IN THE SFA. STENT WAS HALF DEPLOYED IN THE BODY WHEN THE DELIVERY SYSTEM BROKE. HALF OF THE STENT STAYED IN THE BODY AND HALF CAME OUT WITH THE SYSTEM. THE STENT FRAGMENT THAT WAS LEFT IN THE BODY WAS COVERING HALF OF THE LESION. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-07-150-120 6059703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention