BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 761732 · Received October 20, 2005

    Report

    Report Number
    2134479-2005-00029
    Event Type
    Malfunction
    Date Received
    October 20, 2005
    Date of Event
    September 15, 2005
    Report Date
    September 20, 2005
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    E-MAIL COPY OF X-RAY OF ACTUAL COMPLAINT STENT WAS RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    STENT FRACTURED AT HUNTER'S CANAL. THIS STENT WAS PLACED IN THE DISTAL SFA EXTENDING INTO THE POPLITEAL OVER THE KNEE JOINT. IMPLANT OCCURRED IN 2005 WITH RECENT FOLLOW-UP 4 MOS LATER. X-RAYS WERE TAKEN OF THE IMPLANTED STENT AT THIS TIME TO VISUALIZE AFFECTED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT SELF-EXPANDING NITINOL STENT FGE EV3 INC SERB65-06-150-120 1122427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SMART STENT