BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1070704 · Received July 2, 2008

    Report

    Report Number
    2183870-2008-00084
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 4, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN OTHER COUNTRY: DURING PULLBACK OF STENT, THE DISTAL PORTION WAS STUCK; THIS MADE IT IMPOSSIBLE TO COMPLETE THE PULLBACK. PHYSICIAN TRIED TO REMOVE THE DEVICE FROM THE GUIDING CATHETER, HOWEVER; HALF OF THE STENT THAT WAS INITIALLY DEPLOYED BROKE OFF AND REMAINED IN EXTERNAL ILIAC LEFT ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRP35-06-060-120 5127022

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other