BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 842143 · Received April 18, 2007

    Report

    Report Number
    2183870-2007-00028
    Event Type
    Other
    Date Received
    April 18, 2007
    Date of Event
    March 23, 2007
    Report Date
    March 23, 2007
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN THE SFA. JUST AFTER STENT DEPLOYMENT, IT APPEARS THAT THERE WAS A STRUT FRACTURE IN THE MID PORTION OF THE STENT. POST DILATATION THEN WAS PERFORMED USING A 6X16MM BALLOON. ALL DEVICES WERE REMOVED, AND FINAL ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED TIMI 3 FLOW THROUGH OUT THE SFA. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT STENT FGE EV3 INC. PRB35-07-060-120 2399542

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR ADMIRAL BALLOON| SAILER PTA BALLOON| STERLING PTA BALLOON