BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX LONG SELF EXPANDING NITINOL STENT

    MDR report key: 1232712 · Received November 14, 2008

    Report

    Report Number
    2183870-2008-00177
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 2, 2007
    Report Date
    October 29, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN ANOTHER COUNTRY: AT 6-MONTH FOLLOW-UP, IT WAS JUDGED BY THE SITE THAT THERE WERE NO STENT FRACTURES SEEN AT X-RAY IN THE SFA. AN INDEPENDENT EVALUATION, WAS PERFORMED AND A TYPE I FRACTURE OBSERVED. THE IMAGES REVEAL THAT THE STENT WAS IMPLANTED IN AN IRREGULAR LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX LONG SELF EXPANDING NITINOL STENT FGE EV3 INC. PRP35-06-150-120 1672167

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other