BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1062863 · Received June 17, 2008

    Report

    Report Number
    2183870-2008-00076
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 19, 2008
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, PT RETURNED TO CCL WITH LEG PAIN. UPON DIAGNOSTIC EXAMINATION PHYSICIAN NOTICED THAT THE POPLITEAL STENT IMPLANTED 6 MONTHS PREVIOUSLY WAS OCCLUDED. UPON FURTHER EXAMINATION, PHYSICIAN NOTICED THAT THIS STENT WAS ACTUALLY FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-06-150-120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 6FR SHEATH