BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE GPS BILIARY STENT SYSTEM

    MDR report key: 875508 · Received July 3, 2007

    Report

    Report Number
    2183870-2007-00047
    Event Type
    Other
    Date Received
    July 3, 2007
    Date of Event
    June 13, 2007
    Report Date
    June 13, 2007
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED IN THE RIGHT SFA: PT IN LAB FOR LEFT POPLITEAL DISEASE. PHYSICIAN ALSO LOOKED AT THE RIGHT SIDE SFA PRIOR TO ENDING PROCEDURE. ANGIO SHOWED CALCIFIED LESION AND POSSIBLE STRUT FRACTURE IN THE PROTEGE STENT. MODERATE STENOSIS IN-STENT LESION DISTAL TO STENT. NO PROCEDURE DONE AT THIS TIME. THE PROTEGE WAS IMPLANTED IN 2005. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE GPS BILIARY STENT SYSTEM FGE EV3 INC. SERB65-08-150-120 589735

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR