BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT OMNI LINK .035 BILIARY STENT SYSTEM

    MDR report key: 813033 · Received February 5, 2007

    Report

    Report Number
    MW1041860
    Event Type
    Injury
    Date Received
    February 5, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 5, 2007
    Manufacturer
    GUIDANT CORP
    Product Code
    FGE
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN POSITIONING STENT FROM RIGHT FEMORAL ARTERY AROUND BIFURCATION, STENT DISLODGED FROM DELIVERY BALLOON IN THE RIGHT ILIAC ARTERY. FBO STENT WAS SNARED AND RETRIEVED VIA RIGHT FEMORAL ARTERY SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT OMNI LINK .035 BILIARY STENT SYSTEM OMNI LINK STENT FGE GUIDANT CORP 1008182-38 6112051

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability