BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIV

    MDR report key: 702014 · Received August 17, 2005

    Report

    Report Number
    6000002-2005-00461
    Event Type
    Other
    Date Received
    August 17, 2005
    Date of Event
    July 21, 2005
    Report Date
    July 21, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THIS STENT WAS BEING USED IN THE HIGHLY CALCIFIED LEFT PROXIMAL SFA. ON DEPLOYMENT SAW STENT HAD COMPRESSED. PT WAS CONVERTED TO SURGERY FOR AN ENDARTERECTOMY DUE TO REPORTED LACK OF BLOOD FLOW. SURGEON DOESN'T KNOW IF DUE TO STENT. DEVICE WAS REPORTEDLY BEING USED IN THE SFA, HOWEVER, THE DIRECTIONS FOR USE STATE THAT IT IS INTENDED FOR USE IN THE BILIARY TREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIV BILIARY STENT FGE EDWARDS LIFESCIENCES NT357902D SSE5C0494

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention