BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVE

    MDR report key: 598019 · Received April 29, 2005

    Report

    Report Number
    6000002-2005-00222
    Event Type
    Other
    Date Received
    April 29, 2005
    Date of Event
    April 1, 2005
    Report Date
    April 1, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STENT WAS DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY. DURING DEPLOYMENT THE STENT FORESHORTENED SO ANOTHER STENT WAS NEEDED TO BE DEPLOYED TO COVER THE LESION. NO PT INJURY. NOTE, THIS DEVICE WAS BEING USED OFF LABEL, AS IT IS INDICATED 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 DELIVE BILIARY STENT FGE EDWARDS LIFESCIENCES NT357402D RSE4M0044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention