BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS LIFESTENT NT SELF EXPLANDING BILIARY STENT & DELIVER

    MDR report key: 598142 · Received April 29, 2005

    Report

    Report Number
    6000002-2005-00220
    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

    THIS STENT WAS USED IN THE SUPERFICIAL FEMORAL ARTERY. DURING DEPLOYMENT, THE STENT FORESHORTENED AND DEPLOYED TO APPROXIMATELY 75MM INSTEAD OF 90MM SO ANOTHER STENT WAS DEPLOYED AS THE VESSEL DIDN'T LOOK OPTIMAL TO THE CARDIOLOGIST. NOTE THIS DEVICE IS BEING USED OFF LABEL AS IT'S INDICATED FOR USE IN THE BILIARY TREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESTENT NT SELF EXPLANDING BILIARY STENT & DELIVER BILIARY STENT SYSTEM FGE EDWARDS LIFESCIENCES NT357902D SE5B0251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention