BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVE

    MDR report key: 618231 · Received June 27, 2005

    Report

    Report Number
    6000002-2005-00335
    Event Type
    Other
    Date Received
    June 27, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 2, 2005
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE STENT FORESHORTENED DURING DEPLOYMENT SO AN ADDITIONAL STENT WAS DEPLOYED. NO PT INJURY REPORTED. NO DEVICE RETURNED FOR EVALUATION.

    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 NT187802D SE4L0532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention