BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTEM

    MDR report key: 1032471 · Received April 17, 2008

    Report

    Report Number
    6000002-2008-06539
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD TARGET LESION REVASCULARIZATION. PRODUCT STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTEM BILIARY STENT SYSTEM FGE EDWARDS LIFESCIENCES NT35680IDE SE5G0371

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other