BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTEM

    MDR report key: 1020944 · Received March 27, 2008

    Report

    Report Number
    6000002-2008-06377
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT ARTERIOGRAM REVEALED IN-STENT STENOSIS WHICH WAS TREATED SUCCESSFULLY BY ANGIOPLASTY WITH CUTTING EDGE BALLOON.

    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 NT18660IDE SE5A0225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other