BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFT

    MDR report key: 1033264 · Received April 21, 2008

    Report

    Report Number
    6000002-2008-06595
    Event Type
    Death
    Date Received
    April 21, 2008
    Report Date
    March 20, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY PT EXPIRED, DUE TO UNK REASONS. UNK IF PT DEATH IS DEVICE RELATED. DATE OF PT'S DATE AND IMPLANT DURATION IS UNK. PT ALSO HAD A T08050C50 IMPLANTED IN 2005. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFT SYNTHETIC PTFE VASCULAR GRAFT DSY EDWARDS LIFESCIENCES T06080C80 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death