BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1040565 · Received May 9, 2008

    Report

    Report Number
    6000002-2008-07150
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF ONE MONTH, DUE TO UNKNOWN REASONS. UNKNOWN IF THE DEVICE WAS EXPLANTED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX R-08A0157

    Patients

    Seq Age Sex Outcome Treatment
    1 Death