BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1317562 · Received February 9, 2009

    Report

    Report Number
    6000002-2009-09796
    Event Type
    Death
    Date Received
    February 9, 2009
    Date of Event
    December 8, 2008
    Report Date
    January 19, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED APPROXIMATELY AFTER IMPLANT DURATION OF LESS THAN A MONTH, DUE TO CARDIAC ARREST DUE TO OR AS A CONSEQUENCE OF MULTIORGAN SYSTEM FAILURE DUE TO OR AS A CONSEQUENCE OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (PER DEATH CERTIFICATE). IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000 R-08K2231

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death