BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1060308 · Received June 12, 2008

    Report

    Report Number
    6000002-2008-07541
    Event Type
    Death
    Date Received
    June 12, 2008
    Date of Event
    March 11, 2008
    Report Date
    May 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2008, SAME DAY OF THE SURGERY DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT 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 7G1402

    Patients

    Seq Age Sex Outcome Treatment
    1 Death