BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1100509 · Received August 6, 2008

    Report

    Report Number
    6000002-2008-08356
    Event Type
    Death
    Date Received
    August 6, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S018
    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

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO HEART FAILURE. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #2700, WAS EXPLANTED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #2700, WAS EXPLANTED.

    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-08B0355

    Patients

    Seq Age Sex Outcome Treatment
    1 Death