BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1251663 · Received December 1, 2008

    Report

    Report Number
    6000002-2008-09369
    Event Type
    Death
    Date Received
    December 1, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ZERO DAYS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PATIENT HAD TWO OTHER DEVICES IMPLANTED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANTED PATIENT REGISTRY. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL # 6900P, WAS IMPLANTED. REEFER TO MFR REPORT# 6000002-2008-09368. IT WAS ADDITIONALLY REPORTED THAT A THIRD DEVICE, MODEL # 4900, WAS IMPLANTED. REFER TO MFR REPORT# 6000002-2008-09370.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death