BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1050205 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07278
    Event Type
    Death
    Date Received
    May 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED DUE TO UNK REASONS. IT IS UNK IF THE PT'S DEATH WAS DEVICE RELATED. IMPLANT DURATION WAS APPROX 0.27 MO. 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 PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2700 R-07L2315

    Patients

    Seq Age Sex Outcome Treatment
    1 Death