BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1013162 · Received March 13, 2008

    Report

    Report Number
    6000002-2008-06211
    Event Type
    Death
    Date Received
    March 13, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 13, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS NOT EXPLANTED AFTER PT EXPIRED. IN SEPT OF 07 THE PT HAD A MITRAL AND AORTIC VALVE IMPLANTED DUE TO ENDOCARDITIS. FOUR MONTH LATER PT EXPIRED. CUSTOMER CHECKED VALVES AND PVE WAS FOUND. VALVE LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900P 07C051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death