BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS

    MDR report key: 1101084 · Received August 4, 2008

    Report

    Report Number
    6000002-2007-53740
    Event Type
    Injury
    Date Received
    August 4, 2008
    Date of Event
    March 3, 1998
    Report Date
    May 24, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AFTER APPROX A 9 YEAR, 2 MONTH IMPLANT DURATION DUE TO AORTIC DEGENERATION AND AORTIC INSUFFICIENCY. LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2625 7H0851

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention