BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS.

    MDR report key: 372248 · Received January 18, 2002

    Report

    Report Number
    6000002-2002-00037
    Event Type
    Injury
    Date Received
    January 18, 2002
    Date of Event
    December 17, 2001
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS AN EXPLANT AT IMPLANT DUE TO ECHO/TEE SHOWING A 'MALFUNCTIONING VALVE' AND MASSIVE MITRAL REGURGITATION WITH A CENTRAL JET. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS. REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900 1E0705

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention