BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 450240 · Received March 21, 2003

    Report

    Report Number
    6000002-2003-00107
    Event Type
    Injury
    Date Received
    March 21, 2003
    Date of Event
    February 14, 2003
    Report Date
    February 20, 2003
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VALVE EXPLANTED AT IMPLANT DUE TO ECHO SHOWING A CENTRAL JET. NO FURTHER INFO WAS PROVIDED.

    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 2K1945

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention