BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1013134 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06190
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, AFTER 4 DAYS AND DIFFICULTY TAKING OFF OF BYPASS DUE TO PULMONARY HYPERTENSION, TEE ON THE FOURTH DAY SHOWED SEVERE MITRAL REGURGE AND DEVICE WAS EXPLANTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention