BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1001917 · Received February 21, 2008

    Report

    Report Number
    6000002-2008-06079
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    August 14, 2007
    Report Date
    January 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AFTER IMPLANT DUE TO REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention