BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1069109 · Received July 3, 2008

    Report

    Report Number
    6000002-2008-07718
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, VALVE WAS EXPLANTED AT IMPLANT, DUE TO A 'SIGNIFICANT' CENTRAL JET. NO OTHER DETAILS WERE PROVIDED. INCIDENT DATE IS CURRENTLY UNK, SO THE AWARE DATE IS BEING USED AS THE INCIDENT DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention