BEUDAMED
    FDA Adverse Event Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1101755 · Received August 5, 2008

    Report

    Report Number
    6000002-2008-08339
    Date Received
    August 5, 2008
    Date of Event
    September 21, 2007
    Report Date
    October 7, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AORTIC ANEURYSM. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED DUE TO ASCENDING AORTIC ANEURYSM PER OP NOTES FROM SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS NONE LWR EDWARDS LIFESCIENCES 3000 R-07G1360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention