BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1202989 · Received October 16, 2008

    Report

    Report Number
    6000002-2008-08960
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 1, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER IMPLANT DURATION OF ZERO DAYS, BECAUSE "THERE APPEARED TO BE A SPACE NEAR THE LEFT CORONARY OSTIUM." IT WAS NOT FELT SAFE TO CONTINUE, SO THE VALVE WAS REMOVED. NO OTHER DETAILS WERE PROVIDED. INFO LEARNED THROUGH THE OPERATIVE REPORT.

    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 R08H11857

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention