BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1031566 · Received April 18, 2008

    Report

    Report Number
    6000002-2008-06588
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 19, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 AN IMPLANT DURATION OF 4 MOS. THE REASON FOR EXPLANT IS UNK. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY. INFO LEARNED ON 03/31/2008: THE DEVICE WAS EXPLANTED DUE TO PARAVALVULAR LEAK. THE DEVICE WENT TO PATHOLOGY AND IT IS UNK IF IT IS AVAILABLE FOR RETURN. INFO PER SURGEON.

    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 6D0635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention