BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1151440 · Received September 5, 2008

    Report

    Report Number
    6000002-2008-08605
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 27, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO AI (AORTIC INSUFFICIENCY) AND PV LEAK. REPORTEDLY, THE DEVICE WAS IMPLANTED IN 2008. (THE SPECIFIC DATE WAS NOT REPORTED.) THE HLTH CARE PROVIDER INFORMED OUR SALES REP TWO MONTHS LATER, THAT THE REPORTED DEVICE WAS BEING EXPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    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 UNK Required Intervention