BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1040250 · Received May 7, 2008

    Report

    Report Number
    6000002-2008-07069
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    September 6, 2007
    Report Date
    September 20, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 ZERO DAYS, DUE TO SUTURE TEARING DURING PLACEMENT AND PHYSICIAN COULD NOT REPAIR. ANOTHER MAGNA VALVE WAS IMPLANTED WITH NO REPORTED PT COMPLICATIONS.

    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 R07D0712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention