BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

    MDR report key: 1841824 · Received September 23, 2010

    Report

    Report Number
    2015691-2010-14096
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K781999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    REPORTEDLY, A VALVE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY, RETURN OF DEVICE IS NOT EXPECTED AS IT IS A COMPLICATED REDO OPERATION, AND THE VALVE WILL BE SIGNIFICANTLY DAMAGED AT EXPLANT. ORIGINAL IMPLANT DATE WAS (B)(6)2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT VALVE CONDUIT DYE EDWARDS LIFESCIENCES 4300 8J1083-2

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention