BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

    MDR report key: 1810318 · Received August 20, 2010

    Report

    Report Number
    2015691-2010-13930
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    May 10, 2010
    Report Date
    July 22, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K781999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7.83 MONTHS. ON 07/30/2010(THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PULMONARY STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT VALVED CONDUIT DYE EDWARDS LIFESCIENCES 4300 R-08C0495

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention