BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 1720067 · Received June 11, 2010

    Report

    Report Number
    2015691-2010-13554
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P010041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX AND E-MAIL), ADDITIONAL INFORMATION WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 41.03 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO DEHISCENCE, MITRAL REGURGITATION, AND PARAVALVULAR LEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2.7 MONTHS. REPORTEDLY, THE PATIENT DIED FROM COMPLICATIONS AFTER THE SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE PATIENT'S POST-OPERATIVE HOSPITALIZATION WAS COMPLICATED BY GI BLEEDING, AND WAS TRANSFERRED TO A COVALENCE HOME IN BRANTFORD. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED TO THE HOSPITAL OR THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2650 08H207

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death