BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1780102 · Received August 2, 2010

    Report

    Report Number
    2015691-2010-13830
    Event Type
    Death
    Date Received
    August 2, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 7, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WERE RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1.80 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A RESPONSE AND A COPY OF THE OPERATIVE REPORT WERE RECEIVED. IT WAS NOTED THAT PATIENT HAD AN INFECTIOUS DISEASE - CELLULITIS OF LEG. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN. PER THE OPERATIVE REPORT OF (B)(6) 2010, THAT THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10A0171

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death