BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1913236 · Received December 2, 2010

    Report

    Report Number
    2015691-2010-14471
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. 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

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT EXPIRED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF APROXIMATELY 1 MONTH. UNFORTUNATELY, NO FURTHER INFORMATION WAS PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10E1245

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death