BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1654965 · Received April 9, 2010

    Report

    Report Number
    2015691-2010-13092
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) = RENAL FAILURE. DEVICE REMAINS IMPLANTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT FOR (B) (6) 2010 WAS RECEIVED. THROUGH FURTHER FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE CAUSE OF DEATH WAS RENAL FAILURE. IT WAS ALSO LEARNED THAT AN AUTOPSY WAS NOT PERFORMED. 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

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.7 MONTHS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA A TELEPHONE CALL), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS RENAL FAILURE. NO FURTHER DETAILS REGARDING THE EVENT WERE PROVIDED. PER THE OPERATIVE REPORT OF (B) (6) 2010, "THE PATIENT APPEARED TO HAVE TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION IN NORMAL SINUS RHYTHM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09K2448

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death