BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1572312 · Received January 8, 2010

    Report

    Report Number
    2015691-2010-12454
    Event Type
    Death
    Date Received
    January 8, 2010
    Date of Event
    December 4, 2009
    Report Date
    December 8, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    PULMONARY EDEMA VERSUS AMIODARONE INDUCED TOXICITY, REDO ASCENDING AORTIC ARCH REPLACEMENT AND AORTIC VALVE AND MITRAL VALVE REPLACEMENT, BILATERAL PULMONARY INFILTRATES, SEPSIS, TACHYBRADY SYNDROME, ATRIAL FIBRILLATION.DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT'S REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION, THE OPERATIVE REPORT OF 2009, AND THE DISCHARGE SUMMARY WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. THE PATIENT ALSO HAD OTHER RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF APPROXIMATELY 1 MONTH. INFORMATION WAS LEARNED THROUGH A RELATED EVENT FOR THIS PATIENT. THE PATIENT ALSO HAD ANOTHER VALVE IMPLANTED. IN 2009 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), THE PATIENT'S DISCHARGE SUMMARY WAS RECEIVED.DISCHARGE DIAGNOSES: PULMONARY EDEMA VERSUS AMIODARONE INDUCED TOXICITY, REDO ASCENDING AORTIC ARCH REPLACEMENT AND AORTIC VALVE AND MITRAL VALVE REPLACEMENT, BILATERAL PULMONARY INFILTRATES, SEPSIS, TACHYBRADY SYNDROME, ATRIAL FIBRILLATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE FAILED TO CONNECT TO A PT IN CARDIAC ARREST AND PROVIDE DEFIBRILLATION THERAPY. THERE WAS A DELAY IN PT TREATMENT AS THE DEVICE ALARMED THE "CONNECT ELECTRODES" MESSAGE WHEN USERS ATTEMPTED TO ANALYZE PT'S RHYTHM AND PROVIDE THERAPY USING THIRD PARTY ELECTRODES, KENDALL, THROUGH THE THERAPY CABLE. THE PT WAS NOT RESUSCITATED. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09H1906

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death