BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1798303 · Received August 12, 2010

    Report

    Report Number
    2015691-2010-13880
    Event Type
    Death
    Date Received
    August 12, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 13, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED, (B)(4). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS NOT EXPLANTED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY NOTED TO REFERENCE THE OTHER MEDWATCH REPORT FILED UNDER PATIENT IDENTIFIER (B)(4); HOWEVER, THAT EVENT IS BEING REPORTED ON A QUARTERLY ALTERNATIVE SUMMARY REPORT (ASR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 80.87 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA TELEPHONE, IT WAS LEARNED THAT THE IMMEDIATE CAUSE OF DEATH WAS AORTIC STENOSIS, SECONDARY TO CONGESTIVE HEART FAILURE. IT WAS ALSO NOTED THAT THE NATURE OF DEATH WAS NATURAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 17.3 MMOL/L AND 8.3 MMOL/L WITHIN 10 MINUTES ON THE AVIVA NANO SYSTEM. CUSTOMER TESTED 7.6 MMOL/L AND 7.8 MMOL/L WITHIN 2 MINUTES OF TESTING 8.3 MMOL/L. SHE TOOK HUMALOG AND 1.5 HOURS LATER REPORTED LOW BLOOD GLUCOSE SYMPTOMS. CUSTOMER SELF TREATED WITH CEREAL, AND TESTED 3.6 MMOL/L. 20 MINUTES LATER CUSTOMER TESTED 6 MMOL/L AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 3H1353

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death