BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 6151081 · Received December 7, 2016

    Report

    Report Number
    3007113487-2016-00048
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    January 20, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A 19 MM TRIFECTA VALVE WAS IMPLANTED. PER REPORT, ON (B)(6) 2016, THE PATIENT DIED DUE TO SEVERE AORTIC REGURGITATION IN THE PRESENCE OF ENDOCARDITIS. AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A 19 MM TRIFECTA VALVE WAS IMPLANTED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015 FOR FEVER AND DYSPNEA AT REST. BLOOD TEST PERFORMED SHOWED STAPHYLOCOCCUS EPIDERMIDIS. THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS AND TREATED WITH ANTIBIOTICS. ON (B)(6) 2016, THE PATIENT DIED DUE TO SEVERE AORTIC REGURGITATION IN THE PRESENCE OF ENDOCARDITIS. AN AUTOPSY WAS NOT PERFORMED. (CLINICAL STUDY PATIENT ID: (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802471 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, INC. TF-19A 3298963

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death