BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIFECTA GT VALVE

    MDR report key: 12337009 · Received August 18, 2021

    Report

    Report Number
    3007113487-2021-00018
    Event Type
    Death
    Date Received
    August 18, 2021
    Date of Event
    August 15, 2020
    Report Date
    September 13, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWR
    UDI-DI
    05415067018212
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF REGURGITATION, POSSIBLE LEAFLET TEARS, AND PATIENT DEATH WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    UPDATED EVENT DESCRIPTION : IT WAS REPORTED THAT ON (B)(6) 2017, A TRIFECTA GT WAS IMPLANTED WITH THE NON-EVERTING MATTRESS SUTURE TECHNIQUE USING SPAGHETTI-TYPE PLEDGETS IN THE PATIENT'S AORTIC POSITION DUE TO AORTIC REGURGITATION CAUSED BY THE BICUSPID VALVE. THERE WAS SOME CARDIAC MURMUR CONFIRMED DURING THE PERIODIC OUTPATIENT FOLLOW-UP IN (B)(6) 2020. EXAMINATION WAS PERFORMED BUT THERE WAS NO PROBLEM, WITH THE PEAK VELOCITY(VMAX) OF 2.31M/SEC, MEAN PRESSURE GRADIENT (MPG) OF 11.4MMHG AND PEAK PRESSURE GRADIENT(PPG) OF 21.4MMHG AT THAT TIME. ON (B)(6) 2020, THE PATIENT WAS TRANSPORTED BY EMERGENCY WITH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) DUE TO CARDIAC ARREST AT NIGHT. THE PATIENT ONCE RECOVERED, BUT REOPERATION WAS ABANDONED DUE TO WHOLE CEREBRAL ISCHEMIA. AORTIC REGURGITATION WAS CONFIRMED MAINLY FROM THE RIGHT CORONARY CUSP (RCC) AND THE LEFT CORONARY CUSP (LCC) OF THE TRIFECTA GT VALVE BY ECHOCARDIOGRAPHY. THE PATIENT PASSED AWAY ON (B)(6) 2020. THE ISSUE WAS THOUGHT TO BE DUE TO TEARS ON THE TRIFECTA GT VALVE, DUE TO STRUCTURAL VALVE DETERIORATION OF THE VALVE. PATIENT COMORBIDITIES INCLUDED GALLSTONES AND MASTOPATHY. NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236867 TRIFECTA GT VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, INC. TFGT-21A 5595684 05415067018212

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death