BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 16773715 · Received April 19, 2023

    Report

    Report Number
    2135147-2023-01713
    Event Type
    Death
    Date Received
    April 19, 2023
    Date of Event
    July 1, 2019
    Report Date
    April 19, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05414734052030
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, ABOUT FOUR YEARS AFTER A TRIFECTA VALVE WAS IMPLANTED STENOSIS OF VALVE AND PARAPROSTHETIC LEAK WAS NOTED. ABOUT ONE YEAR AFTER THAT A TRANSVALVULAR GRADIENT AND PERI-PROTHESIS LEAKAGE WAS NOTED. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY DUE TO ACUTE RESPIRATORY SYNDROME AND POST SURGICAL PNEUMOPATHY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. A MORE COMPREHENSIVE ASSESSMENT, INCLUDING HISTOPATHOLOGICAL EXAMINATION OF THE VALVE TISSUE COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ABSTRACT ARTICLE, "TRIFECTA BIOPROSTHESES: EVALUATION OF THE SAFETY BASED ON THE STUDY OF DEGENERATIONS ACCORDING TO THE VARC-3 CLASSIFICATION", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE INTRINSIC IMPUTABILITY OF TRIFECTA FOR DYSFUNCTION ACCORDING TO THE VARC-3 CLASSIFICATION IN PATIENTS IMPLANTED AND TO REASSESS THEIR REFERENCING IN OUR CENTER. TRIFECTA VALVE WAS THE DEVICE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED, THE CLASSIFICATION OF FAILURES ACCORDING TO VARC-3 INDICATED THE INTRINSIC IMPUTABILITY OF THE TRIFECTA¿ BIOPROSTHESES REGARDING TO THE NUMBER OF SVD-TYPE DYSFUNCTIONS. ALTHOUGH THIS STUDY HAS LIMITATIONS, IT SHOWS THE UNDERSTATEMENT OF MEDICAL-DEVICES-VIGILANCE CASES BY THE MEDICAL STAFF. [THE PRIMARY AUTHOR OF THIS ARTICLE IS RICHEZ, OPHELIE, AMIENS-PICARDIE UNIVERSITY HOSPITAL, 1 ROND-POINT DU PROFESSEUR CHRISTIAN CABROL, 80054 AMIENS, FRANCE, WITH EMAIL ADDRESS OF : [email protected]]. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2015, A 23MM TRIFECTA VALVE WAS SUCCESSFULLY IMPLANTED IN A 68 YEARS OLD WITH A HISTORY OF GRADE LLL SERIOUS AORTIC DISEASE. ON AN UNKNOWN DATE IN (B)(6) 2019 ULTRASOUND IMAGING SHOWED MODERATE STENOSIS IN THE VALVE, STABLE, LOW PARA PROTHESIS LEAKAGE. LEFT ATRIUM DILATATION 31CM². NO MITRAL VALVOPATHY. NO CONSEQUENCE AT RIGHT SIDE AND NO PULMONARY ARTERIAL HYPERTENSION (HTAP). FEVG OF 65%. ON AN UNKNOWN DATE IN (B)(6) 2020, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED NO DILATATION AT THE LEFT VENTRICULAR, SEPTAL HYPOKINESIA, EJECTION FRACTION (EF) OF 50%, RIGHT VENTRICLE MODERATELY DILATED, MINIMAL MITRAL DISEASE, A FLUCTUANT TRANSVALVULAR GRADIENT (25 TO 40 MMHG VS 24 MMHG IN (B)(6) 2019) VMAX 4M/S VS 3,2M/S IN (B)(6) 2019, WITH A KNOWN PERI-PROTHESIS LEAKAGE. TACHYCARDIA 200BPM IN THE CONTEXT OF COMPLETE ARRHYTHMIA AND ATRIAL FIBRILLATION. ON AN UNKNOWN DATE IN (B)(6) 2020, THE PATIENT PASSED AWAY DUE TO AN ACUTE RESPIRATORY SYNDROME AND A POST SURGICAL PNEUMOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746108 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL TF-A 5101971 05414734052030

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Death