BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 16817349 · Received April 26, 2023

    Report

    Report Number
    2135147-2023-01836
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    April 1, 2021
    Report Date
    April 26, 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 A PATIENT HAD THE VALVE EXPLANTED 8 YEARS AFTER IMPLANT DUE TO VALVE DEGENERACY, WITH THE PATIENT HAVING MULTIPLE POST-SURGICAL COMPLICATIONS. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY ABOUT 3 MONTHS LATER DUE TO A CARDIOGENIC AND SEPTIC SHOCK DUE TO MASSIVE INHALATION AT THE SECOND COMA, REFRACTORY TO ANY THERAPY, WITH ACUTE RESPIRATORY DISTRESS SYNDROME. 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, HOWEVER IT WAS INDICATED THAT THE VALVE WAS "TOTALLY DESTROYED" AND CALCIFIED UPON EXPLANT, WHICH WOULD THE CAUSE THE VALVE TO MALFUNCTION. 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) 2013, A 23MM TRIFECTA VALVE WAS IMPLANTED FOR NATIVE VALVE ENDOCARDITIS OF A 37 YEAR OLD PATIENT. THE TRIFECTA WAS IMPLANTED AT THE AORTIC AND THE PERIMOUNT AT THE MITRAL VALVE. IN APRIL OF 2021, IT WAS REPORTED DYSPNEA PROGRESSIVELY INCREASED DURING THE 3 TO 4 MONTHS AND THE AORTIC VALVE SHOWED A STENOSANT IMAGE AND CENTRAL AORTIC LEAK GRADE 1. IN (B)(6) 2021, A BIOPROTHESIS DEGENERACY WAS REPORTED. IN (B)(6) 2021, AN AORTIC PROTHESIS DEGENERACY WAS REPORTED AND A REOPERATION WAS NECESSARY. ON (B)(6) 2021, ULTRASOUND SHOWED THE LEFT VENTRICLE EJECTION FRACTION OF 55%, SLIGHTLY DILATED LEFT VENTRICLE, INFERIROR VENA CAVA VEIN DILATED BUT COMPLIANT. THERE WAS ALSO GRADE 1 TRICUSPID LEAK, STENOSIS NOTED ON AORTIC PROSTHESIS AND LEAKAGE WITH A GRADIENT OF 86 MMHG. IN AUGUST OF 2021, THE TRIFECTA VALVE WAS REPLACED WITH A 21 MM SJM REGENT HEART VALVE W/FLEX CUFF. THE REMOVED TRIFECTA VALVE WAS TOTALLY DESTROYED AND CALCIFIED, AND THE PATIENT SUFFERED WITH MULTIPLE POST-SURGICAL COMPLICATIONS. IN (B)(6) 2021, THE PATIENT PASSED DUE TO A CARDIOGENIC AND SEPTIC SHOCK DUE TO MASSIVE INHALATION AT THE SECOND COMA, REFRACTORY TO ANY THERAPY, WITH SERIOUS MIXT SDRA (ACUTE RESPIRATORY DISTRESS SYNDROME). UNDO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477650 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL TF-A 3538399 05414734052030

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown Required Intervention