BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 13588202 · Received February 23, 2022

    Report

    Report Number
    3005334138-2022-00119
    Event Type
    Injury
    Date Received
    February 23, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, COMPLICATIONS FROM HAVING A PERICARDIAL TISSUE VALVE IMPLANTED INCLUDED STROKE, CARDIAC ARREST, RENAL FAILURE, BLEEDING, EXTRACORPOREAL MEMBRANE OXYGENATION USE, REINTUBATION, ENDOCARDITIS, PACEMAKER IMPLANT, MEDIASTINAL REOPERATION, THROMBOEMBOLIC EVENT, VALVE FAILURE DUE TO PULMONARY STENOSIS, PULMONARY INSUFFICIENCY, ATRIAL FIBRILLATION, AND PARAVALVULAR LEAK. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE FOR A TRIFECTA VALVE, ARTEN(B)(4) REVISION A "PRECAUTIONS: THE SAFETY AND EFFECTIVENESS OF THE TRIFECTA VALVE HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING SPECIFIC POPULATIONS. PATIENTS REQUIRING PULMONIC OR TRICUSPID VALVE REPLACEMENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2022-00127, 3005334138-2022-00126. THE ARTICLE, "BIOPROSTHETIC PULMONARY VALVE DYSFUNCTION IN CONGENITAL HEART DISEASE", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE SINGLE STUDY EXPERIENCE THAT AIMS TO IDENTIFY THE INCIDENCE AND TIMING OF DYSFUNCTION AND FAILURE OF STENTED BIOPROSTHETIC VALVES IN THE PULMONARY POSITION IN CONGENITAL HEART DISEASE PATIENTS. PERIMOUNT MAGNA, MAGNAEASE (EDWARDS LIFE SCIENCES) , TRIFECTA, BIOCOR, EPIC AORTIC, SUPRA AORTIC AND MITRAL VALVES (ABBOTT) AND MOSAIC, MOSAIC ULTRA, MOSAIC ULTRA CINCH VALVES (MEDTRONIC) WERE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED PORCINE STENTED AND BOVINE PERICARDIAL STENTED VALVES CAN BE IMPLANTED IN THE PULMONARY POSITION IN ALL AGE GROUPS SAFELY. HOWEVER, DESPITE SIMILAR RATES OF VALVE FAILURE, BOVINE PERICARDIAL STENTED VALVES HAVE A HIGHER INCIDENCE OF VALVE DYSFUNCTION AT MID-TERM FOLLOW-UP. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS ARTICLE IS PARTH M. PATEL MD, DIVISION OF CARDIOTHORACIC SURGERY, EMORY UNIVERSITY SCHOOL OF MEDICINE, 1365 CLIFTON ROAD, ATLANTA, GA 30322, WITH EMAIL ADDRESS: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128818 TRIFECTA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention