BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA¿ GT VALVE

    MDR report key: 17789640 · Received September 21, 2023

    Report

    Report Number
    2135147-2023-04113
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    July 31, 2018
    Report Date
    September 21, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05415067018212
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF MODERATE AORTIC REGURGITATION AND VALVULAR ATRIAL FIBRILLATION (AF) WAS REPORTED. IT WAS ALSO REPORTED THAT THE TRIFECTA AORTIC VALVE HAD MILD DEGENERATION CHANGES WITH NO STENOSIS. A MORE COMPREHENSIVE ASSESSMENT, INCLUDING HISTOPATHOLOGICAL EXAMINATION OF THE VALVE TISSUE COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. NO IMPLANT RELATED FACTORS COULD BE CONFIRMED FROM THE INFORMATION RECEIVED FROM THE FIELD AS INFORMATION RELATED TO IMPLANT PROCEDURE WAS NOT PROVIDED. BIOLOGICAL FACTORS AS CALCIFICATION (FROM PATIENT CONDITIONS PREDISPOSING TO ELEVATED CALCIUM LIKE RENAL DISEASE ETC.), IMMOBILIZING THROMBUS, OR PANNUS FORMATION REDUCING THE VALVE DIAMETER ALSO COULD NOT BE CONFIRMED AS THE VALVE WAS NOT RETURNED FOR HISTOPATHOLOGICAL EXAMINATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    A MEDWATCH EMAIL WAS RECEIVED ON 30 AUGUST 2023, REPORTING THE INCIDENT WITH E100-25M-00 AND TFGT-21A . IT WAS REPORTED THAT A 25MM STENTED PORCINE,MIT,EPIC 25MM-00 AND 21MM TRIFECTA GT FINAL PACKAGE - WR WAS IMPLANTED IN A PATIENT ON (B)(6) 2018. ON AN UNKNOWN DATE AND YEAR, THE PATIENT WAS HOSPITALIZED REQUIRING INCREASE IN MEDICATION DUE TO HEART FAILURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) RESULTS SHOWED AORTIC VALVE: BIOPROSTHETIC AORTIC VALVE PRESENT. LEAFLETS ARE MOBILE, THERE WAS MODERATE TRANSVALVE AORTIC REGURGITATION . THE DI IS 0.41. AT IS 92MS. THE MG IS 28MMH MITRAL VALVE WELL SEATED, NO STENOSIS OR REGURGITATION. TEE REVEALS NORMAL RIGHT VENTRICULAR/LEFT VENTRICULAR FUNCTION AND NORMAL WASH OUT JET. NO PARAVALVULAR LEAK (PVL). THE BIOPROSTHETIC TRIFECTA AORTIC VALVE HAS MILD DEGENERATION CHANGES WITH NO STENOSIS, HOWEVER HAS MODERATE AORTIC REGURGITATION AND ALSO PATIENT PROSTHESIS PRESENT. NEED TO SWITCH TO COUMADIN DUE TO VALVULAR ATRIAL FIBRILLATION (AF), WITH LOCAL CARDIOLOGIST. POTENTIAL MISMATCH OF THE DEVICE. PATIENT STATUS IS UNKNOWN REFERENCE REPORT: MW5120624.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036622 TRIFECTA¿ GT VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL 5928344 05415067018212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization