BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA¿ GT VALVE

    MDR report key: 17684724 · Received September 5, 2023

    Report

    Report Number
    2135147-2023-03856
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 5, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05415067018229
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE: CASE SERIES OF EARLY STRUCTURAL VALVE DETERIORATION OF TRIFECTA BIOPROSTHESIS - NEW ZEALAND EXPERIENCE. AS REPORTED IN A RESEARCH ARTICLE, AN EVENT OF AORTIC REGURGITATION WAS REPORTED. 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. USING THE DEVICE IN A POSITION NOT RECOMMENDED IN THE INSTRUCTIONS FOR USE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE ARTICLE, "CASE SERIES OF EARLY STRUCTURAL VALVE DETERIORATION OF TRIFECTA BIOPROSTHESIS - NEW ZEALAND EXPERIENCE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 75-YEAR-OLD MALE WITH NO REPORTED COMORBIDITIES. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2012, A 23MM TRIFECTA VALVE WAS IMPLANTED IN THE PATIENT. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH AORTIC REGURGITATION. A DECISION WAS MADE TO EXPLANT THE VALVE ON AN UNKNOWN DATE IN 2018, 72 MONTHS FOLLOWING THE FIRST IMPLANT PROCEDURE. THE ARTICLE CONCLUDED THE TRIFECTA VALVE HAS AN ACCEPTABLE SAFETY PROFILE AND OFFERS GOOD HEMODYNAMICS DUE TO THE EXTERNALLY MOUNTED LEAFLETS. HOWEVER, THEIR EXPERIENCE OF EARLY SVD AND FAILURE IS CONCERNING FOR VALVE DURABILITY. FURTHER COMPARISON TO OTHER BIOPROSTHETIC VALVES AND LONGER TERM FOLLOW-UP ARE REQUIRED TO CHARACTERIZE THE MECHANISM OF FAILURES. [(B)(6)]. POST-PROCEDURAL COMPLICATIONS INCLUDED: AORTIC REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION *PATIENT 8*.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007233 TRIFECTA¿ GT VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL 05415067018229

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R