BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 18148976 · Received November 16, 2023

    Report

    Report Number
    2135147-2023-05051
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    March 29, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05414734052016
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRIFECTA VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING UNKNOWN COMORBIDITIES. SOME OF THE COMPLICATIONS REPORTED WERE SEVERE TRANSVALVULAR AORTIC REGURGITATION, SURGICAL INTERVENTION FOR VALVE IN VALVE, STENT POST DEFORMATION, SERIOUS LEAFLET DAMAGE AND HOSPITALIZATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER HEART VALVE STUCK IN A SURGICAL BIOPROSTHESIS DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 77-YEAR-OLD MAN. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 19MM TRIFECTA VALVE WAS IMPLANTED. IT WAS LATER REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH SEVERE TRANSVALVULAR AORTIC REGURGITATION (AR) DUE TO STRUCTURAL VALVE DEGENERATION OF THE 19MM TRIFECTA VALVE. A DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE (VIV) PROCEDURE WITH A 23MM EVOLUT PRO+ (MEDTRONIC). PRE-PROCEDURAL MULTIDETECTOR COMPUTED TOMOGRAPHY (MDCT) NOTED THE TRIFECTA VALVE HAD BEEN OBLIQUELY IMPLANTED. DURING PROCEDURE, THE STENT POST OF THE TRIFECTA VALVE HAD PROTRUDED INTO THE EVOLUT PRO+ STRUT AND BECAME DEFORMED WHEN ATTEMPTING TO RESHEATH THE EVOLUT PRO+. THE EVOLUT PRO+ SYSTEM WAS FORCEFULLY WITHDRAWN FROM THE TRIFECTA WHICH RESULTED IN SERIOUS LEAFLET DAMAGE TO THE TRIFECTA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR TORRENTIAL AR. THE EVOLUT PRO+ VALVE WAS SUCCESSFULLY IMPLANTED DURING THE SECOND ATTEMPT AND HEMODYNAMICS WERE STABILIZED. THE ARTICLE CONCLUDED ATTENTION SHOULD BE PAID TO THE RISK OF THIS PHENOMENON DURING THE VIV-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), ESPECIALLY WHEN THEY ARE NOT COAXIAL. [THE PRIMARY AUTHOR WAS MASANORI KAWAGUCHI, CARDIOVASCULAR DEPARTMENT, SUWA RED CROSS HOSPITAL, 5-11-50 KOGANDORI, SUWA, 392-8510 NAGANO, JAPAN. THE CORRESPONDING AUTHOR WAS FUMIAKI YASHIMA, DEPARTMENT OF CARDIOLOGY, SAISEIKAI UTSUNOMIYA HOSPITAL, 911-1 TAKEBAYASHI-CHO, UTSUNOMIYA, 321-0974 TOCHIGI, JAPAN, WITH CORRESPONDING EMAIL: [email protected]]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237069 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL 05414734052016

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening| H| R