BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA STENTED TISSUE VALVE

    MDR report key: 12037592 · Received June 21, 2021

    Report

    Report Number
    3014918977-2021-00019
    Event Type
    Injury
    Date Received
    June 21, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, VALVE-IN--VALVES WERE PERFORMED TO REPLACE TRIFECTA VALVES DUE TO VALVE DETERIORATION, STENOSIS, REGURGITATION, PATIENT PROSTHESIS MISMATCH AND CALCIFICATION. 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.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 3001883144-2021-00096. THE ARTICLE, "BIOPROSTHETIC VALVE FRACTURE: PREDICTORS OF OUTCOME AND FOLLOW-UP. RESULTS FROM A MULTICENTER STUDY", WAS REVIEWED. THIS RESEARCH ARTICLE IS A OBSERVATIONAL MULTI-CENTER EXPERIENCE TO EVALUATE OUTCOME AND ITS PREDICTORS OF BIOPROSTHETIC VALVE FRACTURE (BVF) IN PATIENTS UNDERGOING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV-TAVR). MITROFLOW (SORIN GROUP USA INC), MOSAIC AND EVOLUT R/PRO(MEDTRONIC), MAGNA, PERIMOUNT AND SAPIEN 3(EDWARDS LIFESCIENCES), EPIC ,TRIFECTA AND PORTICO(ABBOTT), ALLEGRA(NEW VALVE TECHNOLOGY), ACURATE NEO(BOSTON SCIENTIFIC), CE STANDARD AND J-VALVES WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT BVF IS SAFE AND CAN SIGNIFICANTLY REDUCE GRADIENTS, WHICH REMAIN STABLE AT FOLLOW UP. THE PRIMARY AUTHOR OF THE ARTICLE IS CHRISTINA BRINKMANN MD, MVZ DEPARTMENT STRUCTURAL HEART DISEASE, ASKLEPIOS ST. GEORG, (B)(6). THE CORRESPONDENCE AUTHOR OF THE ARTICLE IS JOACHIM SCHOFER MD, PHD MVZ DEPARTMENT STRUCTURAL HEART DISEASE, ASKLEPIOS ST. GEORG WÖRDEMANNS WEG 25 ¿ 27 22527 (B)(6) WITH THE CORRESPONDING EMAIL: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933630 TRIFECTA STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention