BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 6996575 · Received November 2, 2017

    Report

    Report Number
    2025587-2017-02002
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 2, 2014
    Report Date
    November 2, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GODART, F MD. TRANSCATHETER TRICUSPID VALVE IMPLANTATION: A MULTICENTRE FRENCH STUDY. ARCHIVES OF CARDIOVASCULAR DISEASE (2014) 107, 583¿591 DOI DOI.ORG/10.1016/J.ACVD.2014.07.051 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING TRANSCATHETER TRICUSPID VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS AND A LITERATURE SEARCH IN PUBMED. ALL PATIENTS WERE IMPLANTED WITH EITHER A MELODY OR A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC VALVE IN A TRICUSPID VALVE-IN-VALVE PROCEDURE. SERIAL NUMBERS WERE NOT PROVIDED. ONE MALE (B)(6)-YEAR-OLD PATIENT HAD A PREVIOUSLY IMPLANTED MOSAIC THAT WAS REPLACED IN A VALVE-IN-VALVE PROCEDURE DUE TO TRICUSPID STENOSIS, INCREASED GRADIENT MEASUREMENTS AND REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775191 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention