BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 6979459 · Received October 26, 2017

    Report

    Report Number
    2025587-2017-01923
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    August 2, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHALLA, A. DR. PERCUTANEOUS VALVE IN VALVE IN THE TRICUSPID POSITION IN A PATIENT WITH TETRALOGY OF FALLOT. BMJ CASE REPORTS (2017) DOI 10.1136/BCR-2017-221104. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6)-OLD FEMALE WITH A MEDICAL HISTORY OF A PREVIOUSLY REPAIRED TETRALOGY OF FALLOT AND TRICUSPID REPAIR WITH A NON-MEDTRONIC RING. EIGHT YEARS LATER, A MEDTRONIC SURGICAL BIOPROSTHETIC MOSAIC VALVE WAS IMPLANTED INTO THE TRICUSPID POSITION. THREE YEARS AFTER THE IMPLANT, SEVERE STENOSIS WITH INCREASED GRADIENT MEASUREMENTS, AND MILD REGURGITATION WERE NOTED. SUBSEQUENTLY, A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED, VALVE-IN-VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760402 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention