BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 6641318 · Received June 14, 2017

    Report

    Report Number
    2025587-2017-00970
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    February 25, 2016
    Report Date
    May 31, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GHOBRIAL J, ABOULHOSN J. IMPACT OF RIGHT-SIDED-CATHETER-BASED VALVE IMPLANTATION ON DECISION-MAKING IN CONGENITAL HEART DISEASE. CURR CARDIOL REP. 2016 APR;18(4):33. DOI: 10.1007/S11886-016-0712-2. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE META-ANALYSIS OF A PATIENT WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED) IN THE TRICUSPID POSITION WHO UNDERWENT A VALVE-IN-VALVE IMPLANT OF A NON-MEDTRONIC TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422119 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention