BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 10203312 · Received June 26, 2020

    Report

    Report Number
    2025587-2020-02044
    Event Type
    Death
    Date Received
    June 26, 2020
    Date of Event
    October 11, 2019
    Report Date
    June 26, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LORUSSO R ET AL. MITRAL VALVE REPLACEMENT WITH A THIRD-GENERATION PORCINE VALVE: AN ITALIAN MULTICENTERED STUDY. ANNALS OF THORACIC SURGERY. 2020; 109:1865-1873. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.08.111 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A RETROSPECTIVE STUDY OF THE POSTOPERATIVE OUTCOMES IN PATIENTS UNDERGOING MITRAL VALVE REPAIR WITH A PORCINE-BASED BIOPROSTHESIS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 1998 AND DECEMBER 2011. THE STUDY POPULATION INCLUDED 805 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 74 YEARS, MEAN WEIGHT 67 KG), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC MOSAIC BIOPROSTHETIC MITRAL VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, IT WAS REPORTED THAT 63 DEATHS OCCURRED WITHIN 30 DAYS, 42 FROM CARDIAC CAUSES, 12 FROM MULTIORGAN FAILURE, 6 FROM SEPSIS, 2 FROM CEREBRAL BLEEDING, AND 1 FROM PULMONARY THROMBOEMBOLISM. THERE WERE 95 LATE DEATHS. IT WAS REPORTED THAT THE CUMULATIVE RATE OF CARDIAC-RELATED DEATHS WAS 1.6% AT 1 YEAR, 5.6% AT 5 YEARS, AND 7.4% AT 10 YEARS. THE CUMULATIVE RATE OF VALVE-RELATED DEATHS WAS 0.4% AT 1 YEAR, 1.1% AT 5 YEARS, AND 1.1% AT 10 YEARS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662322 MOSAIC MITRAL BIOPROSTHETIC VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death