BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 14107445 · Received April 13, 2022

    Report

    Report Number
    2025587-2022-00977
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    September 15, 2021
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YOSHIKAWA ET AL. LONG-TERM OUTCOMES OF THE MOSAIC MITRAL PORCINE BIOPROSTHESIS IN JAPAN: RESULTS FROM THE JAPAN MOSAIC VALVE LONG-TERM MULTICENTER STUDY. CIRC J. 2022 FEB 25;86(3):449-457. DOI: 10.1253/CIRCJ.CJ-21-0528. EPUB 2021 SEP 15. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LONG-TERM OUTCOMES OF THE MOSAIC MITRAL PORCINE BIOPROSTHESIS IN JAPAN. ALL DATA WERE COLLECTED FROM MULTIPLE JAPANESE CENTERS BETWEEN 1999 AND 2014. THE STUDY POPULATION INCLUDED 390 PATIENTS (PREDOMINANTLY FEMALE, MEDIAN AGE 73 YEARS). ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, THERE WERE 105 DEATHS DURING THE STUDY PERIOD. THE EARLY MORTALITY RATE WAS 5.4% (N=21) AND LATE MORTALITY RATE WAS 21.5% (N=84). OF THE 105 DEATHS THAT OCCURRED, 39 WERE CARDIAC, 51 WERE NON-CARDIAC, AND 15 WERE DUE TO UNKNOWN CAUSES. OF THE 39 CARDIAC DEATHS, 6 WERE DEEMED VALVE-RELATED. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: THROMBO-EMBOLIC EVENTS; BLEEDING EVENTS; REOPERATIONS WERE PERFORMED FOR STRUCTURAL VALVE DYSFUNCTION (SVD), PARAVALVULAR LEAK (PVL), AND ENDOCARDITIS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708940 MOSAIC MITRAL BIOPROSTHETIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Life Threatening| R| H