BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 11027399 · Received December 17, 2020

    Report

    Report Number
    2025587-2020-03838
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    June 16, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YOSHIKAWA, YASUSHI ET AL. LONG-TERM OUTCOMES OF THE MOSAIC AORTIC PORCINE BIOPROSTHESIS IN JAPAN: RESULTS FROM THE JAPAN MOSAIC VALVE LONG-TERM MULTICENTER STUDY. CIRCULATION JOURNAL. 2020; 84:1261-1270. DOI: 10.1253/CIRCJ.CJ-19-1113. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MOSAIC BIOPROSTHETIC AORTIC VALVE (PMA# P990064, PRODUCT CODE DYE). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER SERIAL 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 LONG-TERM OUTCOMES AFTER THE IMPLANT OF MOSAIC BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A RETROSPECTIVE REVIEW OF IMPLANTS FROM 10 (B)(6) MEDICAL CENTERS BETWEEN 1999 AND 2014. THE STUDY POPULATION INCLUDED 1,202 PATIENTS (PREDOMINANTLY FEMALE, MEDIAN AGE 76 YEARS). NO SERIAL NUMBERS WERE REPORTED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: THROMBOSIS, STENOSIS, ENDOCARDITIS, PARAVALVULAR LEAK (PVL), CALCIFICATION, LEAFLET TEAR, LIMITED LEAFLET OPENING, EMBOLISM, INCREASED GRADIENT MEASUREMENTS BLEEDING. IT WAS REPORTED THAT SOME ADVERSE EVENTS WERE TREATED WITH VALVE EXPLANT OR REOPERATION. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497552 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention