BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 9885309 · Received March 26, 2020

    Report

    Report Number
    2025587-2020-00969
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    April 28, 2019
    Report Date
    March 26, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PAPARELLA D ET AL. MINIMALLY INVASIVE SURGICAL VERSUS TRANSCATHETER AORTIC VALVE REPLACEMENT: A MULTICENTER STUDY. INT J C ARDIOL HEART VASC. 2019 APR 28;23:100362. DOI: 10.1016/J.IJCHA.2019.100362. EARLIEST DATE OF PUBLISH USED FOR EVENT 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 THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). 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 COMPARISON OF THE OUTCOMES IN PATIENTS WHO EITHER UNDERWENT MINIMALLY INVASIVE SURGICAL AORTIC VALVE REPLACEMENT (MINI-SAVR) OR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM TEN CENTERS BETWEEN JANUARY 2011 AND DECEMBER 2016. THE OVERALL STUDY POPULATION INCLUDED 2,904 PATIENTS (2,407 MINI-SAVR; 497 TAVI) AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 74 YEARS. OF THOSE, 453 WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER AORTIC VALVES AND AN UNIDENTIFIED NUMBER OF MINI-SAVR PATIENTS WERE IMPLANTED WITH MEDTRONIC HANCOCK II OR MOSAIC SURGICAL AORTIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE 30-DAY MORTALITY RATE WAS 1.8% (51 PATIENTS). MULTIPLE MANUFACTURERS WERE INVOLVED IN THE STUDY AND NO FURTHER DETAILS ABOUT THE DEATHS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, STROKE (DISABLING OR NON-DISABLING), REOPENING FOR BL EEDING/COMPLICATIONS, WOUND INFECTION, ATRIAL FIBRILLATION, RE-INTUBATION, TRACHEOSTOMY, BLOOD TRANSFUSION, AND LOW CARDIAC OUTPUT. BASED ON THE AVAILABLE INFORMATION, 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
    349316 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention