BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7245982 · Received February 6, 2018

    Report

    Report Number
    2025587-2018-00308
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    November 11, 2017
    Report Date
    February 6, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YAMASHITA K TRANSCATHETER AORTIC VALVE IMPLANTATION FOR DEGENERATED 19-MM AORTIC BIOPROSTHETIC VALVE. CIRC J 2018; 82: 289 ¿ 292 DOI: 10.1253/CIRCJ.CJ-17-0851 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING TRANSCATHETER AORTIC VALVE IMPLANTATION FOR DEGENERATED 19-MM AORTIC BIOPROSTHETIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN DECEMBER 2016 AND MARCH 2017. THE STUDY POPULATION INCLUDED 3 PATIENTS ALL FEMALE; ONE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE IN THE AORTIC AND MITRAL POSITIONS. THE SERIAL NUMBER WERE NOT PROVIDED. MEDTRONIC RECEIVED INFORMATION THAT (B)(6) FEMALE PATIENT HAD BEEN IMPLANTED WITH A 19 MM MOSAIC BIOPROSTHETIC VALVE IN AORTIC POSITION. SIX YEARS SEVEN-MONTHS POST IMPLANT, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO INCREASED GRADIENT (MMHG) OF 53 MM HG, SEVERE STENOSIS AND MODERATE INSUFFICIENCY OF THE AORTIC PROSTHETIC VALVE. THERE WAS REPORTEDLY NORMAL FUNCTION OF THE MOSAIC MITRAL BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88088 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention