BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 11016791 · Received December 16, 2020

    Report

    Report Number
    2025587-2020-03813
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    July 1, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GONG F., ET AL. OPTIMAL IMAGING GUIDANCE DURING TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT IN BIOPROSTHESES WITH RADIOLUCENT SEWING RINGS. J AM COLL CARDIOL CASE REP., 2020 JULY; 2(8):1129¿1134. DOI.ORG/10.1016/J.JACCAS.2020.05.073. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE). 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 OF A CASE REPORT REGARDING OPTIMAL IMAGING GUIDANCE FOR VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE REPLACEMENT (VIV TMVR). A (B)(6)-YEAR-OLD FEMALE PATIENT WITH RHEUMATIC HEART DISEASE, STROKE, CORONARY ARTERY DISEASE AND ATRIAL FIBRILLATION HAD UNDERGONE PRIOR MECHANICAL AORTIC VALVE REPLACEMENT, CORONARY ARTERY BYPASS GRAFTING (CABG), BIOPROSTHETIC AORTIC/MITRAL VALVE REPLACEMENTS AND DEFIBRILLATOR IMPLANTATION. SHE WAS HOSPITALIZED WITH A ONE-YEAR HISTORY OF RECURRENT HEART FAILURE HOSPITALIZATIONS. TTE/TEE REVEALED SEVERE MITRAL REGURGITATION WITH SEVERE PULMONARY HYPERTENSION DUE TO PROLAPSE AND A FLAIL LEAFLET INVOLVING THE 25-MM MEDTRONIC MOSAIC VALVE (NO SERIAL NUMBER PROVIDED). THE PATIENT UNDERWENT VIV TMVR USING A NON-MEDTRONIC VALVE WITHOUT COMPLICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480741 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 310-25

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R