BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 11027689 · Received December 17, 2020

    Report

    Report Number
    2025587-2020-03839
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    June 11, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SAFI L., ET AL. NOVEL USE OF ECHO FUSION AND CARDIAC COMPUTED TOMOGRAPHIC IMAGING GUIDANCE FOR PERCUTANEOUS PARAVALVULAR LEAK CLOSURE. CASE (PHILADELPHIA), 2020 AUG; 4(4):303¿310. PUBLISHED ONLINE 2020 JUN 11. DOI: 10.1016/J.CASE.2020.05.006. PMID: 32875200. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 REGARDING A (B)(6)-YEAR-OLD FEMALE PATIENT WITH CORONARY ARTERY DISEASE, MITRAL VALVE PROLAPSE WITH SEVERE REGURGITATION WHO UNDERWENT CONCOMITANT CORONARY ARTERY BYPASS GRAFTING (CABG) AND SURGICAL MITRAL VALVE REPLACEMENT (SMVR) USING A 25-MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVE IN DECEMBER 2018 (NO SERIAL NUMBERS PROVIDED). EIGHT MONTHS POST-IMPLANT, THE PATIENT WAS HOSPITALIZED WITH UNINTENTIONAL WEIGHT LOSS, FAILURE-TO-THRIVE, PROGRESSIVE DYSPNEA, LOUD SYSTOLIC MURMUR AND LABORATORY EVIDENCE OF HEMOLYSIS. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED ECCENTRIC SEVERE MITRAL PARAVALVULAR LEAK (PVL) WITH TRIVIAL MITRAL VALVE REGURGITATION AND ELEVATED PULMONARY ARTERY PRESSURE. IT WAS SUSPECTED THAT SUTURE DEHISCENCE HAD LED TO PVL. TRANSTHORACIC PERCUTANEOUS CLOSURE WAS PERFORMED UNDER COMBINED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE)/ COMPUTERIZED TOMOGRAPHY (CT) GUIDANCE. AFTER CLOSURE WAS COMPLETED, TEE SHOWED RESIDUAL TRACE PVL WITH IMPROVED PULMONARY HEMODYNAMICS AND HEMOLYSIS PARAMETERS SUBSEQUENTLY IMPROVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494215 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 310-25

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R| S