BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 13869586 · Received March 23, 2022

    Report

    Report Number
    2025587-2022-00777
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    February 16, 2022
    Report Date
    March 23, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: NEMSHAH Y., ET AL. UNEARTHING THE TUNNEL. JACC CASE REP. 2022 FEB 16;4(4):241-246. DOI: 10.1016/J.JACCAS.2021.12.021. PMID: (B)(4). EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WITH A PRIOR MEDICAL HISTORY OF CORONARY ARTERY BYPASS SURGERY, MITRAL VALVE REPAIR USING A MITRAL VALVE RING, BONE MARROW TRANSPLANT FOR MULTIPLE MYELOMA, AND OSTEOMYELITIS WITH CONCURRENT ANTIBIOTIC-RESISTANT BACTERIAL MITRAL VALVE ENDOCARDITIS. DUE TO THE ENDOCARDITIS, THE PATIENT DEVELOPED SEVERE MITRAL REGURGITATION (MR), REQUIRING RE-DO MITRAL VALVE SURGERY WITH IMPLANTATION OF A 25-MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). YEARS LATER, THE PATIENT WAS HOSPITALIZED WITH EVIDENCE OF WORSENING HEART FAILURE, INCLUDING DYSPNEA-ON-EXERTION/POOR FUNCTIONAL CAPACITY, SYSTOLIC MURMUR, LOWER EXTREMITY EDEMA ALONG WITH EVIDENCE OF HYPERBILIRUBINEMIA AND HEMATURIA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND CARDIAC COMPUTERIZED TOMOGRAPHY (CT) REVEALED A SEVERE PARAVALVULAR LEAK (PVL) AT THE LATERAL COMMISSURE OF THE MOSAIC IMPLANT. RIGHT HEART CATHETERIZATION INDICATED PULMONARY HYPERTENSION. THE PATIENT UNDERWENT PERCUTANEOUS CLOSURE OF THE PVL, WITH TRIVIAL RESIDUAL PVL REMAINING POST-PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950499 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R