BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 20737866 · Received November 20, 2024

    Report

    Report Number
    2025587-2024-06706
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    December 21, 2023
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: EUNJUNG CHOI, ET AL. PRECONCEPTION COUNSELING FOR A PATIENT WITH A MECHANICAL TRICUSPID VALVE. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 29(3):102159 2024. DOI.ORG/10.1016/J.JACCAS.2023.102159. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A 31-YEAR-OLD FEMALE PATIENT WHO UNDERWENT BIOPROSTHETIC TRICUSPID VALVE REPLACEMENT WITH A 29MM MEDTRONIC MOSAIC VALVE. IT WAS REPORTED THAT 2 YEARS LATER, THE PATIENT UNDERWENT REDO STERNOTOMY, THE VALVE WAS EXPLANTED AND REPLACED WITH MECHANICAL VALVE OF A DIFFERENT MANUFACTURER DUE TO EARLY DEGENERATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460437 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown Required Intervention| H