BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 22587604 · Received July 24, 2025

    Report

    Report Number
    2025587-2025-05242
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    December 11, 2024
    Report Date
    July 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: VASU NANDHAKUMAR., ET AL.. PROSTHETIC HEART VALVE INTERACTIONS AND THEIR CLINICAL SIGNIFICANCE DURING TRANSCATHETER LEFT-SIDED DOUBLE VALVE REPLACEMENT. THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 30:103673 2025. 10.1016/J.JACCAS.2025.103673 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 61-YEAR-OLD MALE PATIENT WHO UNDERWENT MITRAL VALVE REPLACEMENT WITH A MEDTRONIC 25MM MOSAIC BIO PROSTHETIC VALVE. IT WAS REPORTED THAT POST IMPLANT, SEVERE INTRAPROSTHETIC VALVULAR LEAK AND FIRST-DEGREE AV BLOCK WERE NOTED. A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221216 MOSAIC REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 305U25

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R| L