BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 23391663 · Received October 27, 2025

    Report

    Report Number
    2025587-2025-05839
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    January 23, 2025
    Report Date
    October 27, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FRANCESCO NAPPI., ET AL.. TRANSLOCATED ANTERIOR MITRAL LEAFLET SPARING IS A VIABLE TREATMENT OPTION FOR BOTH DEGENERATIVE AND FUNCTIONAL MITRAL VALVE DISEASE. THE JOURNAL OF THORACIC DISEASE 17(2):707-723 2025. 10.21037/JTD-24-1555 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 TRANSLOCATED ANTERIOR MITRAL LEAFLET SPARING AS A VIABLE TREATMENT OPTION FOR BOTH DEGENERATIVE AND FUNCTIONAL MITRAL VALVE DISEASE. THE STUDY POPULATION INCLUDED 161 PATIENTS WHO WERE PREDOMINANTLY MALES WITH A MEAN AGE OF 72.52 ± 10.36 YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 12 PATIENTS WERE IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: LEFT VENTRICULAR EJECTION FRACTION (LVEF) BELOW 50%, ACUTE KIDNEY INJURY, RESPIRATORY FAILURE, ATRIAL FIBRILLATION, SEPSIS, STROKE¸ MAJOR ADVERSE CARDIOVASCULAR AND CEREBROVASCULAR EVENTS, ACUTE MYOCARDIAL INFARCTION, WORSENING NEW YORK HEAR ASSOCIATION (NYHA) CLASS, MITRAL VALVE REOPERATION AND HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793706 MOSAIC MITRAL BIOPROSTHETIC VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening| H| R