BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 23404512 · Received October 28, 2025

    Report

    Report Number
    2025587-2025-05847
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    November 14, 2024
    Report Date
    October 28, 2025
    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: GABRIELLE AMAR., ET AL.. TRANSCATHETER VACUUM-ASSISTED MASS EXTRACTION ON A MITRAL BIOPROSTHESIS. THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 5 :(30) 103084 2025. 10.1016/J.JACCAS.2024.103084 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 AN 84-YEAR-OLD FEMALE PATIENT WHO UNDERWENT VALVE REPLACEMENT USING A MEDTRONIC 27MM MOSAIC MITRAL BIOPROSTHETIC VALVE. IT WAS REPORTED THAT POSTOPERATIVELY, THE PATIENT REQUIRED PACEMAKER IMPLANTATION DUE TO COMPLETE HEART BLOCK. IT WAS STATED THAT THE PATIENT PRESENTED WITH MALAISE AND PROGRESSIVE SHORTNESS OF BREATH, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PERFORMED REVEALED A REDUCED LEFT VENTRICULAR EJECTION FRACTION OF 10% TO 15% AND A FLOATING MASS ON THE MITRAL PROSTHESIS. THERE WAS TRACE MITRAL REGURGITATION WITH NO PERIVALVULAR LEAKAGE. THE PATIENT WAS SUSPECTED OF HAVING BIOPROSTHETIC ENDOCARDITIS, ALTHOUGH THE PATIENT HAD BEEN AFEBRILE WITH NEGATIVE BLOOD CULTURES. A MINIMALLY INVASIVE PROCEDURE WAS PERFORMED, 2 PIECES OF THE INTRACARDIAC MASS WERE EXTRACTED. IT WAS REPORTED THAT THE PATHOLOGIC EXAMINATION WAS CONSISTENT WITH ABUNDANT FIBRIN WITH INFLAMMATION AND FIBROBLASTIC REACTION. IT WAS STATED THAT THE POSTPROCEDURAL COURSE WAS UNEVENTFUL AND FOLLOW-UP ECHOCARDIOGRAPHY REVEALED A WELL-FUNCTIONING MITRAL BIOPROSTHETIC WITHOUT VISIBLE MASS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173323 MOSAIC MITRAL BIOPROSTHETIC VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Life Threatening| R| H