BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 23386635 · Received October 25, 2025

    Report

    Report Number
    2025587-2025-05838
    Event Type
    Injury
    Date Received
    October 25, 2025
    Date of Event
    February 1, 2025
    Report Date
    October 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: VIKAS KILARU., ET AL.. TRICUSPID REGURGITATION COMPLICATING LEADLESS PACEMAKER IMPLANTATION: SURGICAL INTERVENTION FOR PACEMAKER REMOVAL AND TRICUSPID VALVE REPLACEMENT. ELSEVIER INC 11:108¿110 2025. 10.1016/J.HRCR.2024.10.017 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT (MONTH AND YEAR VALID). 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 85-YEAR-OLD FEMALE PATIENT WHO UNDERWENT VALVE REPLACEMENT USING A MEDTRONIC 33MM MOSAIC MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION. IT WAS REPORTED THAT POSTOPERATIVELY, THE PATIENT REQUIRED TEMPORARY VENTRICULAR PACING AND PLACEMENT OF A TRANSVENOUS PACING CATHETER DUE TO ATRIAL FIBRILLATION WITH SLOW VENTRICULAR RESPONSE. IT WAS STATED THAT WITHIN 5 DAYS POSTOPERATIVELY, THE PATIENT RECOVERED FROM ATRIOVENTRICULAR CONDUCTION. IT WAS REPORTED THAT THE PATIENT¿S HOSPITAL COURSE WAS COMPLICATED BY RESPIRATORY FAILURE REQUIRING REINTUBATION DUE TO CONGESTIVE HEART FAILURE, PLEURAL EFFUSION REQUIRING CHEST TUBE PLACEMENT, AGGRESSIVE DIURESIS AND INTERMITTENT INOTROPIC SUPPORT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028928 MOSAIC MITRAL BIOPROSTHETIC VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention