BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 23412675 · Received October 29, 2025

    Report

    Report Number
    2025587-2025-05854
    Event Type
    Death
    Date Received
    October 29, 2025
    Date of Event
    April 12, 2024
    Report Date
    October 29, 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: GUILLAUME GUIMBRETIÈRE., ET AL.. CALCIFICATION OF SURGICAL AORTIC BIOPROSTHESES AND ITS IMPACT ON CLINICAL OUTCOME. EUROPEAN HEART JOURNAL - CARDIOVASCULAR IMAGING 25, 1226¿1234 2024. 10.1093/EHJCI/JEAE100 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 CALCIFICATION OF SURGICAL AORTIC BIOPROSTHESES AND ITS IMPACT ON CLINICAL OUTCOME. THE STUDY POPULATION INCLUDED 342 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 77.2 ± (B)(6) YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 16 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: SEVERE PATIENT PROSTHESIS MISMATCH, STRUCTURAL VALVE DETERIORATION, STENOSIS, REGURGITATION, HEART FAILURE, LEAFLET THICKENING AND/OR LIMITATION OF MOTION, LEAFLET TEAR/PROLAPSE, CALCIFICATION AND INCREASED GRADIENTS. IT WAS REPORTED THAT 44 PATIENTS RECEIVED MEDICAL TREATMENT, 64 PATIENTS UNDERWENT REDO-SURGERY, AND 75 PATIENTS HAD A TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MOSAIC VALVES WERE IMPLANTED IN THE AORTIC POSITION. IT WAS STATED THAT 1 PATIENT WAS IMPLANTED WITH A 19MM VALVE SIZE, 5 PATIENTS WITH 21MM, 7 PATIENTS WITH 23MM, 2 PATIENTS WITH 27MM AND 1 PATIENT WITH 25MM. IT WAS REPORTED THAT 11 PATIENTS IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE DEMONSTRATED SIGN OF STRUCTURAL VALVE DETERIORATION WITH A MEAN DELAY FROM SURGERY OF 9.6+-2.5 YEARS, 3 PATIENTS UNDERWENT REDO-SURGERY, AND 6 PATIENTS HAD A TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE. IT WAS REPORTED THAT 4 PATIENTS IMPLANTED WITH MOSAIC VALVE DIED DURING THE STUDY PERIOD, INCLUDING 2 PATIENTS WITH STRUCTURAL VALVE DETERIORATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212269 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death