BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 20288177 · Received September 23, 2024

    Report

    Report Number
    2025587-2024-05296
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    March 31, 2024
    Report Date
    September 23, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HLAVICKA ET AL. MINIMALLY INVASIVE AND FULL STERNOTOMY AORTIC VALVE REPLACEMENTS LEAD TO COMPARABLE LONG-TERM OUTCOMES IN ELDERLY HIGHER-RISK PATIENTS: A PROPENSITY-MATCHED COMPARISON. JOURNAL OF CARDIOVASCULAR DEVELOPMENT AND DISEASE 11(4):112 2024. DO I.ORG/10.3390/JCDD11040112. 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 LONG-TERM OUTCOMES IN ELDERLY HIGH RISK PATIENTS UNDERGOING MINIMALLY INVASIVE OR FULL STERNOTOMY AORTIC VALVE REPLACEMENT. THE STUDY POPULATION INCLUDED 441 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 74 YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 66 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, ADVERSE EVENTS INCLUDED: CARDIAC TAMPONADE, STROKE, BLEEDING COMPLICATION, COMPLETE HEART BLOCK OR OTHER ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, RENAL FAILURE REQUIRING HEMODIALYSIS, LOW CARDIAC OUTPUT, UNSPECIFIED STRUCTURAL VALVE DYSFUNCTION, THROMBOSIS, THROMBO-EMBOLIC EVENT AT 8 YEARS POST-IMPLANT, AND PROSTHETIC VALVE ENDOCARDITIS AT 12 YEARS POST-IMPLANT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869273 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Life Threatening| R| H