BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 23562444 · Received November 14, 2025

    Report

    Report Number
    2025587-2025-05925
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    March 4, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: RAVN ET AL.. AORTIC ROOT REPLACEMENT PROCEDURES: A VALIDATION STUDY OF THE WESTERN DENMARK HEART REGISTRY FROM 1999 TO 2022. DIAGNOSTICS 15(611) 2025. 10.3390/DIAGNOSTICS15050611 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING AORTIC ROOT REPLACEMENT PROCEDURES: A VALIDATION STUDY OF THE WESTERN DENMARK HEART REGISTRY FROM 1999 TO 2022. THE STUDY POPULATION INCLUDED 847 PATIENTS. 52 PATIENTS WERE IMPLANTED WITH A MEDTRONIC FREESTYLE AORTIC BIOPROSTHETIC VALVE. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CENTRAL NERVOUS SYSTEM DAMAGE, STERNAL INFECTION, ARRHYTHMIA, ATRIAL FIBRILLATION, ATRIOVENTRICULAR BLOCK, RE-INTERVENTION DUE TO BLEEDING, REOPERATION FOR ISCHEMIA AND DIALYSIS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2829938 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R