BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 24741107 · Received March 31, 2026

    Report

    Report Number
    2025587-2026-00362
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    October 22, 2025
    Report Date
    March 31, 2026
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KATHLEEN R. KHAN., ET AL.. SURGICAL REINTERVENTION FOR COMPLEX, MULTIVALVULAR RHEUMATIC HEART DISEASE. THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 30;30:104356 2025. 10.1016/J.JACCAS.2025.104356. 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 A 52-YEAR-OLD FEMALE PATIENT WHO UNDERWENT AORTIC VALVE REPLACEMENT USING A MEDTRONIC 21MM FREESTYLE BIOPROSTHETIC VALVE. IT WAS REPORTED THAT POST IMPLANT, A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) PERFORMED REVEALED AORTIC STENOSIS, SEVERE BIOPROSTHETIC AORTIC VALVE REGURGITATION WITH A FLAIL ANTERIOR CUSP, ELEVATED GRADIENTS ACROSS THE BIOPROSTHETIC VALVE AND THE PROSTHESIS WAS HEAVILY CALCIFIED. THE VALVE WAS EXPLANTED AND REPLACED WITH NON-MEDTRONIC VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798898 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Life Threatening| H| R