BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 24104991 · Received January 16, 2026

    Report

    Report Number
    2025587-2026-00062
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    November 3, 2025
    Report Date
    January 16, 2026
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BOLJEVIC ET AL. SIMULTANEOUS TRANSCATHETER AORTIC VALVE REPLACEMENT AND ENDOVASCULAR AORTIC ANEURYSM REPAIR-THE FIRST CASE IN SERBIA. DIAGNOSTICS (BASEL). 2025 NOV 3;15(21):2785. DOI: 10.3390/DIAGNOSTICS15212785. 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 75-YEAR-OLD MALE PATIENT WITH SEVERE AORTIC STENOSIS (AS) AND AN ABDOMINAL AORTIC ANEURYSM. SUBSEQUENTLY, THE PATIENT UNDERWENT A DUAL PROCEDURE WHICH INCLUDED SUCCESSFUL IMPLANT OF A MEDTRONIC 34-MM EVOLUT R BIOPROSTHETIC VALVE IN THE AORTIC POSITION FOLLOWED BY AN ENDOVASCULAR ANEURYSM REPAIR WITH SATISFACTORY STENT GRAFT PLACEMENT. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED ON THE NINTH DAY. AT THE SCHEDULED OUTPATIENT FOLLOW-UP, THE PATIENT DEMONSTRATED CLINICAL IMPROVEMENT WITH AN ECHOCARDIOGRAPHIC ASSESSMENT THAT REVEALED A PEAK TRANSVALVULAR PRESSURE GRADIENT OF 22 MMHG WITH TRACE AORTIC REGURGITATION. AT THE SIX-MONTH FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A TYPE II ENDOLEAK ORIGINATING FROM THE LUMBAR ARTERY IN THE ABDOMEN. THE VASCULAR TEAM RECOMMENDED A CONSERVATIVE MANAGEMENT APPROACH WHERE THE ENDOLEAK WAS TREATED CONSERVATIVELY WITH REGULAR CLINICAL FOLLOW-UPS TO MONITOR FOR CHANGES OR PROGRESSION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158701 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization