BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 23026718 · Received September 11, 2025

    Report

    Report Number
    2025587-2025-05645
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    June 18, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MAZNYCZKA ET AL. ACUTE FRACTURE OF A SELF-EXPANDING TRANSCATHETER AORTIC VALVE AFTER POSTDILATATION RESULTING IN STRUCTURAL VALVE DETERIORATION. JACC CARDIOVASC INTERV. 2025 AUG 25;18(16):2062-2063. DOI: 10.1016/J.JCIN.2025.05.005. EPUB 2025 JUN 18. 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 66-YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH A DEGENERATED NON-MEDTRONIC SURGICAL AORTIC VALVE. SUBSEQUENTLY, SHE UNDERWENT A VALVE-IN-VALVE IMPLANT OF A MEDTRONIC 26-MM EVOLUT R TRANSCATHETER BIOPROSTHETIC AORTIC VALVE INSIDE THE DEGENERATED SURGICAL VALVE. AFTER THE INITIAL PLACEMENT OF THE TRANSCATHETER VALVE, HIGH RESIDUAL TRANSVALVULAR GRADIENT AND MODERATE PARAVALVULAR LEAK (PVL) REQUIRED BALLOON DILATATION WHICH REDUCED THE GRADIENT TO 26 MM HG AND THE PVL TO MILD. AT THE TIME OF THE BALLOON DILATATION THE AUTHORS NOTED A PROMINENT OUTWARD PROTRUSION OF THE TRANSCATHETER VALVE FRAME ABOVE THE COMMISSURE POST OF THE SURGICAL VALVE. ONE MONTH LATER, A COMPUTED TOMOGRAPHY SCAN SHOWED A FRACTURE OF THE TRANSCATHETER VALVE FRAME BETWEEN THE THIRD AND FOURTH NODES. THE SUSPECTED MECHANISM OF THE STENT FRACTURE WAS THE TRANSCATHETER VALVE FRAME DEFORMATION AGAINST THE COMMISSURE POST OF THE SURGICAL VALVE. THE AUTHORS ANTICIPATED POTENTIAL LEAFLET COAPTATION ISSUES AND PREMATURE STRUCTURAL VALVE DYSFUNCTION (SVD); HOWEVER, NO INTERVENTION WAS PERFORMED AND MONITORING WAS CONTINUED. AT TWO YEARS POST-IMPLANT, AN ECHOCARDIOGRAPHY DEMONSTRATED MODERATE AORTIC REGURGITATION (AR). HOWEVER, AS THE PATIENT WAS ASYMPTOMATIC, NO INTERVENTION WAS UNDERTAKEN AND MONITORING WAS CONTINUED. AT THREE YEARS POST-IMPLANT, THE PATIENT PRESENTED WITH ACUTE DECOMPENSATION WITH SEVERE TRANSVALVULAR AR AND SEVERE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY TREATMENT WITH SUCCESSFUL IMPLANTATION OF A MEDTRONIC 23-MM EVOLUT FX+ TRANSCATHETER VALVE WITH A POSTPROCEDURAL MEAN TRANSVALVULAR GRADIENT OF 18 MM HG. THREE DAYS LATER THE PATIENT DISCHARGED HOME ASYMPTOMATIC. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365244 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H| L