BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23857789 · Received December 19, 2025

    Report

    Report Number
    9617601-2025-03645
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 16, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SERRUYS ET AL. 1-YEAR OUTCOMES OF NOVEL BALLOON-EXPANDABLE VS CONTEMPORARY TRANSCATHETER HEART VALVES IN SEVERE AORTIC STENOSIS: THE LANDMARK TRIAL. J AM COLL CARDIOL. 2025 NOV 16:S0735-1097(25)10159-9. DOI: 10.1016/J.JACC.2025.10.076.  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 OUTCOMES OF NOVEL BALLOON-EXPANDABLE VS CONTEMPORARY TRANSCATHETER HEART VALVES IN SEVERE AORTIC STENOSIS FROM THE LANDMARK CLINICAL TRIAL.  THE STUDY POPULATION INCLUDED 768 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 80.2 YEARS OLD.  THE PATIENTS WERE EQUALLY DIVIDED BETWEEN TWO GROUPS: MYVAL VALVE (N=384) AND CONTEMPORARY TRANSCATHETER VALVES (N=384).  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 192 PATIENTS WERE IMPLANTED WITH A MEDTRONIC DEVICE WHICH INCLUDED EVOLUT R, EVOLUT PRO, EVOLUT PRO+, AND EVOLUT FX BIOPROSTHETIC VALVES.   AMONG ALL PATIENTS, FOUR VALVE-RELATED DEATHS AND THREE ENDOCARDITIS-RELATED DEATHS OCCURRED.  NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS.  FOR THE REMAINING DEATHS THAT OCCURRED IN THE STUDY POPULATION, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: HIGH GRADIENTS; MODERATE TO SEVERE PARAVALVULAR LEAK; PATIENT-PROSTHESIS MISMATCH; STROKE; ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT; CONGESTIVE HEART FAILURE REQUIRING HOSPITALIZATION; VALVE THROMBOSIS; ENDOCARDITIS; AND STRUCTURAL VALVE DETERIORATION DEFINED AS WEAR AND TEAR, LEAFLET DISRUPTION, FLAIL LEAFLET, LEAFLET FIBROSIS AND/OR CALCIFICATION, OR STENT FRACTURE OR DEFORMATION.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345183 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H| L