BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23523299 · Received November 11, 2025

    Report

    Report Number
    9617601-2025-02626
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    April 24, 2025
    Report Date
    November 11, 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
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MENGI ET AL. TEMPORAL TRENDS IN TRANSCATHETER AORTIC VALVE REPLACEMENT OUTCOMES IN PATIENTS WITH LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS: INSIGHTS FROM THE TOPAS-TAVI REGISTRY. CAN J CARDIOL. 2025 AUG;41(8):1503-1514. DOI: 10.1016/J.CJCA.2025.04.015. EPUB 2025 APR 24. 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 TEMPORAL TRENDS IN TRANSCATHETER AORTIC VALVE REPLACEMENT OUTCOMES IN PATIENTS WITH LOW-FLOW, LOW- GRADIENT AORTIC STENOSIS. THE STUDY POPULATION INCLUDED 424 PATIENTS DIVIDED INTO TWO GROUPS: NEW (N=193) AND EARLY (N=231). MULTIPLE MANUFACTURERS¿ BIOPROSTHETIC VALVES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED COREVALVE (N=58) IN THE EARLY GROUP AND EVOLUT R, EVOLUT PRO OR EVOLUT FX (N=34) IN THE NEW GROUP. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: STROKE, MYOCARDIAL INFARCTION, MAJOR BLEEDING OR VASCULAR COMPLICATION, CORONARY OBSTRUCTION, ANNULUS RUPTURE, CARDIAC TAMPONADE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, CONGESTIVE HEART FAILURE REQUIRING HOSPITALIZATION, ELEVATED GRADIENTS OF 17 MMHG, MODERATE OR SEVERE PARAVALVULAR LEAK, MODERATE OR SEVERE CENTRAL AORTIC REGURGITATION, ENDOCARDITIS, AND CONVERSION TO OPEN SURGERY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901978 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 NA Unknown Hospitalization| L| R