BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT¿ FX+

    MDR report key: 23412924 · Received October 29, 2025

    Report

    Report Number
    23412924
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SCHEDULED TO RECEIVE A TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] VALVE AND WAS BROUGHT TO THE HYBRID ROOM FOR THE PROCEDURE. THE INITIAL PORTION WENT WITHOUT INCIDENT, AND THE VALVE WAS DEPLOYED IN THE EXISTING SAVR [SURGICAL AORTIC VALVE REPLACEMENT] VALVE. AFTER DEPLOYMENT IT WAS DETERMINED THAT THE VALVE SHOULD BE POST DILATED. A BALLOON WAS INSERTED TO POST DILATE THE VALVE. DURING THIS PROCESS THE VALVE POPPED UP INTO THE ASCENDING AORTA REQUIRING A NEW VALVE TO BE DEPLOYED. THE VALVE THAT POPPED UP WAS LEFT IN THE PATIENT AS THERE WAS NO WAY TO SAFELY REMOVE THE MIS-DEPLOYED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219193 EVOLUT¿ FX+ AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE LLC EVFXPLUS-26 K125466

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female