BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC EVOLUT FX 34MM SYSTEM

    MDR report key: 21847846 · Received April 16, 2025

    Report

    Report Number
    MW5169068
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 10, 2025
    Manufacturer
    MEDTRONIC, INC./MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PER MEDICAL RECORDS PATIENT UNDERWENT TRANSCATHETER VALVE REPLACEMENT WITH A MEDTRONIC 34MM EVOLUT FX WHICH UNFORTUNATELY EMBOLIZED TO THE ASCENDING AORTA AND RESULTED IN AN ACUTE AORTIC DISSECTION. THE MEDTRONIC TAVR VALVE WAS EXPLANTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109678 MEDTRONIC EVOLUT FX 34MM SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC, INC./MEDTRONIC HEART VALVES DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown