BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DELIVERY CATHETER SYSTEM

    MDR report key: 15843993 · Received November 21, 2022

    Report

    Report Number
    MW5113407
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 17, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION / COREVALVE, LLC.
    Product Code
    NPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIAL PLACEMENT OF TRANSCATHETER AORTIC VALVE WENT WELL WITH GOOD POSITION AT 3 MM DEEP TO THE ANNULUS. WHILE RETRIEVING THE DEPLOYMENT DEVICE, THE VALVE WAS SNAGGED BY THE TIP OF THE CONE AND JUMPED OUT OF THE ANNULUS. WE ATTEMPTED PLACEMENT OF AN ADDITIONAL TRANSCATHETER VALVE. ON OUR THIRD DEPLOYMENT ATTEMPT, THE VALVE SPONTANEOUSLY DEPLOYED FROM THE DEVICE LANDING 7 TO 10 MM DEEP ON THE NONCORONARY CUSP. THIS VALVE DOVE DEEP INTO THE VENTRICLE. PATIENT HAD MODERATE AORTIC REGURGITATION AROUND THE CAGE WITH HEMODYNAMIC LABILITY. PATIENT UNDERWENT REMOVAL OF TRANS CATHETER VALVE AND SURGICAL AORTIC VALVE REPLACEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369000 EVOLUT FX DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION / COREVALVE, LLC. D-EVOLUTFX-2329 0011404213

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H