BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 23991331 · Received January 7, 2026

    Report

    Report Number
    9612164-2026-00092
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 30, 2025
    Report Date
    March 16, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000944476
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H.6 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.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. H6. ADDITIONAL CODES. H6. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: EVFXPLUS-34; PRODUCT LOT/SERIAL NUMBER: R202918; PRODUCT TYPE: HEART VALVES; IMPLANT DATE: N/A; EXPLANT DATE: N/A PRODUCT ID: EVFXPLUS-34; PRODUCT LOT/SERIAL NUMBER: R203070; PRODUCT TYPE: HEART VALVES; IMPLANT DATE: N/A; EXPLANT DATE: N/A. 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

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT A MISLOAD OCCURRED; HOWEVER, THE LOADER WAS EXPERIENCED. ADDITIONALLY, THERE WAS A PROCEDURAL DELAY OF APPROXIMATELY 15 MINUTES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR A TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE USING A 34 MM EVOLUT FX+ SYSTEM, THE VALVE INFLOW CROWN BENT BACKWARDS WHEN THE LOADER HAD NOT NOTICED THAT THE VALVE MOVED AWAY FROM THE BACKPLATE DURING THE CRIMPING STAGE OF LOADING. THE VALVE WAS REMOVED FROM THE DELIVERY CATHETER SYSTEM (DCS) AND WAS EXCHANGED FOR A NEW 34 MM VALVE, WHICH WAS THEN LOADED INTO THE SAME DCS AND LOADING KIT. ALTHOUGH LOADING WAS SMOOTH, A SHARP METAL PROTRUSION WAS DETECTED ALONG THE DCS DURING VISUAL INSPECTION PRIOR TO SCREENING. FLUOROSCOPIC INSPECTION WAS PERFORMED, BUT THE METAL PROTRUSION DID NOT APPEAR ON IMAGING. ACCORDING TO THE REPORTER, IT WAS THOUGHT THAT THE METAL PROTRUSION MAY HAVE BEEN DUE TO THE SECOND VALVE PUNCTURING THROUGH THE DCS, BUT UPON RELEASING THE VALVE TO INSPECT, THE METAL WAS STILL PROTRUDING WHEN THE VALVE HAD BEEN REMOVED. SUBSEQUENTLY, THE ENTIRE SYSTEM WAS REJECTED AND DISCARDED. A NEW 34 MM VALVE, DCS, AND LOADING KIT WERE LOADED SMOOTHLY AND USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53626 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-34 0013102637 00763000944476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown