BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 23648582 · Received November 25, 2025

    Report

    Report Number
    9617601-2025-03007
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 3, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0012779398); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-34 (K041474); PRODUCT TYPE: 0195-HEART VALVES; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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

    IMAGE REVIEW: NINE IMAGES OF THE EVENT REPORTED WERE PROVIDED. TWO IMAGES OF THE COMPUTED TOMOGRAPHY (CT) SCAN SUMMARY SHOWING CA+ WAS PROVIDED. THERE WERE NO FULL CT OR EXECUTIVE SUMMARY PROVIDED OR ANATOMICAL CONSIDERATIONS. IT WAS REPORTED THAT FLUOROSCOPIC IMAGES OF THE VALVE LOAD CONFIRMED THE VALVE WAS LOADED PROPERLY. EVIDENCE SHOWS FLUOROSCOPIC IMAGE OF THE VALVE LOAD; HOWEVER, THE VALVE IS NOT ROTATED 360 DEGREES, THEREFORE IT CANNOT BE CONFIRMED THE VALVE WAS LOADED PROPERLY. POSITION THE CAPSULE FLAT ON AN AREA THAT WILL NOT IMPEDE CLARITY OF THE DEVICE, SLOWLY ROTATE THE CAPSULE 360° AND INSPECT THE VALVE FOR ANY INDICATIONS OF A MISLOAD. IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED USING A 24 MILLIMETER BALLOON. IT WAS REPORTED THAT DURING THE FIRST IMPLANTATION ATTEMPT WITH THE INITIAL VALVE, THE PROSTHESIS APPEARED UNDER EXPANDED WITH A POSSIBLE INFOLDING. EVIDENCE SUPPORTS AN UNDER-EXPANDED VALVE WITH A POSSIBLE INFOLD. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE TO A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND NOT USED. IT WAS THEN REPORTED THAT A NEW VALVE WAS LOADED, AND FLUOROSCOPY CONFIRMED CORRECT LOADING. THE VALVE WAS THEN RELEASED WITHOUT COMPLICATIONS. UPDATED DATA: B5. H6. 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

    IT WAS REPORTED THAT DURING A PROCEDURE FOR HEAVILY CALCIFIED AORTIC VALVE STENOSIS, A PRE-DILATATION WAS PERFORMED USING A 24 MILLIMETER BALLOON. FLUOROSCOPIC IMAGING CONFIRMED THAT THE TRANSCATHETER AORTIC VALVE  WAS PROPERLY LOADED. DURING THE FIRST IMPLANTATION ATTEMPT WITH THE INITIAL VALVE, THE PROSTHESIS APPEARED UNDER-EXPANDED WITH A POSSIBLE INFOLDING. A SECOND IMPLANTATION ATTEMPT WAS MADE WITH THE SAME VALVE, BUT THE PROSTHESIS AGAIN APPEARED SIGNIFICANTLY UNDER-EXPANDED, LEADING TO REMOVAL OF THE DEVICE. A NEW VALVE WAS LOADED, AND FLUOROSCOPY CONFIRMED CORRECT LOADING. DURING THE FIRST IMPLANTATION ATTEMPT WITH THE NEW VALVE, THE PROSTHESIS AGAIN APPEARED UNDER-EXPANDED, THOUGH WITHOUT INFOLDING. THE VALVE WAS THEN RELEASED, POST-DILATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A 20-MINUTE PROCEDURE DELAY OCCURRED IN RESULT OF THE INFOLD AND EXPANSION ISSUES. ADDITIONALLY, THE PATIENT HAD SEVERE CALCIFICATION THAT CONTRIBUTED TO THE INFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273615 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-34

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male