BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22647589 · Received July 29, 2025

    Report

    Report Number
    9612164-2025-03694
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000365721
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-34 (K040083); 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

    UPDATED DATA: B5 H2 H3 H6 IMAGE REVIEW: TWO IMAGES AND ONE MEDIA FILE WERE PROVIDED FOR REVIEW OF THE EVENT. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS NOT PROVIDED FOR REVIEW THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. IT WAS REPORTED THAT ONE RECAPTURE WAS PERFORMED DUE TO DISLODGMENT AND DURING THE SUBSEQUENT DEPLOYMENT ATTEMPT AN INFOLD OCCURRED. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE 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 DISCARDED. NEW STERILE COMPONENTS MUST BE USED. IT WAS REPORTED THAT THE INFOLDED VALVE WAS NOT IMPLANTED, AND A NEW SYSTEM WAS USED. 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: 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 TRANSCATHETER AORTIC VALVE PROCEDURE INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-34, THE VALVE WAS LOADED WITHOUT ANY ISSUES AND A FLUOROSCOPY CHECK SHOWED NO CROWN OVERLAP. DURING THE FIRST DEPLOYMENT, AN EXTRASYSTOLE OCCURRED AND THE VALVE DISLODGED. THE VALVE WAS RECAPTURED IN THE ASCENDING AORTA. DURING THE SECOND DEPLOYMENT, THE VALVE SHOWED INFOLDING.THE VALVE WAS THEN REPLACED BY A NEW VALVE, WHICH WAS IMPLANTED WITHOUT ANY ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE VALVE IMPLANT, A PRE IMPLANT BALLOON DILATION WAS PERFORMED WITH A 22 MILLIMETER (MM) BALLOON. DURING THE VALVE IMPLANT, THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF PIGTAIL AT AN IMPLANT DEPTH OF APPROXIMATELY 4 MILLIMETER (MM) ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). AFTER THE VALVE DISLODGED AORTIC, THE IMPLANT DEPTH WAS APPROXIMATELY 4 MM ON THE NCC AND LCC. A NON-MEDTRONIC GUIDEWIRE (SAFARI) WAS USED. THE VALVE WAS RECAPTURED IN THE ASCENDING AORTA. AN APPROXIMATE PROCEDURAL DELAY OF 10 MIN RESULTED AS A NEW VALVE WAS LOADED. PER THE PHYSICIAN, THERE WAS NO PATIENT ANATOMICAL FEATURES THAT CONTRIBUTED TO THE INFOLDING OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887142 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-34 0012637275 00763000365721

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male SEE H11...