BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 23425422 · Received October 30, 2025

    Report

    Report Number
    9617601-2025-02411
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000920432
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: FOURTEEN MEDIA IMAGES WERE PROVIDED FOR REVIEW. THE EXECUTIVE SUMMARY IMAGES WERE ALSO PROVIDED FOR ANATOMICAL CONSIDE RATION. THE ANNULUS MEASURES 77.2 MM IN SYSTOLE, AND 74.5 MM IN DIASTOLE, WITH A LEFT VENTRICULAR OUTFLOW TRACT (LVOT) MEASUREMENT SLIGHTLY LARGER AT 78.4 MM. ALL THESE MEASUREMENTS ARE IN LINE WITH THE INSTRUCTIONS FOR USE (IFU) FOR A 29 MM VALVE. A FLUOROSCOPIC VALVE CHECK WAS NOT PROVIDED THEREFORE IT CANNOT BE CONFIRMED IF THE VALVE WAS LOADED PROPERLY AND NO EVIDENCE WAS PROVIDED OF THE PRE-IMPLANT BALLOON DILATION. EVIDENCE SHOWS THE START OF VALVE DEPLOYMENT AT APPROXIMATELY 4 MM ON THE NON-CORONARY CUSP (NCC) IN THE CUSP OVERLAP VIEW. THERE WAS NO IMAGE PROVIDED IN THE CUSP OVERLAP VIEW OF THE VALVE AT THE POINT OF NO RECAPTURE TO ACCURATELY ASSESS DEPTH. IN THE LAO PROJECTION THE VALVE IS APPROXIMATELY 4-5 MM ON THE LEFT CORONARY CUSP (LCC). THE NCC DEPTH CANNOT BE ACCURATELY ACCESSED IN THIS VIEW, HOWEVER, IT DOES APPEAR TO BE BELOW THE NCC. PER THE IFU, IF THE VALVE IS 1 OR >5 MM, CONSIDER A RECAPTURE DUE TO RISK OF VALVE MIGRATION. IN AN ATTEMPT TO REPOSITION THE VALVE TO A DEEPER DEPTH, THE VALVE WAS THEN IMPLANTED TO THE POINT OF NO RECAPTURE TO 15-20 MM ON THE LCC IN THE LAO PROJECTION. EVIDENCE SHOWS A THIRD DEPLOYMENT WITH THE VALVE IN THE LAO PROJECTION AT A DEPTH OF 6-7 MM ON THE LCC. THE NCC DEPTH CANNOT BE ASSESSED IN THE LAO PROJECTION. EVIDENCE SHOWS ON RELEASE THE VALVE MIGRATED TO APPROXIMATELY 15-20 MM ON THE LCC. AN ATTEMPT TO REPOSITION THE PROSTHESIS USING TWO SNARES RESULTED IN THE VALVE DISLODGING OUT. A SECOND VALVE WAS LOADED, BUT IT WAS NOT POSSIBLE TO PASS THE SECOND DELIVERY CATHETER SYSTEM (DCS) THROUGH THE FIRST VALVE. PER THE IFU, POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF THE BIOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, VALVE MIGRATION. DUE TO THESE PROCEDURAL COMPLICATIONS, THE IMPLANTER DECIDED TO USE A NON-MEDTRONIC VALVE. UPDATED: 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012912461); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012920046); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012912461); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-29 (SERIAL: R030093); 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: B5. 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 IMPLANTATION PROCEDURE, PRE-DILATATION OF THE NATIVE AORTIC VALVE WAS PERFORMED USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. UPON RELEASE, THE VALVE SLIPPED INTO THE VENTRICLE. AN ATTEMPT TO REPOSITION THE PROSTHESIS USING TWO SNARES RESULTED IN THE VALVE DISLODGING OUT. A SECOND VALVE WAS LOADED, BUT IT WAS NOT POSSIBLE TO PASS THE SECOND CATHETER THROUGH THE FIRST VALVE. DUE TO THESE PROCEDURAL COMPLICATIONS, THE IMPLANTER DECIDED TO USE A NON-MEDTRONIC VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, PRE-DILATATION OF THE NATIVE AORTIC VALVE WAS PERFORMED USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. UPON RELEASE, THE VALVE SLIPPED INTO THE VENTRICLE. AN ATTEMPT TO REPOSITION THE PROSTHESIS USING TWO SNARES RESULTED IN THE VALVE DISLODGING OUT. A SECOND VALVE WAS LOADED, BUT IT WAS NOT POSSIBLE TO PASS THE SECOND CATHETER THROUGH THE FIRST VALVE. DUE TO THESE PROCEDURAL COMPLICATIONS, THE IMPLANTER DECIDED TO USE A NON-MEDTRONIC VALVE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (SAFARI) GUIDEWIRE WAS USED FOR THE PROCEDURE. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. PRIOR TO VALVE DISLODGEMENT, THE IMPLANT DEPTH WAS 3 MM ON THE NON-CORONARY CUSP (NCC) AND 8 MM ON THE LEFT CORONARY CUSP (LCC). AFTER DISLODGEMENT, THE IMPLANT DEPTH WAS 15 MM ON THE NCC AND 20 MM ON THE LCC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409517 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-29 00763000920432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.