BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 23818185 · Received December 16, 2025

    Report

    Report Number
    9612164-2025-06229
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 15, 2025
    Report Date
    January 15, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000942700
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: THIRTY-NINE MEDIA IMAGES OF THE EVENT WERE PROVIDED. THERE WAS NO EXECUTIVE SUMMARY OR COMPUTED TOMOGRAPHY (CT) IMAGES PROVIDED FOR ANATOMICAL CONSIDERATION. THERE WAS A FLUOROSCOPY VALVE CHECK PROVIDED AND THE VALVE APPEARS TO BE LOADED CORRECTLY. IT WAS REPORTED THAT UPON FULL DEPLOYMENT OF A TRANSCATHETER VALVE, ONE OF THE PADDLES OF THE VALVE DID NOT RELEASE FROM THE DELIVERY CATHETER SYSTEM (DCS). THERE WAS NO EVIDENCE OF THE VALVE BEING RELEASED THEREFORE THERE CAN BE NO COMMENT ON WHAT WAS REPORTED. THERE IS EVIDENCE OF THE VALVE AT THE POINT OF NO RECAPTURE AT A DEPTH THAT IS >1 AND 5MM IN THE LAO PROJECTION. EVIDENCE SHOWS THE VALVE WAS THEN SNARED AND PULLED INTO THE ASCENDING AORTA WITH THE SNARE. EVIDENCE THEN SHOWS A SECOND VALVE BEING PLANTED WITH THE SNARE REMOVED FROM THE PADDLE OF THE FIRST VALVE. PER MEDTRONIC BEST PRACTICES WE SHOULD KEEP THE SNARE ATTACHED TO THE FIRST VALVE SO THAT IT DOES NOT DESCEND IN THE ASCENDING AORTA WITH PLACEMENT OF THE SECOND VALVE. THERE WAS NO EVIDENCE OF A FLUOROSCOPY VALVE CHECK PROVIDED FOR THE SECOND VALVE. THE VALVE WAS THEN IMPLANTED IN AN LAO PROJECTION AND APPEARS TO BE >5MM ON THE LEFT CORONARY CUSP (LCC) IN THE LAO PROJECTION. PER THE INSTRUCTIONS FOR USE (IFU) WE SHOULD CONSIDER A RECAPTURE IF THE VALVE IS >5MM TO AVOID RISK OF VENTRICULAR DISLODGEMENT, CONDUCTION DISTURBANCE, OR PARAVALVULAR LEAK (PVL). IT WAS REPORTED THAT THE SECOND VALVE WAS IMPLANTED AT A POSITION THAT WAS NOT FAVORABLE TO THE PATIENT AS AORTIC REGURGITATION OF UNSPECIFIED SEVERITY WAS OBSERVED. EVIDENCE SHOWS THE PATIENT APPEARS TO ANGIOGRAPHICALLY HAVE MORE THAN MILD REGURGITATION. TO COMMENT ON THE SEVERITY OF REGURGITATION AN ECHOCARDIOGRAM OR HEMODYNAMICS WOULD BE NEEDED TO CONFIRM. PER MEDTRONIC BEST PRACTICES TO ADDRESS SIGNIFICANT PVL, CONSIDER A POST DILATATION TO THE APPROPRIATE SIZE OF THE PATIENTS ANATOMY. A THIRD VALVE WAS THEN IMPLANTED AND DEPLOYED AT APPROXIMATELY ONE DIAMOND ABOVE THE PREVIOUS VALVE. THERE WAS NO EVIDENCE OF A VALVE CHECK FOR THE THIRD VALVE. IT WAS REPORTED THAT A NON-MEDTRONIC SUPER ST IFF GUIDE WIRE WAS USED. IT WAS REPORTED THAT UPON FINAL FLUOROSCOPIC INSPECTION, A DISSECTION ALONG THE DESCENDING AORTA WAS OBSERVED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE DESCENDING AORTIC DISSECTION. EVIDENCE SHOWS THE DISSECTION IS STILL POSSIBLY PRES ENT AFTER THE STENT WAS PLACED. 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 H10: 9617601-2025-03509, 9617601-2025-03511, 9612164-2025-06228, 9612164-2025-06230. UPDATED: B1, B5, H6, H10, H8, H11. 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

    SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. CONTINUATION OF D10: PRODUCT ID EVFXPLUS-29 ((B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; 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

    IT WAS REPORTED THAT UPON FULL DEPLOYMENT OF A TRANSCATHETER VALVE, ONE OF THE PADDLES OF THE VALVE DID NOT RELEASE FROM THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS PUSHED AND PULLED, AND THE VALVE WAS RELEASED; HOWEVER, THE VALVE DISLODGED TO THE ASCENDING AORTA. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED. IT WAS REPORTED THAT THE SECOND VALVE WAS IMPLANTED AT A POSITION THAT WAS NOT FAVORABLE TO THE PATIENT AS AORTIC REGURGITATION OF UNSPECIFIED SEVERITY WAS OBSERVED. SUBSEQUENTLY, A THIRD VALVE WAS IMPLANTED PROPERLY AT AN OPTIMAL POSITION WITH GOOD HEMODYNAMICS. UPON FINAL FLUOROSCOPIC INSPECTION, A DISSECTION ALONG THE DESCENDING AORTA WAS OBSERVED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE DESCENDING AORTIC DISSECTION. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU). PER THE PHYSICIAN, IT WAS SUSPECTED THAT THE FIRST DCS CONTRIBUTED TO THE AORTIC DISSECTION. ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS NOT PERFORMED AND A NON-MEDTRONIC (AMPLATZ SUPER STIFF) 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 5-6 MM ON THE NON-CORONARY CUSP (NCC) AND 6 MM ON THE LEFT CORONARY CUSP (LCC). AFTER THE VALVE DISLODGEMENT, THE IMPLANT DEPTH WAS APPROXIMATELY -5 MM IN EACH CUSP. THE SECOND VALVE WAS IMPLANTED TOO DEEP (10-12 MM IN LAO VIEW) WITH SEVERE PARAVALVULAR LEAK (PVL) NOTED. IT WAS REPORTED TO BE UNKNOWN WHEN THE DISSECTION OCCURRED BUT WAS NOTICED AFTER THE THIRD VALVE IMPLANTATION. THE DISSECTION WAS CONSIDERED LIKELY TO OCCUR BETWEEN THE FIRST AND SECOND VALVE, SPECIFICALLY WHEN SNARING THE FIRST VALVE AND ADVANCING THE SECOND DCS PER THE PHYSICIAN. THE PHYSICIAN ATTRIBUTED THE DISSECTION TO THE SECOND DCS BUT NOT THE FIRST OR THIRD DCS, OR THE NON-MEDTRONIC GUIDEWIRE. THE PATIENT ANATOMY HAD CURVATURE AND CALCIFICATION AT THE AORTIC ARCH WHICH WERE CONTRIBUTING FACTORS TO THE DISSECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON FULL DEPLOYMENT OF A TRANSCATHETER VALVE, ONE OF THE PADDLES OF THE VALVE DID NOT RELEASE FROM THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS PUSHED AND PULLED, AND THE VALVE WAS RELEASED; HOWEVER, THE VALVE DISLODGED TO THE ASCENDING AORTA. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED. IT WAS REPORTED THAT THE SECOND VALVE WAS IMPLANTED AT A POSITION THAT WAS NOT FAVORABLE TO THE PATIENT AS AORTIC REGURGITATION OF UNSPECIFIED SEVERITY WAS OBSERVED. SUBSEQUENTLY, A THIRD VALVE WAS IMPLANTED PROPERLY AT AN OPTIMAL POSITION WITH GOOD HEMODYNAMICS. UPON FINAL FLUOROSCOPIC INSPECTION, A DISSECTION ALONG THE DESCENDING AORTA WAS OBSERVED. SUBSEQUENTLY, A STENT WAS PLACED TO TREAT THE DESCENDING AORTIC DISSECTION. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU). PER THE PHYSICIAN, IT WAS SUSPECTED THAT THE FIRST DCS CONTRIBUTED TO THE AORTIC DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445695 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012294209 00763000942700

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Male Required Intervention| L| H SEE H11.