BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 23512494 · Received November 10, 2025

    Report

    Report Number
    9612164-2025-05529
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000589707
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012690246); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTFX-23 (K002928); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, ISSUES WITH CEREBRAL PERFUSION OCCURRED DURING LEFT CAROTID CUT-DOWN, NECESSITATING THE PLACEMENT OF A SHUNT FROM THE LEFT FEMORAL ARTERY TO THE LEFT CAROTID ARTERY TO MAINTAIN ADEQUATE CEREBRAL PERFUSION. MULTIPLE UNSUCCESSFUL DEPLOYMENT ATTEMPTS WERE MADE, WITH THE FIRST THREE ATTEMPTS RESULTING IN POSITIONING THAT WAS TOO DEEP. ON THE FOURTH ATTEMPT, DEPLOYMENT WAS ACHIEVED WITH MEASUREMENTS OF 5 MILLIMETERS AT THE NON-CORONARY CUSP AND 7 MILLIMETERS AT THE LEFT CORONARY CUSP. COMMISSURAL ALIGNMENT WAS NOT PRIORITIZED OR ACHIEVED. A GRADIENT MEASUREMENT OF 12 MMHG WAS REPORTED WITH GOOD PERFUSION TO THE PRE-EXISTING LEFT CORONARY ARTERY STENT. ONE PADDLE (NON-C TAB) BECAME HUNG UP ON FINAL RELEASE AND WAS FREED BY RECAPTURING THE CAPSULE. THE PATIENT WAS FOUND TO BE IN ATRIAL FIBRILLATION AT THE END OF THE CASE AND WAS SUCCESSFULLY CARDIOVERTED INTO SINUS RHYTHM ON THE SECOND ATTEMPT. THE PATIENT HAD A HIGH STS SCORE OF 29%, INDICATING ELEVATED SURGICAL RISK. CONTRIBUTING FACTORS TO THE MULTIPLE RECAPTURES INCLUDED ROOM SETUP FOR CAROTID ACCESS, DIFFICULTIES VISUALIZING THE SCREEN TO ADJUST DEPTH, LIMITED CONTROL OF THE WORKING WIRE, AND VALVE SELECTION CONSIDERATIONS DUE TO PATIENT ANATOMY AND STENT POSITION. THE PATIENT'S MEASUREMENTS WERE BORDERLINE BETWEEN A 23 AND 26 MM VALVE, HOWEVER GIVEN THE SMALL BODY HABITUS OF THE PATENT, CALCIUM BURDEN, PROTRUDING LEFT CORONARY ARTERY STENT AND 10% OVER-SIZING, THE 23 MM VALVE WAS CHOSEN FOR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582335 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012642929 00763000589707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown