BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 23315967 · Received October 16, 2025

    Report

    Report Number
    9612164-2025-05115
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000822132
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-29 (K968297); 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.

    Additional Manufacturer Narrative · 0

    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 PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE IN A PREVIOUSLY IMPLANTED NON-MEDTRONIC HOMOGRAFT VALVE, THE PATIENT HAD A PRE-EXISTING MEAN GRADIENT OF 34 MILLIMETERS OF MERCURY (MM HG) AND AORTIC REGURGITATION. DURING VALVE LOADING CHECK, NO MISLOAD WAS IDENTIFIED. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED VENTRICULAR AND WAS SUBSEQUENTLY RECAPTURED ABOVE THE ANNULUS. UPON THE SECOND DEPLOYMENT ATTEMPT, AN INFOLD WAS OBSERVED ON FLUOROSCOPY. IT WAS NOTED THAT THE TARGET IMPLANT DEPTH WHEN THE INFOLD OCCURRED WAS 3 MILLIMETERS (MM). SUBSEQUENTLY, THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS), AND WAS SUCCESSFULLY IMPLANTED AFTER ONE RECAPTURE. PER THE PHYSICIAN, THE PATIENT'S CALCIFIED ANATOMY AND HOMOGRAFT CONTRIBUTED TO THE EVENT. IT WAS NOTED THAT A 5 MINUTE PROCEDURAL DELAY OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEPLOYMENT STARTING POINT FOR THE FIRST VALVE WAS IN THE MIDDLE OF THE PIGTAIL CATHETER. PRIOR TO VALVE DISLODGEMENT, THE IMPLANT DEPTH OF 3 MM WAS APPROACHED FROM ABOVE THE NON-CORONARY CUSP (NCC) DURING DEPLOYMENT TO 80%. AFTER DISLODGEMENT, THE VALVE DISLODGED VENTRICULAR TO AN APPROXIMATE IMPLANT DEPTH OF 5 MM. A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE SECOND VALVE WAS RECAPTURED DUE TO AN APPROXIMATE IMPLANT DEPTH OF 5 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665915 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012468075 00763000822132

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male SEE H11...