BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22994409 · Received September 8, 2025

    Report

    Report Number
    9612164-2025-04430
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 9, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-26 (K945270); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A. 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

    UPDATED: B5, H6, H8. 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, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION USING A 20 MILLIMETER (MM) BALLOON. THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED 3 TIMES AT AN IMPLANT DEPTH OF 3 MM; HOWEVER, UNDER EXPANSION OF THE VALVE FRAME WAS OBSERVED AND THE VALVE DISLODGED VENTRICULAR DURING EACH DEPLOYMENT ATTEMPT. THEREFORE, THE VALVE WAS RECAPTURED FOLLOWING EACH DEPLOYMENT ATTEMPT. UPON VALVE INSPECTION, THERE WERE NO ABNORMALITIES OR INFOLD. SUBSEQUENTLY, A NEW TRANSCATHETER VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS). ANOTHER PRE-IMPLANT BAV WAS PERFORMED USING A 23 MM BALLOON, AND THE NEW VALVE WAS SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE DEPTH OF IMPLANT WAS A CONTRIBUTING FACTOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO CALCIFICATION USING A 20 MILLIMETER (MM) BALLOON. THE DEPLOYMENT OF THE VALVE WAS ATTEMPTED 3 TIMES AT AN IMPLANT DEPTH OF 3 MM; HOWEVER, UNDER EXPANSION OF THE VALVE FRAME WAS OBSERVED AND THE VALVE DISLODGED VENTRICULAR DURING EACH DEPLOYMENT ATTEMPT. THEREFORE, THE VALVE WAS RECAPTURED FOLLOWING EACH DEPLOYMENT ATTEMPT. UPON VALVE INSPECTION, THERE WERE NO ABNORMALITIES OR INFOLD. SUBSEQUENTLY, A NEW TRANSCATHETER VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM (DCS). ANOTHER PRE-IMPLANT BAV WAS PERFORMED USING A 23 MM BALLOON, AND THE NEW VALVE WAS SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE DEPTH OF IMPLANT WAS A CONTRIBUTING FACTOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT 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 APPROXIMATELY 3 MM ON THE NCC. AFTER THE DISLODGEMENT, THE VALVE WAS SLIGHTLY ABOVE THE ANNULUS. THE PATIENT'S CALCIFIED ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055650 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012827591 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female SEE H11.