BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 21815828 · Received April 10, 2025

    Report

    Report Number
    2025587-2025-02542
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 13, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. D4. H4. 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: EVFXPLUS-26 (K041840); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE IN A PATIENT WITH A HIGH JET VELOCITY AND A VERY HIGH GRADIENT, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING AN 18 MM NON-MEDTRONIC BALLOON DUE TO A HEAVILY CALCIFIED ANNULUS. DURING THE FIRST DEPLOYMENT ATTEMPT TO 80%, THE VALVE MOVED TOO SHALLOW. THE VALVE WAS RECAPTURED AND REPOSITIONED. AFTER FULL DEPLOYMENT AT A DEPTH OF 3 MM ON THE NON-CORONARY CUSP AND 3 MM ON THE LEFT CORONARY CUSP, THE VALVE DISLODGED AORTIC. THE VALVE REMAINED IN PLACE FUNCTIONING AT A NEW DEPTH OF 0 MM AND 1 MM. AN ECHOCARDIOGRAM REVEALED MODERATE AORTIC INSUFFICIENCY AND UNDER-EXPANSION OF THE VALVE INFLOW. A POST-IMPLANT BAV WAS PERFORMED USING A 22 MM NON-MEDTRONIC BALLOON TO ADDRESS THE UNDER-EXPANDED VALVE. THE BALLOON SUCCESSFULLY EXPANDED THE VALVE'S INFLOW; HOWEVER, THE BALLOON CAUGHT ON THE BOTTOM OF THE VALVE FRAME. THE BALLOON CAUSED THE VALVE TO DISLODGE IN THE AORTIC DIRECTION AND THE VALVE MOVED INTO TO THE SINUS. THE PATIENT WAS STABLE, AND A SURGICAL AORTIC VALVE REPLACEMENT WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455040 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012610943

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female