BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 21505462 · Received March 3, 2025

    Report

    Report Number
    2025587-2025-01583
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000716141
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-29 (K002776); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID {D-EVOLUTFX-2329}; PRODUCT LOT/SERIAL NUMBER {UNKNOWN}; PRODUCT TYPE: {0195-HEART VALVES}; IMPLANT DATE {N/A}; EXPLANT DATE {N/A} PRODUCT ID {L-EVOLUTFX-2329}; PRODUCT LOT/SERIAL NUMBER {UNKNOWN}; 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROCEDURE INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED USING A 22 MM NON-MEDTRONIC BALLOON DUE TO CALCIFICATION. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT, ADVANCED TO THE ANNULUS, AND POSITIONED TO ALIGN THE HAT MARKER WITH THE BOTTOM OF THE PIG TAIL CATHETER WHICH WAS CENTERED ON THE NON-CORONARY CUSP (NCC). THE VALVE WAS INITIALLY DEPLOYED TO 80%. THE VALVE DEPTH AT 80% WAS APPROXIMATELY 4 MM BELOW THE ANNULAR PLANE ON THE NCC AND APPROXIMATELY 5 MM ON THE LEFT CORONARY CUSP (LCC). UNDER-EXPANSION OF THE VALVE FRAME AT THE INFLOW AND WAIST WAS OBSERVED. THIS WAS CONFIRMED ON MULTIPLE VIEWS WHICH WERE PERFORMED TO RULE OUT INFOLDING. THE VALVE WAS RECAPTURED AND REDEPLOYED AT THE SAME DEPTH AS THE FIRST ATTEMPT. THE SAME VISUAL APPEARANCE AS THE FIRST DEPLOYMENT WAS NOTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS CONDUCTED TO ASSESS VALVE FUNCTION. AN ECHOCARDIOGRAM REVEALED NO INFOLDING AND AN ACCEPTABLE GRADIENT. THE VALVE WAS FULLY RECAPTURED A SECOND TIME DUE TO THE CONTINUED EXPANSION ISSUE. THE VALVE AND DCS WERE WITHDRAWN FROM THE PATIENT. A REPLACEMENT VALVE WAS INSERTED INTO THE PATIENT AND DEPLOYED TO A DEPTH OF 4 MM ON THE NCC AND 5 MM ON THE LCC. UNDER-EXPANSION WAS AGAIN NOTED, BUT TO A LESSER DEGREE. PER THE PHYSICIAN, THE EXPANSION ISSUE WAS ANATOMICAL IN NATURE. A POST-DEPLOYMENT BALLOON VALVULOPLASTY WAS PERFORMED TO FULLY EXPAND THE VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677164 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-29 00763000716141

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male SEE H11...