BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 21833692 · Received April 14, 2025

    Report

    Report Number
    2025587-2025-02627
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 9, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012294207); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE (B)(6) 2025 PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012416833); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID EVFXPLUS-29 (K032261); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE 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 DATA: E1. CORRECTED DATA: 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 DURING AN INITIAL IMPLANT PROCEDURE INVOLVING A TRANSCATHETER AORTIC VALVE, UPON INITIAL DEPLOYMENT TO A DEPTH OF 3 MM TO 5 MM, THE VALVE APPEARED UNDER-EXPANDED. WHEN THE C-ARM ANGLE WAS ADJUSTED, IT WAS NOTED THAT THE INFLOW APPEARED ELLIPTICAL IN SHAPE. THE UNDER-EXPANSION WAS ATTRIBUTED TO CALCIFIED ANATOMY. THE FIRST VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A SECOND VALVE WAS LOADED INTO A SECOND DELIVERY CATHETER SYSTEM AND CHECKED VIA FLUOROSCOPY. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 23 MM NON-MEDTRONIC BALLOON. DESPITE ADJUSTMENTS, UPON DEPLOYMENT TO 80%, THE SAME ELLIPTICAL INFLOW AND UNDER-EXPANSION ISSUES WERE NOTED. THE SECOND VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A SECOND BAV WAS PERFORMED USING A 26 MM NON-MEDTRONIC BALLOON AND A THIRD VALVE WAS SUCCESSFULLY DEPLOYED AT A DEPTH OF APPROXIMATELY 3 MM ON THE NON-CO RONARY CUSP AND 3 MM ON THE LEFT CORONARY CUSP. AN INVASIVE HEMODYNAMICS CHECK REVEALED A GRADIENT OF 4 MM HG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080641 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-29

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male