BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 22285660 · Received June 18, 2025

    Report

    Report Number
    2025587-2025-04310
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 12, 2025
    Report Date
    September 15, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000920432
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: D-EVOLUTFX-2329; PRODUCT LOT NUMBER (UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE DEVICE PRODUCT ID L-EVOLUTFX-2329; PRODUCT LOT NUMBER (UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE DEVICE PRODUCT ID: EVFXPLUS-29 (K074779); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE; N/A; PRODUCT ID: EVFXPLUS-29 (K086096); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE; (B)(6) 2025; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: FOUR MEDIA FILES WERE PROVIDED FOR REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED AND CONFIRMED A GOOD LOAD. IT WAS REPORTED THAT A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT ATTEMPT, AND DURING THE VALVE DEPLOYMENT ATTEMPT, AN INFOLD WAS NOTED. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED AND REMOVED FROM THE BODY. NEW STERILE COMPONENTS MUST BE USED. THERE IS EVIDENCE THAT A NEW VALVE WAS LOADED AND CONFIRMED A GOOD LOAD. THE NEW VALVE WAS DEPLOYED JUST PRIOR TO THE POINT OF NO RECAPTURE, AND ANOTHER INFOLD OCCURRED. IT WAS REPORTED THAT A THIRD VALVE WAS LOADED AND IMPLANTED SUCCESSFULLY. IMAGES OF THE THIRD VALVE LOAD INSPECTION AND IMPLANTED VALVE WERE NOT PROVIDED. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. HOWEVER, IT IS KNOWN THAT THE PATIENT HAD HEAVILY CALCIFIED ANATOMY. UPDATED DATA: 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

    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 IN A PATIENT WITH HEAVILY CALCIFIED ANATOMY, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH A 20MM NON-MEDTRONIC BALLOON. FLUOROSCOPIC INSPECTION OF THE VALVE LOAD WAS CONDUCTED AND APPEARED SATISFACTORY. UPON THE INITIAL DEPLOYMENT ATTEMPT TO THE POINT OF NO RECAPTURE, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED AND ATTEMPTED DEPLOYMENT, BUT ANOTHER INFOLD WAS OBSERVED, LEADING TO RECAPTURE AND WITHDRAWAL OF THE SECOND VALVE. A BALLOON AORTIC VALVULOPLASTY WAS THEN PERFORMED WITH A 22MM NON-MEDTRONIC BALLOON. A THIRD VALVE WAS LOADED AND DEPLOYED SUCCESSFULLY. THE PROCEDURE DURATION WAS PROLONGED BY 30-40 MINUTES DUE TO REPEATED VALVE LOADINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767701 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-29 00763000920432

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female SEE H11...