BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 22310011 · Received June 23, 2025

    Report

    Report Number
    2025587-2025-04410
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 13, 2025
    Report Date
    September 18, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000920418
    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, (LOT: 0012790368); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: EVFXPLUS-23, (K080922); PRODUCT TYPE: 0195-HEART VALVES; 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

    PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS RETURNED LOADED INSIDE THE DELIVERY SYSTEM. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE WAS RECEIVED IN A COMPRESSED STATE. ALL LEAFLETS EXHIBITED SIGNS OF DESICCATION, CREASES, AND FRAME IMPRINTS. THESE CONDITIONS MAY BE ASSOCIATED WITH THE VALVE BEING CRIMPED INSIDE THE CAPSULE OF THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION. THE LEAFLETS WERE STIFF YET SLIGHTLY FLEXIBLE. AS RECEIVED, ALL LEAFLETS APPEARED OPEN. ALL COMMISSURES APPEARED INTACT. BENT STRUTS WERE OBSERVED ON THE INFLOW CROWN AND NODE 2 BELOW COMMISSURE 1-2. REMNANTS OF COAGULATED BLOOD WERE OBSERVED THROUGHOUT THE VALVE. TWO HOLES WERE FOUND ON THE VALVE SKIRT BELOW LEAFLET 3. UPDATED H.6. 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: B5. H6. ADDITIONAL CODES. 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 THE IMPLANTATION OF THE TRANSCATHETER AORTIC VALVE, THE VALVE WAS SUCCESSFULLY LOADED. DURING THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS POSITIONED TOO LOW. THE VALVE WAS THEN RECAPTURED. A SECOND DEPLOYMENT ATTEMPT WAS MADE HOWEVER AT 2/3 DEPLOYMENT, AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW VALVE WAS THEN SUCCESSFULLY LOADED. DURING THE FIRST DEPLOYMENT ATTEMPT, AN INFOLD WAS NOTED AT 2/3 DEPLOYMENT. THE VALVE WAS RECAPTURED AND REMOVED. A THIRD VALVE WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A PROCEDURAL DELAY OF APPROXIMATELY 10 MINUTES OCCURRED. PER THE PHYSICIAN, THE PATIENT'S ANNULAR CALCIFICATION CONTRIBUTED TO THE INFOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219082 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-23 00763000920418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11