BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 23337667 · Received October 20, 2025

    Report

    Report Number
    9617601-2025-02102
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 25, 2025
    Report Date
    March 23, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000716134
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID {D-EVOLUTFX-2329}; PRODUCT LOT/SERIAL NUMBER {UNKNOWN}; PRODUCT TYPE: {0195-HEARTVALVES}; 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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RECEIVED INSIDE A HEART VALVE RETURN KIT, FULLY SUBMERGED IN CLEAR 0.2% GLUTARALDEHYDE SOLUTION. LEAFLETS 1 AND 2 WERE OBSERVED IN THE CLOSED POSITION, WHILE LEAFLET 3 APPEARED PARTIALLY OPEN. ALL LEAFLETS DEMONSTRATED ADEQUATE FLEXIBILITY DURING MANIPULATION. LEAFLET 1 (L1): THROMBOTIC-APPEARING HOST GROWTH LINED THE MARGIN OF ATTACHMENT (MOA), EXTENDING TO BOTH SUPERIOR COAPTIVE JUNCTIONS (SCJS) WITH VISIBLE ADJACENT CREASES ALONG THE AFFECTED REGIONS. LEAFLET 1 DEMONSTRATED GOOD FLEXIBILITY. LEAFLET 2 (L2): THROMBOTIC-APPEARING HOST GROWTH LINED THE MOA, EXTENDING INTO THE CENTRAL REGION OF THE LEAFLET AND ONTO BOTH SCJS. A VERTICAL CREASE WAS PRESENT NEAR THE MOA DISTAL TO COMMISSURE 1-2. A LARGER VERTICAL CREASE WAS OBSERVED WITHIN THE MORE SUBSTANTIAL ADHERENT THROMBOTIC HOST GROWTH AT THE SJC OF COMMISSURE 2-3. THE DISTRIBUTION AND ADHERENCE OF THIS HOST GROWTH APPEARED TO INFLUENCE THE LEAFLET 2¿S MOBILITY. LEAFLET 3 (L3): THROMBOTIC-APPEARING HOST GROWTH LINED THE MOA, WITH A VISIBLE CREASE EXTENDING ALONG THE MOA. LEAFLET 3 DEMONSTRATED GOOD FLEXIBILITY. COMMISSURE 3-1 AND 1-2 APPEARED INTACT. COMMISSURE 2-3 DISPLAYED DISTAL ADHERENT THROMBOTIC-APPEARING HOST GROWTH ON LEAFLET 2; HOWEVER, THE COMMISSURE ITSELF APPEARED INTACT. VISUAL INSPECTION REVEALED NO DAMAGE TO THE SUTURES. THE FRAME APPEARED SLIGHTLY COMPRESSED AT THE INFLOW. NO STRUCTURAL DAMAGE, SUCH AS BENDS, KINKS OR FRACTURES, WAS OBSERVED. FURTHER REMNANTS OF THROMBOTIC-APPEARING HOST GROWTH WERE PRESENT ALONG THE OUTER LUMEN OF THE DEVICE. RADIOGRAPHIC IMAGES REVEALED NO EVIDENCE OF CALCIFICATION OR STENT FRACTURES ON THE RETURNED VALVE. 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

    ADDITIONAL INFORMATION: B5 (SECOND PARAGRAPH). 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 ONE DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT PRESENTED WITH AN ELEVATED GRADIENT AND HEMODYNAMIC INSTABILITY. A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED THE TRANSCATHETER VALVE MIGRATED INTO THE SINUS OF VALSALVA (SOV). SUBSEQUENTLY, THE TRANSCATHETER VALVE WAS EXPLANTED. THE PHYSICIAN NOTED THAT THE VALVE DID NOT DISLODGE DURING THE IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE DAY FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE PATIENT PRESENTED WITH AN ELEVATED GRADIENT AND HEMODYNAMIC INSTABILITY. A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED THE TRANSCATHETER VALVE MIGRATED INTO THE SINUS OF VALSALVA (SOV). SUBSEQUENTLY, THE TRANSCATHETER VALVE WAS EXPLANTED. THE PHYSICIAN NOTED THAT THE VALVE DID NOT DISLODGE DURING THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VALVE WAS IMPLANTED IN THE PATIENT'S NATIVE ANNULUS. THE VALVE IMPLANT DEPTH WAS 5 MM ON THE NON-CORONARY CUSP (NCC) AND 3 MM ON THE LEFT CORONARY CUSP (LCC). THE MEAN GRADIENT BEFORE THE VALVE WAS IMPLANTED WAS 35 MMHG AND WAS 5 MMHG AFTER VALVE IMPLANT. ACCORDING TO THE REPORTER, THERE WERE NO OBVIOUS PATIENT ANATOMICAL FACTORS THAT CONTRIBUTED TO THE ELEVATED GRADIENT OR VALVE MIGRATION. IT WAS ALSO STATED THAT THERE WAS NO EVIDENCE OF THROMBUS OR LEAFLET THICKENING ON THE TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285869 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-26 00763000716134

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Life Threatening| R| H SEE H11...