BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 23236188 · Received October 7, 2025

    Report

    Report Number
    9617601-2025-01860
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0012779398); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVOLUTFX-34 (LOT: 0012812287); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-34 (LOT: 0012926717); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVOLUTFX-34 (LOT: 0012812287); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-34 (K094248); 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. 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: 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

    UPDATED DATA: B5. 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 A PATIENT WITH SEVERE CUSP CALCIFICATION ON TRI-LEAFLET ANATOMY AND SIGNIFICANT LANDING ZONE CALCIUM IN THE ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION. PRE-DILATATION WAS PERFORMED WITH A 22MM NON-COMPLIANT BALLOON. THE VALVE WAS DEPLOYED TO 80% IN A HIGH POSITION AND WAS SEVERELY CONSTRAINED, RESULTING IN THE PATIENT'S BLOOD PRESSURE NOT RECOVERING. METARAMINOL AND PHENYLEPHRINE WERE ADMINISTERED TO INCREASE BLOOD PRESSURE, BUT THESE INTERVENTIONS WERE INEFFECTIVE, AND THE PATIENT LOST CONSCIOUSNESS. THE VALVE WAS RECAPTURED TO ALLOW FLOW OUT OF THE HEART, LEADING TO PARTIAL PRESSURE RECOVERY AND THE PATIENT REGAINING CONSCIOUSNESS. A SECOND DEPLOYMENT ATTEMPT ALSO RESULTED IN SEVERE CONSTRAINT AND POSSIBLE INFOLD, WITH THE PATIENT EXPERIENCING ANOTHER HEMODYNAMIC COLLAPSE. THE VALVE WAS FULLY RELEASED, MOVED UP ON RELEASE, AND LANDED ABOVE THE ANNULUS AT APPROXIMATELY 3 MM ABOVE THE ANNULUS ON THE NON-CORONARY CUSP (NCC) SIDE AND 1-2 MM ON THE LEFT CORONARY CUSP (LCC) SIDE. THE VALVE REMAINED FIXED BUT NOT FULLY EMBOLISED AT THAT POINT. PRESSURE RECOVERED SLIGHTLY, BUT THE INFLOW REMAINED VERY CONSTRAINED. BEFORE POST-DILATATION COULD BE PERFORMED, THE VALVE FULLY EMBOLIZED TOWARDS THE SINOTUBULAR JUNCTION, AND PATIENT PRESSURES FULLY RECOVERED. THE EMBOLIZED VALVE DID NOT OBSTRUCT THE CORONARIES. THE VALVE WAS TOO LOW TO DEPLOY A SECOND VALVE, SO A GOOSE NECK SNARE WAS USED TO REPOSITION THE EMBOLIZED VALVE ABOVE THE SINOTUBULAR JUNCTION. A SECOND VALVE WAS DEPLOYED WHILE SNARING THE FIRST VALVE TO PREVENT SLIPPAGE, INTENTIONALLY PLACED DEEP AT APPROXIMATELY 6-7MM. THE SECOND VALVE WAS NOTABLY CONSTRAINED, PROMPTING POST-DILATATION WITH A 24MM NON-COMPLIANT BALLOON, WHICH RESULTED IN BETTER EXPANSION AND COMPETENCE, THOUGH SOME MINOR CONSTRAINT REMAINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE PATIENT'S HIGHLY CALCIFIED ANATOMY CONTRIBUTED TO THE VALVE UNDER EXPANSION RESULTING IN THE LOW BLOOD PRESSURE AND NOT THE HIGH POSITIONING OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488552 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-34

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Required Intervention SEE H11...