BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 24081359 · Received January 15, 2026

    Report

    Report Number
    9617601-2026-00302
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000920449
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-34 (LOT: 0013146655); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE DEVICE PRODUCT ID L-EVOLUTFX-34 (LOT: 0012992700); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE DEVICE PRODUCT ID EVFXPLUS-34 (R040155); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2026 PRODUCT ID: 25 MM SEMI-COMPLIANT BALLOON (NON-MEDTRONIC DEVICE); LOT #: UNKNOWN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE TRANSCATHETER AORTIC VALVE EVFXPLUS-34, A POST-IMPLANT BALLOON DILATION WITH A 25 MM SEMI-COMPLIANT BALLOON WAS PERFORMED DUE TO UNDEREXPANSION OF THE VALVE. DURING POST-DILATION, WITH PACING PERFORMED UNDER THE GUIDEWIRE, THE CLAMP CAME OFF WHILE THE BALLOON WAS NOT FULLY DEFLATED, CAUSING THE VALVE TO DISLODGE. THE PATIENT EXPERIENCED CARDIAC ARREST, AND CARDIAC MASSAGE WAS IMMEDIATELY PERFORMED. A SECOND VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS SUBSEQUENTLY HEMODYNAMICALLY UNSTABLE, REQUIRING PLACEMENT OF A TEMPORARY PACEMAKER AND INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145937 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-34 00763000920449

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| L SEE H11...