BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 24402443 · Received February 20, 2026

    Report

    Report Number
    9612164-2026-00948
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000822132
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. CONTINUATION OF D10: PRODUCT ID: L-EVOLUTFX-2329 (LOT: 0012967666); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID: EVFXPLUS-29 (R063587); 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. 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 PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A SMALLER NON-MEDTRONIC BALLOON WAS USED TO PERFORM A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO SEVERE CALCIFICATION AND THE RISK OF AN ANNULAR RUPTURE. DURING LOADING, A NODE OVERLAP EXTENDING TO BEFORE THE FOURTH NODE WAS NOTED. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED UPWARDS AND WAS RECAPTURED. UPON THE SECOND DEPLOYMENT ATTEMPT, THE "C-ARM" WAS ROTATED TO CHECK FOR THE EXPANSION OF THE VALVE, AND AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A SECOND VALVE WAS LOADED. ANOTHER PRE-IMPLANT BAV WAS PERFORMED, AND THE NEW VALVE WAS SUCCESSFULLY DEPLOYED. IT WAS SUSPECTED THAT THE PATIENT'S CALCIFICATION CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF A TRANSCATHETER VALVE, A SMALLER NON-MEDTRONIC BALLOON WAS USED TO PERFORM A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) DUE TO SEVERE CALCIFICATION AND THE RISK OF AN ANNULAR RUPTURE. DURING LOADING, A NODE OVERLAP EXTENDING TO BEFORE THE FOURTH NODE WAS NOTED. UPON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED UPWARDS AND WAS RECAPTURED. UPON THE SECOND DEPLOYMENT ATTEMPT, THE "C-ARM" WAS ROTATED TO CHECK FOR THE EXPANSION OF THE VALVE, AND AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A SECOND VALVE WAS LOADED. ANOTHER PRE-IMPLANT BAV WAS PERFORMED, AND THE NEW VALVE WAS SUCCESSFULLY DEPLOYED. IT WAS SUSPECTED THAT THE PATIENT'S CALCIFICATION CONTRIBUTED TO THE EVENT. NO PATIENTCOMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT TWO DIFFERENT MEDTRONIC GUIDEWIRES WERE USED DURING THE IMPLANT PROCEDURE. THE DEPLOYMENT S TARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. PRIOR TO VALVE DISLODGEMENT, THE IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) WAS 3 MILLIMETERS (MM), AND THE IMPLANT DEPTH ON THE LEFT CORONARY CUSP (LCC) WAS 3 MM. AFTER VALVE DISLODGEMENT, THE IMPLANT DEPTH ON THE NCC WAS 2 MM, AND THE IMPLANT DEPTH ON THE LCC WAS 4 MM. IT WAS NOTED THAT A PROCEDURAL DELAY OCCURRED BECAUSE A SECOND VALVE WAS PREPARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463216 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012988828 00763000822132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown