BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 24767299 · Received April 2, 2026

    Report

    Report Number
    9612164-2026-01696
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000942700
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4. UDI # WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH. H6. ANNEX B CODE WAS ADDED TO REPLACE THE ANNEX B CODE SUBMITTED ON THE INITIAL MEDWATCH. ANNEX D CODE WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH. ADDITIONAL CODES. ANNEX F CODE WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH. 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 {EVFXPLUS-29}; PRODUCT LOT/SERIAL NUMBER {R023555}; 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE DISLODGED WHILE STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). SUBSEQUENTLY, THE VALVE WAS RECAPTURED. UPON THE SECOND DEPLOYMENT ATTEMPT, THE DCS WAS UNABLE TO ADVANCE THROUGH THE NATIVE ANNULUS. SUBSEQUENTLY, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT, AND A NEW VALVE AND DCS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249898 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0013293847 00763000942700

    Patients

    Seq Age Sex Outcome Treatment
    1