BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 25133193 · Received May 9, 2026

    Report

    Report Number
    9617601-2026-03027
    Event Type
    Malfunction
    Date Received
    May 9, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 9, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000370626
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID D-EVOLUTFX-2329 (LOT: 0013361796); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0013361796); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTFX-29 (R242108); PRODUCT TYPE: 0195-HEART VALVES. 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 AN EVOLUT FX TRANSCATHETER HEART VALVE IMPLANTATION WAS PERFORMED FOR AORTIC STENOSIS IN THE SETTING OF A HEAVILY CALCIFIED AORTIC VALVE, AND FRAME INFOLD WAS OBSERVED DURING THE FIRST VALVE DEPLOYMENT. A FLUOROSCOPIC CHECK NOTED NO MISLOAD, AND THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. PRE-DILATION WAS THEN PERFORMED WITH A BIGGER BALLOON PER PHYSICIAN DECISION, AFTER WHICH A SECOND VALVE WAS DEPLOYED AND FRAME INFOLD WAS AGAIN OBSERVED ON FIRST DEPLOYMENT; A FLUOROSCOPIC CHECK AGAIN NOTED NO MISLOAD, AND THE SECOND VALVE WAS REMOVED FROM THE PATIENT. A THIRD PRE-DILATION WAS PERFORMED WITH A NEW BALLOON PER PHYSICIAN DECISION, AND A THIRD VALVE WAS IMPLANTED WITH NO MISLOAD NOTED ON FLUOROSCOPIC CHECK, FOLLOWED BY POST-DILATION. THE FINAL RESULT WAS REPORTED AS EXCELLENT WITH ZERO GRADIENT AND NO PARAVALVULAR LEAK, WITH NO SIGNIFICANT PROCEDURAL DELAY, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460513 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-29 00763000370626

    Patients

    Seq Age Sex Outcome Treatment
    1