BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 24223619 · Received January 30, 2026

    Report

    Report Number
    9617601-2026-00808
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000920432
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RETURNED IN ITS ORIGINAL OUTER PACKAGING AND WITHIN ITS ORIGINAL PACKAGING JAR. THE JAR WAS RECEIVED WITH THE YELLOW SAFETY BROKEN, AND THE DEVICE FULL SUBMERGED IN SOLUTION. UPON OPENING THE JAR, AMBER-COLORED PARTICULATE MATTER WAS OBSERVED WITHIN THE SOLUTION. ADDITIONAL AMBER-COLORED PARTICULATES WERE NOTED ON THE INFLOW ASPECT OF THE VALVE. FOLLOWING REMOVAL OF THE VALVE FROM THE JAR, MULTIPLE, AMBER-COLORED PARTICULATES WERE OBSERVED ALONG THE OUTFLOW CROWN OF THE FRAME. BASED ON THE VISUAL APPEARANCE, THE OBSERVED PARTICULATES ARE CONSISTENT WITH MATERIAL TYPES THAT HAVE HISTORICALLY BEEN ASSOCIATED WITH RESIDUE FROM THE AMINO-OLEIC ACID (AOA) TREATMENT PROCESS; HOWEVER, NO ANALYTICAL TESTING WAS PERFORMED AS PART OF THIS EVALUATION, AND THE ORIGIN OF THE PARTICULATES WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REMOVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-29, RED RESIDUE WAS SEEN ON THE STENT FRAME AND ON THE LE AFLETS. SUBSEQUENTLY, A NEW VALVE WAS USED AND SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470088 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVFXPLUS-29 00763000920432

    Patients

    Seq Age Sex Outcome Treatment
    1