BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 24557049 · Received March 10, 2026

    Report

    Report Number
    9617601-2026-01694
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000370633
    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

    UPDATED DATA: B5. H6. ADDITIONAL CODES. H6. THE CODES PRESENT IN SECTION H6. CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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 EVOLUTFX-34 (R227128); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE. PRODUCT ID EVOLUTFX-26 (R204958); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE. PRODUCT ID EVOLUTFX-34 (R231870); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE. PRODUCT ID EVOLUTFX-29 (K953137); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE. PRODUCT ID EVOLUTFX-29 (K950191); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE. PRODUCT ID EVOLUTFX-26 (K007873); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE 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

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THAT THESE VALVES WERE OPENED DURING THREE DIFFERENT PROCEDURES. THERE WAS DIFFICULTY OPENING THE VALVE JARS AND DAMAGE TO THE JAR LID SEALS WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE TRANSCATHETER BIOPROSTHETIC VALVES EXHIBITED A SEAL ISSUE AND WHITE LOOSE PARTICLES WERE VISIBLE AFTER OPENING THE JAR LID. THE VALVES WERE NOT USED FOR IMPLANT AND WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623756 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-34 00763000370633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...