BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22513110 · Received July 15, 2025

    Report

    Report Number
    2025587-2025-05046
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 2, 2025
    Report Date
    October 9, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000370619
    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

    CONTINUATION OF D10: PRODUCT ID EVOLUTFX-29 (K004371); 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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RECEIVED IN ITS ORIGINAL PRODUCT PACKAGING. THE OUTER PACKAGING SHOWED NO DAMAGES. THE JAR SAFETY SEAL WAS BROKEN. DUE TO THE RECEIPT CONDITION, A TORQUE ASSESSMENT TO EVALUATE AGAINST THE ¿DIFFICULT TO OPEN JAR¿ ALLEGATION COULD NOT BE PERFORMED. IT IS POSSIBLE A READING FROM THE TORQUE TESTER WOULD BE UNRELIABLE AS THE JAR HAS BEEN PREVIOUSLY OPENED. THERE WAS GASKET REMNANTS ON THE RIM OF THE JAR. CRYSTALLIZED, DRIED GLUTARALDEHYDE WAS PRESENT ALONG THE THREADS OF THE JAR. THERE WERE LOOSE PIECES OF GASKET NOTED ON THE RIM AND/OR OUTSIDE OF THE JAR. WHITE PARTICULATE WAS PRESENT IN THE JAR. THERE WAS NO DAMAGE ON THE THREADS OF THE LID. SMALL PITS WERE OBSERVED IN THE RUBBER ALONG APPROXIMATELY 1/4TH OF THE GASKET¿S CIRCUMFERENCE, CONSISTENT WITH REMNANTS OF GASKET FOUND ON THE JAR RIM. LOOSE PIECES OF GASKET WERE NOTED INSIDE OF THE LID. THE TEMPERATURE INDICATOR WAS NOT ACTIVATED. WHITE PARTICULATE WAS FOUND IN THE JAR AND/OR LID UPON OPENING. FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS WAS PERFORMED TO CONFIRM THE WHITE PARTICULATES WERE FROM THE GASKET INSIDE THE LID. AS A RESULT, NO FURTHER PARTICULATE ANALYSIS IS REQUIRED; A VISUAL INSPECTION USING A MICROSCOPE AT 10X MAGNIFICATION IS SUFFICIENT. 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.

    Additional Manufacturer Narrative · 0

    UPDATED B.5 AND 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

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AT TWO DIFFERENT PROCEDURES ON THE SAME DAY, BROKEN SEALING RINGS WERE OBSERVED. WHITE PARTICLES WERE VISIBLE ON THE GLASS GASKET AFTER OPENING THE JAR. SUBSEQUENTLY THE VALVES WERE REPLACED WITH NEW VALVES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT DIFFICULTY OPENING THE VALVE JARS RESULTED IN THE WHITE, LOOSE PARTICULATE FROM THE JAR LIDS. THERE WERE NO DAMAGES TO THE JAR LID SEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138221 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26 00763000370619

    Patients

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