BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22328334 · Received June 25, 2025

    Report

    Report Number
    2025587-2025-04506
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: EVFXPLUS-26; PRODUCT SERIAL NUMBER: K092204; PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2025, PRODUCT ID: L-EVOLUTFX-2329; PRODUCT LOT NUMBER: UNKNOWN; PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE PRODUCT ID: BOSTON SCIENTIFIC SAFARI GUIDEWIRE (NON-MEDTRONIC DEVICE); LOT #: UNKNOWN. 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 DCS WAS RECEIVED WITHOUT A VALVE LOADED WITHIN THE CAPSULE. THE DEVICE WAS RECEIVED WITH THE HANDLE AND FULLY CLOSED. THE DEVICE WAS RECEIVED WITH THE NOSECONE OVER-CAPTURED BY THE CAPSULE. KINK EVIDENT ON THE PROXIMAL END OF INNER MEMBER. THE HANDLE APPEARED TO RETRACT AND ADVANCE THE CAPSULE. THE TRIGGER MOVED TO FULLY ADVANCED AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. THE DEVICE WAS RECEIVED WITH THE OUTER COIL OF NON- MEDTRONIC GUIDE WIRE ENTRAPPED WITHIN THE WIRE LUMEN FLUSH PORT. A SECOND NON-MEDTRONIC GUIDE WIRE WAS ALSO RECEIVED ENTANGLED WITH THE TRAPPED GUIDE WIRE AND WAS UNTANGLED WITH NO ISSUES. IT IS NOT POSSIBLE TO REMOVE THE ENTRAPPED SECTION OF THE OUTER COIL OF THE GUIDE WIRE. THERE IS NO OTHER DEFORMATION EVIDENT TO THE REMAINDER OF THE DEVICE. THE REPORTED GUIDE WIRE INTERACTION ISSUES COULD BE CONFIRMED THROUGH ANALYSIS. UPDATED DATA: D4, D9, H3, H6. 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: H6 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 A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, THERE WAS TENSION NOTED WHEN ATTEMPTING TO REMOVE THE NON-MEDTRONIC GUIDEWIRE FROM THE DELIVERY CATHETER SYSTEM (DCS), AND THE WIRE COULD NOT BE REMOVED TO ALLOW REPLACEMENT WITH A SOFTER WIRE. THE DCS AND GUIDEWIRE WERE REMOVED TOGETHER, AT WHICH POINT IT WAS DISCOVERED THAT THE WIRE WAS STUCK IN THE DCS. THIS DID NOT INTERFERE WITH THE IMPLANTATION OF THE VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368743 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012752489 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female