BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 21994504 · Received May 9, 2025

    Report

    Report Number
    2025587-2025-03560
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 20, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED WITH A VALVE LOADED WITHIN THE CAPSULE. THE DEVICE WAS RECEIVED WITH THE NOSECONE OVER-CAPTURED BY THE CAPSULE. THE CAPSULE APPEARED INTACT WITH NO EVIDENCE OF DAMAGE. THERE WAS A BEND TO THE STABILITY SHAFT. THE HANDLE APPEARED INTACT. THE DEVICE WAS RETURNED WITH THE END CAP/SCREW GEAR SNAP FIT CONNECTED. A 0.035-INCH GUIDEWIRE WAS UNABLE TO BE BACKLOADED PAST THE INNER MEMBER SHAFT WITH THE RETURNED VALVE IN THE CAPSULE. THE BLOCKAGE WAS LOCATED 152.4CM DISTAL TO THE WIRE LUMEN FLUSH PORT. RULER CAL. NO. 802290. ON RETRACTION OF THE CAPSULE VIA THE ROTATION OF THE ACTUATOR, THE RETURNED VALVE DEPLOYED WITH A CROWN OVERLAP. FLATTENING WAS VISIBLE TO THE DISTAL SECTION OF THE INNER MEMBER SHAFT. THE SPINDLE HUB APPEARED INTACT WITH NO EVIDENCE OF DAMAGE. A 0.035-INCH GUIDEWIRE WAS ABLE TO BE BACKLOADED THROUGH THE DCS WITH RESISTANCE NOTED DUE TO THE INNER MEMBER SHAFT FLATTENING. THE REPORTED EVENT FOR INTERACTION ISSUES WITH GUIDEWIRE COULD BE CONFIRMED IN THE ANALYSIS. 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

    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 IMPLANT PROCEDURE, A VALVE FOLD TO THE SECOND NODE WAS NOTED AFTER BEING LOADED AND CHECKED BY FLUOROSCOPY. WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE NON-MEDTRONIC (SAFARI) GUIDEWIRE THROUGH THE DELIVERY CATHETER SYSTEM (DCS), RESISTANCE WAS ENCOUNTERED, AND THE WIRE WOULD NOT ADVANCE. THE GUIDEWIRE WAS INSPECTED AND FOUND TO HAVE NO ISSUES. THE SYSTEM WAS NOT INSERTED INTO THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DCS WITH A NEW LOADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035340 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012631050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown