BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 23458805 · Received November 3, 2025

    Report

    Report Number
    9612164-2025-05385
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000822132
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: EVFXPLUS-26 (K968974); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: N/A; EXPLANT DATE: N/A. 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 DATA: B5. 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 UPON 80% DEPLOYMENT OF A TRANSCATHETER VALVE, THE IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC) WAS 3-4 MILLIMETERS (MM). UPON FULL DEPLOYMENT, ONE OF THE OUTFLOW PADDLES WAS STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS), AND THE VALVE DISLODGED INTO THE SINUSES. SUBSEQUENTLY, THE NOSE CONE OF THE DCS WAS REMOVED WITHOUT ISSUE. CONTRAST IMAGING AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE PERFORMED THAT REVEALED THE VALVE REMAINED IN THE SINUSES. THE VALVE WAS SNARED AND PULLED UP INTO THE ASCENDING AORTA ABOVE THE SINOTUBULAR JUNCTION (STJ) WHILE A SECOND TRANSCATHETER VALVE WAS ATTEMPTED WITH A SECOND DCS. HOWEVER, THE SECOND DCS WAS UNABLE TO ADVANCE THROUGH THE FIRST VALVE AS THE NOSECONE WAS GETTING CAUGHT ONTO THE LEAFLETS, AND THE FIRST VALVE FURTHER DISLODGED INTO THE SINUSES. AFTER 4-5 ATTEMPTS ADVANCING THE DCS, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED THAT REVEALED A DISSECTION AT THE STJ PROPAGATING INTO THE SINUSES. SUBSEQUENTLY, THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY TO ADDRESS THE DISSECTION AND EXPLANT THE TRANSCATHETER VALVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION, PER THE PHYSICIAN, INDICATED THE MEDTRONIC GUIDEWIRE DID NOT CAUSE OR CONTRIBUTE TO THE VALVE DISLODGEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE DISLODGE WAS DUE TO LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION AND MITRAL ANNULAR CALCIFICATION. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. A MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION WAS DUE TO THE VALVE BEING PUSHED DOWN WHILE ATTEMPTING TO ADVANCE THE SECOND DCS THROUGH THE DISLODGED VALVE. PER THE PHYSICIAN, THE FIRST DISLODGED VALVE AND SECOND DCS CAUSED/CONTRIBUTED TO THE DISSECTION. IT WAS NOTED THAT THE PATIENT HAD LARGE SINUSES AND AORTIC ROOT THAT CONTRIBUTED TO THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067036 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012964898 00763000822132

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Life Threatening| H| R SEE H11...