BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 23373184 · Received October 23, 2025

    Report

    Report Number
    9612164-2025-05250
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 13, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000942717
    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-34}; PRODUCT LOT/SERIAL NUMBER {R001518}; PRODUCT TYPE: {0195-HEARTVALVES}; 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: 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 PRIOR TO THE IMPLANT OF A TRANSCATHETER AORTIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. FOLLOWING INSERTION INTO THE RIGHT FEMORAL ARTERY, WHICH HAD A MINIMUM DIAMETER OF 6.4 MILLIMETER¿S (MM), THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO BE ADVANCED AT THE RIGHT EXTERNAL ILIAC ARTERY. SUBSEQUENTLY, AN ACCESS SITE DISSECTION WAS OBSERVED. A BALLOON ANGIOPLASTY AND A NON-MEDTRONIC 8 MM X 60 MM STENT PLACEMENT WERE PERFORMED TO TREAT THE DISSECTION. IT WAS NOTED THAT THE PROCEDURE WAS DELAYED 30 MINUTES AS A RESULT OF THE TREATMENT. PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION WAS DUE TO INTERACTION OF THE DCS AND CALCIUM IN THE RIGHT EXTERNAL ILIAC ARTERY. ULTIMATELY, IT WAS DECIDED THAT THE PROCEDURE WOULD BE ABORTED AND THAT THE PATIENT WOULD RETURN AT A LATER DATE FOR A TRANSCATHETER AORTIC VALVE IMPLANT WITH AN ALTERNATE ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931660 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-34 0012792526 00763000942717

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention SEE H11.