BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 22374118 · Received July 1, 2025

    Report

    Report Number
    2025587-2025-04675
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000822132
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-23 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-23 (K062189); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2025. 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 THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED TO 80% AT A DEPTH OF 8 MM ON THE NON-CORONARY CUSP. THIS DEPTH WAS NEAR THE INFLOW PORTION OF THE A PREVIOUSLY IMPLANTED NON-MEDTRONIC SURGICAL AORTIC VALVE. AT 80% DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE. THE VALVE WAS RECAPTURED AND RE-DEPLOYED TO 80%. THE PATIENT REMAINED HYPOTENSIVE AND ENTERED PULSELESS ELECTRICAL ACTIVITY ARREST. THE VALVE WAS COMPLETELY RECAPTURED AND PLACED IN THE DESCENDING AORTA. CARDIOPULMONARY RESUSCITATION (CPR) AND ADVANCED CARDIOVASCULAR LIFE SUPPORT PROTOCOL WERE INITIATED. A NEW VALVE WAS LOADED WITH A NEW DELIVERY CATHETER SYSTEM. THE PATIENT WAS INTUBATED, AFTER WHICH CHEST COMPRESSIONS WERE RESUMED. AFTER SEVERAL ROUNDS OF CPR, RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE NEW VALVE WAS IMPLANTED IN THE PATIENT. THE NEWLY IMPLANTED VALVE APPEARED UNDER-EXPANDED; HOWEVER, THIS EXPANSION ISSUE WAS NOTED TO HAVE BEEN EXPECTED. AS A RESULT, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 20 MM NON-MEDTRONIC BALLOON. CORONARY PERFUSION WAS CONFIRMED POST-IMPLANT BY SUCCESSFUL CORONARY CANNULATION. PER THE PHYSICIAN, FAVORABLE HEMODYNAMICS WERE ACHIEVED FOLLOWING THE PROCEDURE. THE PATIENT WAS EXTUBATED IMMEDIATELY FOLLOWING THE PROCEDURE. THE MEAN GRADIENT FOLLOWING VALVE IMPLANT WAS 12 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431118 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012740596 00763000822132

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| L SEE H11...