BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 21738366 · Received April 1, 2025

    Report

    Report Number
    2025587-2025-02252
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 3, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVOLUTFX-23 ((B)(6)); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTFX-26 ((B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025. 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

    UPDATED DATA: D4. H4. 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 HEART VALVE PROCEDURE, VASCULAR ACCESS WAS OBTAINED IN THE RIGHT RADIAL ARTERY AND LEFT FEMORAL VEIN, WITH THE PLACEMENT OF INTRODUCERS AND A TEMPORARY PACEMAKER. AN ULTRASOUND-GUIDED PUNCTURE IN THE LEFT COMMON FEMORAL ARTERY WAS PERFORMED, AND AN 8FR VALVED INTRODUCER WAS POSITIONED, LATER EXCHANGED FOR A 12 FR INTRODUCER. PERCUTANEOUS REPAIR WAS CONDUCTED WITH TWO VASCULAR CLOSURE DEVICES. THE IMPLANTATION OF A 23 MILLIMETER EVOLUT FX AORTIC BIOPROSTHESIS WAS ATTEMPTED BUT UNSUCCESSFUL DUE TO INSTABILITY, RESULTING IN THE PROSTHESIS DISLODGING TO THE VENTRICLE WITH THREE ATTEMPTS, NECESSITATING RECAPTURE. SUBSEQUENTLY, A 26 MILLIMETER EVOLUT FX AORTIC BIOPROSTHESIS WAS SUCCESSFULLY IMPLANTED USING AN IN-LINE SYSTEM, GUIDED BY FLUOROSCOPY AND TRANSTHORACIC ECHOCARDIOGRAPHY. PRESSURE MEASUREMENTS IN THE ASCENDING AORTA AND LEFT VENTRICLE SHOWED A GRADIENT OF 4 MMHG. HEMOSTASIS WAS ACHIEVED WITH TWO SUTURE-MEDIATED VASCULAR CLOSURE DEVICES AND ONE 8FR VASCULAR CLOSURE DEVICE AFTER SHEATH REMOVAL FROM THE LEFT FEMORAL ARTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954623 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012483141 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female SEE H11...