BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 22589242 · Received July 24, 2025

    Report

    Report Number
    2025587-2025-05254
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 22, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000979959
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012529123); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-29 (K013195); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (0012648576); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID D-EVOLUTFX-2329 (0012672023); PRODUCT TYPE: 0195-HEART VALVES. 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: B5. ADDED SECOND PARAGRAPH. 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 ATTEMPTED IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH VENTILATION DISORDER, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING AN 20 MM NON-MEDTRONIC BALLOON. DURING THE FIRST INFLATION, THE BALLOON SLIPPED. THE BALLOON SUCCESSFULLY INFLATED THE SECOND TIME; HOWEVER, AN INDENTATION WAS NOTED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED INTO THE PATIENT, ADVANCED TO THE ANNULUS, AND THE VALVE WAS DEPLOYED. UNDER-EXPANSION OF THE VALVE FRAME WAS OBSERVED. THE VALVE WAS RECAPTURED AND TWO MORE BALLOON DILATIONS WERE PERFORMED USING A 22 MM NON-MEDTRONIC BALLOON. SUBSEQUENTLY, THE VALVE WAS DEPLOYED A SECOND TIME AND AN INFOLD WAS CONFIRMED. THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A 26 MM VALVE WAS INSERTED INTO THE PATIENT AND DEPLOYED AT THE ANNULUS. IT WAS NOTED THAT THE EXPANSION OF THIS VALVE WAS POOR. DESPITE THE EXPANSION ISSUE, THE VALVE WAS FULLY RELEASED. THE NEW VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. A HEMORRHAGE AT THE ACCESS SITE WAS NOTED. HEMOSTASIS WAS PERFORMED USING A BALLOON. DURING HEMOSTASIS, A PSEUDOANEURYSM WAS OBSERVED IN THE EXTERNAL ILIAC ARTERY. A CUTDOWN PROCEDURE WAS CONSIDERED; HOWEVER, THE BLEEDING STOPPED AND THE PSEUDOANEURYSM DID NOT EXPAND. THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH VENTILATION DISORDER, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING AN 20 MM NON-MEDTRONIC BALLOON. DURING THE FIRST INFLATION, THE BALLOON SLIPPED. THE BALLOON SUCCESSFULLY INFLATED THE SECOND TIME; HOWEVER, AN INDENTATION WAS NOTED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED INTO THE PATIENT, ADVANCED TO THE ANNULUS, AND THE VALVE WAS DEPLOYED. UNDER-EXPANSION OF THE VALVE FRAME WAS OBSERVED. THE VALVE WAS RECAPTURED AND TWO MORE BALLOON DILATIONS WERE PERFORMED USING A 22 MM NON-MEDTRONIC BALLOON. SUBSEQUENTLY, THE VALVE WAS DEPLOYED A SECOND TIME AND AN INFOLD WAS CONFIRMED. THE VALVE WAS RECAPTURED AND WITHDRAWN FROM THE PATIENT. A 26 MM VALVE WAS INSERTED INTO THE PATIENT AND DEPLOYED AT THE ANNULUS. IT WAS NOTED THAT THE EXPANSION OF THIS VALVE WAS POOR. DESPITE THE EXPANSION ISSUE, THE VALVE WAS FULLY RELEASED. THE NEW VALVE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. A HEMORRHAGE AT THE ACCESS SITE WAS NOTED. HEMOSTASIS WAS PERFORMED USING A BALLOON. DURING HEMOSTASIS, A PSEUDOANEURYSM WAS OBSERVED IN THE EXTERNAL ILIAC ARTERY. A CUTDOWN PROCEDURE WAS CONSIDERED; HOWEVER, THE BLEEDING STOPPED AND THE PSEUDOANEURYSM DID NOT EXPAND. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO MISLOAD WAS IDENTIFIED DURING LOADING. THE RIGHT SIDE WAS USED FOR ACCESS AND THE MINIMUM SIDE OF THE ACCESS VESSEL WAS 5.1 X 5.6 MM. PER THE PHYSICIAN, ANATOMICAL FACTORS SUCH AS SEVERE CALCIFICATION AND A BORDERLINE ANNULUS SIZE CONTRIBUTED TO THE INFOLD. THE ACCESS SITE INJURY WAS NOT DISCOVERED UNTIL REMOVAL OF THE DCS. PER THE PHYSICIAN, CALCIFICATION CONTRIBUTED TO THE INJURY. THERE WAS A PROCEDURAL DELAY AS A RESULT OF THE INFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922123 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-26 00763000979959

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.