BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22750249 · Received August 8, 2025

    Report

    Report Number
    9612164-2025-03899
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000365714
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVFXPLUS-29 (K953212); 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 H.6 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: B5, H8. 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 TRANSCATHETER BIOPROSTHETIC VALVE, DURING DEPLOYMENT, THE VALVE DISLODGED INTO THE ASCENDING AORTA. AS A RESULT, THE VALVE WAS RECAPTURED AND RE-POSITIONED. AS THE VALVE WAS RE-POSITIONED, AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM AND SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WAS A PROCEDURAL DELAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING DEPLOYMENT, THE VALVE DISLODGED INTO THE A SCENDING AORTA. AS A RESULT, THE VALVE WAS RECAPTURED AND RE-POSITIONED. AS THE VALVE WAS RE-POSITIONED, AN INFOLD WAS OBSERVED. SUBSEQUENTLY, THE VALVE WAS WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS LOADED INTO A NEW DELIVERY CATHETER SYSTEM AND SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WAS A PROCEDURAL DELAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS NOT PERFORMED AND A NON-MEDTRONIC (SAFARI) GUIDEWIRE WAS USED FOR THE PROCEDURE. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162620 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012779394 00763000365714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown