BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 24394201 · Received February 19, 2026

    Report

    Report Number
    9612164-2026-00918
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000944469
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10:  PRODUCT ID: L-EVOLUTFX-2329; (LOT: 0013090418); PRODUCT TYPE: 0195-HEART VALVES. PRODUCT ID: EVOLUTFX-29 (K061642); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2026; EXPLANT DATE (B)(6) 2026. 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

    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, TWO ATTEMPTS AT POSITIONING WERE UNSUCCESSFUL DUE TO THE VALVE DISLODGING, AND A FINAL IMPLANTATION DEPTH OF APPROXIMATELY 4 MILLIMETERS WAS ACCEPTED. DEPLOYMENT WAS PERFORMED SLOWLY AND UNDER RAPID PACING, BUT UPON RELEASE OF THE TABS, THE VALVE DISLODGED TOWARD THE VENTRICLE. ANGIOGRAPHIC AND ECHOCARDIOGRAPHIC ASSESSMENTS REVEALED SEVERE PARAVALVULAR LEAK (PVL). SUBSEQUENTLY, EXPLANT OF THE VALVE WAS REQUIRED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, TWO ATTEMPTS AT POSITIONING WERE UNSUCCESSFUL DUE TO THE VALVE DISLODGING, AND A FINAL IMPLANTATION DEPTH OF APPROXIMATELY 4 MILLIMETERS WAS ACCEPTED. DEPLOYMENT WAS PERFORMED SLOWLY AND UNDER RAPID PACING, BUT UPON RELEASE OF THE TABS, THE VALVE DISLODGED TOWARD THE VENTRICLE. ANGIOGRAPHIC AND ECHOCARDIOGRAPHIC ASSESSMENTS REVEALED SEVERE PARAVALVULAR LEAK (PVL). SUBSEQUENTLY, EXPLANT OF THE VALVE WAS REQUIRED, AND A SURGICAL AORTIC VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON DILATION WAS NOT PERFORMED AND A NON-MEDTRONIC GUIDEWIRE WAS USED FOR THE PROCEDURE. THE DEPLOYMENT STARTING POINT WAS AT THE BOTTOM OF THE PIGTAIL CATHETER. THE DEPTH ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC) AFTER DISPLACEMENT WAS APPROXIMATELY 20 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342222 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0013179479 00763000944469

    Patients

    Seq Age Sex Outcome Treatment
    1