BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 25331333 · Received May 29, 2026

    Report

    Report Number
    9612164-2026-02808
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000942700
    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

    A. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. D10. CONTINUATION - CONCOMITANT MEDICAL DEVICES IN USE DURING THE EVENT INCLUDE: MEDTRONIC PRODUCT ID: EVFXPLUS-29; SERIAL #: (B)(6); UBD: (01)00763000979966(17)280110(21)R267636; IMPLANT DATE: NOT IMPLANTED H6. THE CODES PRESENT IN SECTION H6. CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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, DURING PREPARATION FOR THE ATTEMPTED IMPLANT OF THIS 29MM TRANSCATHETER AORTIC BIOPROSTHETIC VALVE (TAV) (R060870), IN A PATIENT WITH A TYPE 0 BICUSPID NATIVE VALVE, AFTER THE TAV WAS LOADED INTO THE DELIVERY CATHETER SYSTEM (DCS) (0013259439) BY AN INEXPERIENCED VALVE LOADER, THE VALVE LOAD WAS REVIEWED VIA FLUOROSCOPIC INSPECTION AND A MISLOAD WAS IDENTIFIED. THE MISLOAD WAS FURTHER CHARACTERIZED AS A BENT STRUT IN THE TAV FRAME WITH NO NODE INVOLVEMENT. THE TAV AND DCS WERE NOT USED FOR THE PROCEDURE. A PRE-IMPLANT BALLOON DILATION WAS PERFORMED AND A SECOND 29MM TAV (R267636) AND DCS (0013259439) WERE LOADED WITHOUT ISSUE. THE DCS WAS INSERTED INTO THE PATIENT¿S VASCULATURE AND ADVANCED TO THE AORTIC ANNULUS. THREE DEPLOYMENT ATTEMPTS WERE MADE; HOWEVER, THE TAV WOULD DISLODGE AND COULD NOT BE IMPLANTED. THE TAV WAS RECAPTURED INTO THE DCS. A DECISION TO ATTEMPT A SMALLER TAV WAS MADE; THEREFORE, THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A THIRD, SMALLER 26MM TAV (R234758) WAS LOADED INTO A THIRD DCS (0013092710) WITHOUT ISSUE. THE DCS WAS INSERTED INTO THE PATIENT¿S VASCULATURE AND ADVANCED TO THE AORTIC ANNULUS; HOWEVER, THE TAV ALSO DISLODGED DURING THREE SEPARATE DEPLOYMENT ATTEMPTS AND OPTIMAL TAV PLACEMENT COULD NOT BE ACHIEVED. THE TAV WAS RECAPTURED INTO THE DCS AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. SUBSEQUENTLY, A 26MM NON-MEDTRONIC (SAPIEN3 UE) TAV WAS USED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT'S BICUSPID VALVE WAS A CONTRIBUTING FACTOR TO THE INABILITY TO PLACE THE MEDTRONIC VALVES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232538 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0013092710 00763000942700

    Patients

    Seq Age Sex Outcome Treatment
    1