BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 23923089 · Received December 30, 2025

    Report

    Report Number
    9612164-2025-06429
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 29, 2025
    Report Date
    January 2, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000942700
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. CONTINUATION OF D10: PRODUCT ID EVFXPLUS-29 (R042277); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2025. 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., 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER VALVE, THE HEIGHT OF IMPLANT WAS OPTIMAL AND THE PATIENT WAS HEMODYNAMICALLY STABLE; HOWEVER, MILD PARAVALVULAR LEAK (PVL) WAS OBSERVED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 24 MILLIMETER (MM)/40 CENTIMETER NON-MEDTRONIC BALLOON. THE AORTIC VALVE WAS CROSSED AND THE BALLOON WAS INSERTED OVER THE GUIDEWIRE. AFTER DEFLATING THE BALLOON, THE BALLOON WAS DIFFICULT TO REMOVE AND THE VALVE DISLODGED. PER THE PHYSICIAN, THE CAUSE OF THE DISLODGE COULD HAVE BEEN DUE TO THE WIRE ENTERING THE STRUTS OF THE VALVE CAUSING THE BALLOON TO GET STUCK. THEREFORE, THE DISLODGED VALVE WAS SNARED. A NEW VALVE WAS PREPARED WITH A NEW DELIVERY CATHETER SYSTEM (DCS), AND THE SECOND VALVE WAS IMPLANTED. FOLLOWING THE IMPLANT OF THE SECOND VALVE, A SMALL ASCENDING AORTIC DISSECTION WAS OBSERVED. PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION MAY HAVE BEEN DUE TO MANIPULATION OF THE FIRST VALVE WITH THE SNARE AND ADVANCING THE SECOND VALVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NOTHING OF NOTE IN TERMS OF PATIENT ANATOMY THAT CONTRIBUTED TO THE DISLODGEMENT. THE DEPLOYMENT STARTING POINT WAS THE BOTTOM OF THE PIGTAIL. THE DIRECTION OF THE DISLODGEMENT WAS AORTIC. PRIOR TO THE VALVE DISLODGING, THE IMPLANT DEPTH ON THE NON-CORONARY CUSP (NCC) AND THE LEFT CORONARY CUSP (LCC) WAS NOTED TO BE ABOUT 5 MILLIMETER (MM). AFTER THE DISLODGEMENT, THE FIRST VALVE WAS NOTED TO BE IN THE ASCENDING AORTA. THE DISSECTION WAS NOTED AT THE END OF THE PROCEDURE. PER THE PHYSICIAN, THE MOST LIKELY CAUSE OF THE DISSECTION WAS THE MANIPULATION WITH THE SNARE AND THE FIRST VALVE. PER THE PHYSICIAN, THE FIRST VALVE MIGHT HAVE CAUSED OR CONTRIBUTED TO THE DISSECTION. PER THE PHYSICIAN, THE SECOND VALVE DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. PER THE PHYSICIAN, THE FIRST DELIVERY CATHETER SYSTEM (DCS) DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. PER THE PHYSICIAN, THE SECOND DCS DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. THERE WAS NO UNUSUAL TREATMENT PROVIDED. THE SAME TREATMENT AS ANY VALVE IMPLANT PROCEDURE WAS USED. THERE WAS NOTHING OF NOTE IN TERMS OF PATIENT ANATOMY THAT CONTRIBUTED TO THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002193 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012294209 00763000942700

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention| L SEE H11...