BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22739122 · Received August 7, 2025

    Report

    Report Number
    9612164-2025-03884
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVOLUTFX-23 (K051148); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE N/A 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. 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 UPON DEPLOYMENT OF A 23 MILLIMETER (MM) TRANSCATHETER VALVE IN A PATIENT WITH AN ANNULAR PERIMETER OF 67 MM, THE VALVE WAS POSITIONED SLIGHTLY DEEP AT AN IMPLANT DEPTH OF 5 MM ON THE NON-CORONARY CUSP (NCC), AND 8 MM ON THE LEFT CORONARY CUSP (LCC). AN ATTEMPT WAS MADE TO RECAPTURE THE VALVE; HOWEVER, THE VALVE COULD NOT BE RECAPTURED DUE TO THE VALVE FRAME. SUBSEQUENTLY, THE VALVE WAS FULLY DEPLOYED. FOLLOWING THE IMPLANT OF THE VALVE, MILD TO MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON DEPLOYMENT OF A 23 MILLIMETER (MM) TRANSCATHETER VALVE IN A PATIENT WITH AN ANNULAR PERIMETER OF 67 MM, THE VALVE WAS POSITIONED SLIGHTLY DEEP AT AN IMPLANT DEPTH OF 5 MM ON THE NON-CORONARY CUSP (NCC), AND 8 MM ON THE LEFT CORONARY CUSP (LCC). AN ATTEMPT WAS MADE TO RECAPTURE THE VALVE; HOWEVER, THE VALVE COULD NOT BE RECAPTURED DUE TO THE VALVE FRAME. SUBSEQUENTLY,THE VALVE WAS FULLY DEPLOYED. FOLLOWING THE IMPLANT OF THE VALVE, MILD TO MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO TREATMENT WAS PERFORMED FOR THE PVL. THERE WAS NOTHING REGARDING THE PATIENT ANATOMY THAT CONTRIBUTED TO THE POSITIONING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219388 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012342653 00763000365677

    Patients

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