BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22329919 · Received June 25, 2025

    Report

    Report Number
    2025587-2025-04522
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    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

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-34 (LOT: 0012460571); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVFXPLUS-34 (K003110); 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 DATA: B5, ADDED SECOND PARAGRAPH, ADDITIONAL CODES. 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 IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH AN AORTIC ROOT ANGLE OF 78 DEGRE ES, AN ANNULUS PERIMETER OF 78 MM, AND A SINUS OF VALSALVA DIAMETER OF APPROXIMATELY 33 MM, THE VALVE WAS EXPANDED DURING DEPLOYMENT TO 80%. THE EXPANDING VALVE WAS EXPOSED TO BLOOD FLOW WHICH CAUSED THE DEVICE TO DISLODGE. THE VALVE WAS RECAPTURED. DURING A SECOND ATTEMPT AT DEPLOYMENT, AN INFOLD WAS OBSERVED IN THE VALVE FRAME AT A DEPTH OF 0 MM ON THE NON-CORONARY CUSP (NCC) AND 1 MM ON THE LEFT CORONARY CUSP (LCC). IT WAS SUSPECTED THAT THE INFOLD OCCURRED DURING THE RECAPTURE. A NEW VALVE WAS LOADED AND SUCCESSFULLY IMPLANTED AT A DEPTH OF 1 MM ON THE NCC AND 3 MM ON THE LCC. 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 IN A PATIENT WITH AN AORTIC ROOT ANGLE OF 78 DEGREES, AN ANNULUS PERIMETER OF 78 MM, AND A SINUS OF VALSALVA DIAMETER OF APPROXIMATELY 33 MM, THE VALVE WAS EXPANDED DURING DEPLOYMENT TO 80%. THE EXPANDING VALVE WAS EXPOSED TO BLOOD FLOW WHICH CAUSED THE DEVICE TO DISLODGE. THE VALVE WAS RECAPTURED. DURING A SECOND ATTEMPT AT DEPLOYMENT, AN INFOLD WAS OBSERVED IN THE VALVE FRAME AT A DEPTH OF 0 MM ON THE NON-CORONARY CUSP (NCC) AND 1 MM ON THE LEFT CORONARY CUSP (LCC). IT WAS SUSPECTED THAT THE INFOLD OCCURRED DURING THE RECAPTURE. A NEW VALVE WAS LOADED AND SUCCESSFULLY IMPLANTED AT A DEPTH OF 1 MM ON THE NCC AND 3 MM ON THE LCC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT, PRIOR TO DISLODGEMENT THE VALVE WAS DEPLOYED BOTTOM OF PIGTAIL AT A DEPTH OF 1 MM ON THE NCC AND 3 MM ON THE LCC. THE VALVE DISLODGED IN THE AORTIC DIRECTION TO THE SAME DEPTH. OF NOTE, A NON-MEDTRONIC GUIDEWIRE WAS USED AND A PROCEDURAL DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484462 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-34 0012294211

    Patients

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