BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22346702 · Received June 27, 2025

    Report

    Report Number
    2025587-2025-04599
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000942717
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-34 (LOT: 0012291306); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE PRODUCT ID EVFXPLUS-34 (K072150); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE. 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. D4. 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 PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED DUE TO A BICUSPID AORTIC VALVE. THE VALVE WAS DEPLOYED AND RECAPTURED THREE TIMES. THE RECAPTURES WERE DUE TO A TOO HIGH AND TOO LOW DEPTH. ON A FINAL DEPLOYMENT ATTEMPT, BOTH TABS CAME OFF THE PADDLES SIMULTANEOUSLY AND ABRUPTLY CAUSING THE VALVE TO DISLODGE VENTRICULAR FROM A DEPTH OF 3 MM ON THE NON-CORONARY CUSP (NCC) AND 6 MM ON THE LEFT CORONARY CUSP (LCC) TO 8 MM ON THE NCC AND 12 MM ON THE LCC. PER THE PHYSICIAN, THE PADDLES FELT LOOSER IN THE POCKET THAN USUAL. NO INTERVENTION WAS REQUIRED AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC GUIDEWIRE WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939545 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-34 0012294211 00763000942717

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male SEE H11...