BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 22177760 · Received June 10, 2025

    Report

    Report Number
    2025587-2025-04157
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 16, 2025
    Report Date
    August 4, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365684
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: EVFXPLUS-34 (K069135); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2025; EXPLANT DATE: NA. 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

    ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. UPDATED DATA: B2. B5. ADDED SECOND PARAGRAPH. D4. H4. H6. H11. 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

    CORRECTED DATA 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 A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO A BICUSPID AORTIC VALVE. DURING THE DEPLOYMENT OF THE VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, AND A TRACE LEAK OCCURRED. APPROXIMATELY 16 DAYS FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, THE PATIENT WAS HOSPITALIZED AND AN ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH REVEALED THE VALVE HAD FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL) AND HAD MIGRATED, CAUSING SEVERE CIRCUMFERENTIAL AORTIC INSUFFICIENCY (AI). PER THE PHYSICIAN, THE DEPTH OF THE IMPLANT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO A BICUSPID AORTIC VALVE. DURING THE DEPLOYMENT OF THE VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, AND A TRACE LEAK OCCURRED. APPROXIMATELY 16 DAYS FOLLOWING THE IMPLANT OF THE TRANSCATHETER VALVE, THE PATIENT WAS HOSPITALIZED AND AN ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH REVEALED THE VALVE HAD FAILED DUE TO A SEVERE PARAVALVULAR LEAK (PVL) AND HAD MIGRATED, CAUSING SEVERE CIRCUMFERENTIAL AORTIC INSUFFICIENCY (AI). PER THE PHYSICIAN, THE DEPTH OF THE IMPLANT CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DURING THE PROCEDURE TRACE PVL WAS OBSERVED. THE VALVE WAS INITIALLY IMPLANTED AT A DEPTH OF 4 MM ON THE NON-CORONARY CUSP (NCC) AND 4 MM ON THE LEFT CORONARY CUSP (LCC), BUT IT DISLODGED VENTRICULAR TO 10 MM ON THE NCC AND 11 MM ON THE LCC. THIS DISLODGE OCCURRED AFTER FULL DEPLOYMENT WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633539 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-34 0012358638 00763000365684

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| L| R SEE H11.