BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX DCS

    MDR report key: 21454975 · Received February 24, 2025

    Report

    Report Number
    2025587-2025-01434
    Event Type
    Death
    Date Received
    February 24, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 24, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID L-EVOLUTFX-2329 (LOT: UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; NON-IMPLANTABLE DEVICE PRODUCT ID EVFXPLUS-29 (K002740); PRODUCT TYPE: 0195-HEART VALVES. 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 A TRANSCATHETER AORTIC VALVE PROCEDURE INVOLVING THE EVFXPLUS-29 IN A PATIENT WITH TORTUOUS AND CALCIFIED ANATOMY, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED DUE TO CALCIFICATION. THE VALVE WAS INITIALLY DEPLOYED TO 80% BUT EXHIBITED INFOLDING ALONG ITS ENTIRE LENGTH. IT WAS ALSO NOTED THAT THE IMPLANT DEPTH WAS TOO SHALLOW. SUBSEQUENTLY, THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS) AND WITHDRAWN FROM THE PATIENT. A SECOND VALVE WAS THEN LOADED INTO A NEW DCS BUT WAS UNABLE TO CROSS THE NATIVE VALVE DESPITE EMPLOYING VARIOUS TECHNIQUES. THE PATIENT COULD NOT TOLERATE THE AORTIC INSUFFICIENCY, BECAME ISCHEMIC, AND EXPERIENCED CARDIAC ARREST, ULTIMATELY RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045731 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012463872 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Death