BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22096868 · Received May 28, 2025

    Report

    Report Number
    2025587-2025-03920
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    January 22, 2025
    Report Date
    May 28, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MASANORI YAMAMOTO ET AL. DEVELOPMENT OF AN ALGORITHM TO OPTIMIZE PERCUTANEOUS CORONARY INTERVENTION THROUGH SUPRA-ANNULAR SELF-EXPANDABLE TRANSCATHETER HEART VALVE. JACC CASE REP. MAR 19;30(6 PT 1):102990. 2025. 10.1016/J.JACCAS.2024.102990. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING OPTIMIZATION OF PERCUTANEOUS CORONARY INTERVENTION THROUGH SUPRA-ANNULAR SELF-EXPANDABLE TRANSCATHETER HEART VALVE.  IN ONE OF TWO CASES DESCRIBED BY THE AUTHORS, A PATIENT WITH SEVERE AORTIC STENOSIS AND ISCHEMIA OF THE RIGHT CORONARY ARTERY (RCA) UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH PLANNED CORONARY STENT PLACEMENT.  FIRST, A MEDTRONIC 26-MM EVOLUT FX BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED IN THE AORTIC POSITION.  NEXT, DURING THE ATTEMPTED CORONARY STENT PLACEMENT, A VALVE FRAME STRUT WAS NOTED AS OCCLUDING THE RCA OSTIA.  A VIRTUAL REALITY SIMULATION SYSTEM WAS THEN USED TO VISUALIZE THE IDEAL CURVE OF THE INNER CATHETER FOR THE SUCCESSFUL RCA ACCESS AND STENT PLACEMENT.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332034 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L