BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 17472411 · Received August 7, 2023

    Report

    Report Number
    2025587-2023-03235
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 7, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZAID S, ATTIZZANI GF, KRISHNAMOORTHY P, ET AL. FIRST-IN-HUMAN MULTICENTER EXPERIENCE OF THE NEWEST GENERATION SUPRA-ANNULAR SELF-EXPANDING EVOLUT FX TAVR SYSTEM. JACC CARDIOVASC INTERV. 2023;16(13):1626-1635. DOI:10.1016/J.JCIN.2023.05.004 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE FIRST-IN-HUMAN EXPERIENCE OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH THE LATEST-GENERATION SELF-EXPANDING VALVE SYSTEM. THE STUDY POPULATION CONSISTED OF 226 PATIENTS WHO UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT FX SYSTEM. THE AUTHORS OBSERVED A TOTAL OF FIVE ALL-CAUSE DEATHS WITHIN 30 DAYS OF TAVR, INCLUDING TWO IN-HOSPITAL MORTALITIES. ONE OF THE IN-HOSPITAL MORTALITIES WAS RELATED TO VALVE MIGRATION AND ASCENDING AORTIC DISSECTION. OTHER IN-HOSPITAL AND 30-DAY OUTCOMES WERE DESCRIBED AS FOLLOWS: SECOND VALVE REQUIRED (FIRST VALVE MIGRATED IN THE AORTIC DIRECTION DURING DELIVERY SYSTEM RETRIEVAL NECESSITATING THE IMPLANT OF A SECOND EVOLUT FX IN THE INTENDED POSITION); STROKE; MAJOR VASCULAR COMPLICATION (UNSPECIFIED); NEW LEFT BUNDLE BRANCH BLOCK; NEW PERMANENT PACEMAKER IMPLANTATION; PARAVALVULAR AORTIC REGURGITATION (TRACE, MILD, OR MODERATE); TRANSVALVULAR AORTIC REGURGITATION (TRACE OR MILD); AND ELEVATED PEAK GRADIENT. SEPARATELY, THE AUTHORS COMPARED THE DELIVERY AND IMPLANTATION PERFORMANCE OF THE EVOLUT FX SYSTEM TO THE EVOLUT PRO+ SYSTEM AND OBSERVED MORE SYMMETRICAL IMPLANTATION, FEWER DEVICE RECAPTURES (VALVE RECAPTURED AND REPOSITIONED), AND IMPROVED COMMISSURAL ALIGNMENT WITH THE FX SYSTEM. NO FURTHER INFORMATION PERTAINING TO M EDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338123 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| L