BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 21732937 · Received March 31, 2025

    Report

    Report Number
    2025587-2025-02243
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    October 23, 2024
    Report Date
    March 31, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: NIENABER S, CURIO J, LEE S, ET AL. TAVR-IN-TAVR FOR EARLY DEGENERATION OF A NOVEL SELF-EXPANDABLE VALVE DEDICATED TO TREATMENT OF AORTIC REGURGITATION. JACC CARDIOVASC INTERV. 2024;17(22):2698-2700. DOI:10.1016/J.JCIN.2024.08.015 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 A PATIENT WHO HAD A MEDTRONIC 26 MM EVOLUT FX TRANSCATHETER AORTIC VALVE IMPLANTED VALVE-IN-VALVE IN A DETERIORATED NON-MEDTRONIC TRANSCATHETER VALVE (JENAVALVE). IN THEIR ACCOUNT OF THE PROCEDURE, THE AUTHORS WROTE THAT THE EVOLUT FX VALVE WAS ¿POSITIONED AND DEPLOYED AS INTENDED.¿ AFTERWARD, A POST-DILATION WAS PERFORMED WITH A NON-MEDTRONIC 22 MM BALLOON (TRUE/LOMAVISTA) TO FULLY EXPAND THE VALVE FRAME. THEN ANGIOGRAPHY SHOWED COMPROMISED CORONARY FLOW, PROMPTING THE DEPLOYMENT OF STENTS THAT HAD BEEN PLACED IN THE RIGHT AND LEFT CORONARY ARTERIES AT THE OUTSET OF THE PROCEDURE AS A PROTECTIVE MEASURE. ULTIMATELY, THE AUTHORS RECORDED GOOD CORONARY FLOW AND PROPER VALVE-IN-VALVE POSITIONING WITH NO PARAVALVULAR LEAK AND A GRADIENT OF 5 MMHG. AS DOCUMENTED IN THE ARTICLE, ¿THE PATIENT WAS DISCHARGED IN GOOD CONDITION, AND AN EXCELLENT OUTCOME WAS CONFIRMED AT THE 30-DAY FOLLOW-UP.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055152 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention