BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 21663420 · Received March 21, 2025

    Report

    Report Number
    2025587-2025-02025
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 21, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HUBER MP, MAITAS OL, ELISON DM, ET AL. USE OF A BARE METAL DISSECTION STENT TO MANAGE AORTIC EMBOLIZATION OF A SELF-EXPANDING VALVE. JACC CASE REP. 2025;30(3):103128. PUBLISHED 2025 FEB 5. DOI:10.1016/J.JACCAS.2024.103128. 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 UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A MEDTRONIC 29 MM EVOLUT FX VALVE. AT THE BEGINNING OF THE PROCEDURE, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH A 22 MM NON-MEDTRONIC (BD TRUE) NON-COMPLIANT BALLOON DUE TO THE SEVERE CALCIFICATION AND HIGH TRANSAORTIC GRADIENT. THEN THE AUTHORS RECOUNTED THAT THE EVOLUT FX VALVE WAS DEPLOYED ¿AT THE DESIRED DEPTH OF 3 MM BELOW THE NONCORONARY CUSP,¿ BUT IMMEDIATELY AFTER DEPLOYMENT AND BEFORE ANY MANIPULATION OF THE DELIVERY SYSTEM, THE VALVE EMBOLIZED TO THE ASCENDING AORTA. AFTERWARD, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS PLACED UNDER GENERAL ANESTHESIA. ¿BECAUSE THERE HAD BEEN NO INTERACTION WITH THE VALVE BEFORE ITS EMBOLIZATION, THE MECHANISM WAS PRESUMED TO BE INSUFFICIENT RADIAL FORCE OF THE PROSTHESIS TO ANCHOR AGAINST THE HEAVILY CALCIFIED LEFT CORONARY CUSP,¿ THE AUTHORS CONCLUDED. TO COMPLETE TAVR, THE MEDTRONIC CONFIDA GUIDEWIRE POSITION WAS MAINTAINED THROUGH THE EMBOLIZED VALVE, AND THEN A 23 MM NON-MEDTRONIC TRANSCATHETER VALVE (EDWARDS) WAS SUCCESSFULLY IMPLANTED. THEN, TO MITIGATE THE ¿SPONTANEOUS ROCKING¿ OF THE EMBOLIZED VALVE AND THE RISK OF AORTIC INJURY, A BARE METAL STENT APPROVED FOR THE TREATMENT OF AORTIC DISSECTION (COOK MEDICAL) WAS SELECTED AND DEPLOYED THROUGH THE EVOLUT FX, SECURING THE VALVE TO THE AORTIC WALL. THE PATIENT DID NOT EXPERIENCE ANY NEUROLOGICAL OR AORTIC INJURIES THROUGH THIRTY DAYS OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546951 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-29

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention