BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 23715563 · Received December 4, 2025

    Report

    Report Number
    9617601-2025-03185
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    August 6, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HIROFUMI H, MASANORI Y, TOMOKI O, ET AL. DIFFERENCES IN CORONARY ALIGNMENT BETWEEN EVOLUT FX AND NAVITOR VALVES. CATHETER CARDIOVASC INTERV. 2025;106(4):2427-2438. DOI:10.1002/CCD.70062. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 THE DIFFERENCES IN CORONARY ALIGNMENT BETWEEN INTRA-ANNULAR (IA-SEV) AND SUPRA-ANNULAR SELF-EXPANDABLE VALVES (SA-SEV) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 402 PATIENTS WHO WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE VALVE TYPE USED DURING TAVR: IA-SEV (NON-MEDTRONIC NAVITOR, N = 152) OR SA-SEV (MEDTRONIC EVOLUT FX, N = 250). IN THE SA-SEV GROUP, THE FOLLOWING ADVERSE EVENTS WERE RECORDED: ISCHEMIC STROKE, BLEEDING (MAJOR OR LIFE-THREATENING), PACEMAKER IMPLANTATION, MODERATE TO SEVERE CORONARY OVERLAP (DISTANCE BETWEEN CORONARY OSTIA AND ADJACENT VALVE COMMISSURES), CORONARY OBSTRUCTION, ELEVATED MEAN GRADIENT, AORTIC REGURGITATION (MILD TO MODERATE), AND ACUTE KIDNEY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880224 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-23

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R