BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 23026141 · Received September 11, 2025

    Report

    Report Number
    9617601-2025-01402
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 11, 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: MASANORI YAMAMOTO, ET AL. INTRA- VERSUS SUPRA-ANNULAR SELF-EXPANDING TRANSCATHETER HEART VALVES IN SMALL AORTIC ANNULI. EUROINTERVENTION. 2025;21: E749-E757. PUBLISHED ONLINE E-EDITION JULY 2025. DOI: 10 4244/EU-D-24-00966 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 INTRA-ANNULAR SELF-EXPANDING VALVES (IA-SEVS) VERSUS SUPRA-ANNULAR (SA)-SEVS IN TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PATIENTS WITH SMALL AORTIC ANNULI. THE STUDY POPULATION CONSISTED OF 919 PATIENTS WHO UNDERWENT TAVI WITH EITHER A NON-MEDTRONIC IA-SEV (NAVITOR, N = 518) OR A MEDTRONIC SA-SEV (EVOLUT FX, N = 401). IN THE SA-SEV GROUP, THE FOLLOWING ADVERSE OUTCOMES OCCURRED: CONVERSION TO OPEN SURGERY, NEED FOR SECOND VALVE IMPLANT, CORONARY OCCLUSION, ISCHEMIC STROKE, NEED FOR PERMANENT PACEMAKER IMPLANT, MAJOR VASCULAR COMPLICATION, BLEEDING (MAJOR OR LIFE-THREATENING), HIGH MEAN GRADIENT (= 20 MMHG), PARAVALVULAR LEAK (TRACE TO SEVERE), PROSTHESIS-PATIENT MISMATCH, AND ACUTE KIDNEY INJURY. TWO IN-HOSPITAL DEATHS WERE ALSO OBSERVED. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN A MEDTRONIC DEVICE AND THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2674879 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