BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EVOLUT FX VALVE

    MDR report key: 23405369 · Received October 28, 2025

    Report

    Report Number
    9617601-2025-02277
    Event Type
    Death
    Date Received
    October 28, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TVT REGISTRY EXEMPTION NUMBER: E2014038 QUARTERLY REPORTING PERIOD: Q3 2025 TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 4 UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED PATIENT DEMOGRAPHICS DETAILS AND LIMITED DETAILS WERE PROVIDED REGARDING THE ADVERSE EVENTS AND OUTCOMES. THE LISTED EVENT DATE IS THE DATE THE INFORMATION WAS RECEIVED BY MEDTRONIC. THE PATIENT INFORMATION INCLUDED IN SECTION A. IS AN AVERAGE OF THE DATA PROVIDED FOR THE EVENTS. A PRODUCT ANALYSIS WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT WAS RETURNED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE VIEWS OR OPINIONS PRESENTED HERE DO NOT REPRESENT THOSE OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION, THE SOCIETY OF THORACIC SURGEONS, OR THE STS/ACC TVT REGISTRY. THE INDUSTRY DATA FILE UPON WHICH THE ANALYSIS WAS PERFORMED IS A SUBSET OF THE FULL STS/ACC TVT REGISTRY DATA SUBMISSIONS. 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

    THE TYPE OF DEATHS BEING REPORTED ARE NEUROLOGIC. THE AVERAGE TIME TO EVENT WAS ONE HUNDRED TWENTY-ONE DAYS FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT AGES IN THIS REPORT RANGE FROM 70 TO 90 AND OVER. THERE WERE 3 MALES AND 1 FEMALE. THE CAUSE OF DEATH PROVIDED IS LIMITED IN NATURE AS IT IS PROVIDED VIA A THIRD-PARTY DATABASE. MEDTRONIC RECEIVED INFORMATION REGARDING PATIENT/DEVICE EVENTS VIA A THIRD-PARTY POST-IMPLANT DEVICE REGISTRY (THE SOCIETY OF THORACIC SURGEONS/AMERICAN COLLEGE OF CARDIOLOGY TRANSCATHETER VALVE THERAPY REGISTRY). THE INFORMATION IN THIS REPORT WAS PROVIDED TO MEDTRONIC IN A DE-IDENTIFIED FORMAT AND HAS BEEN ORGANIZED INTO SUMMARIES OF OBSERVATIONS RELATED TO PATIENT DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029148 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV COREVALVE EVOLUT FX & FX SYSTEM (23MM, 26MM, 29MM & 34MM)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Death