BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23152453 · Received September 26, 2025

    Report

    Report Number
    3008146331-2025-00004
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 29, 2025
    Report Date
    February 13, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS INTENDED TO CORRECT THE CODING TERMS THAT WERE EITHER INCORRECTLY ENTERED OR OMITTED IN THE PREVIOUS REPORT. THE HOSPITAL ALSO SUBMITTED A REPORT ((B)(4), REFERENCE NO:(B)(4)). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT IN A DUODENAL PROCEDURE. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE HOSPITAL ALSO SUBMITTED A REPORT (EMDR-(B)(4), REFERENCE NO:2429304-2025-00251-00). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT IN A DUODENAL PROCEDURE. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC STENT REMOVAL FOR A DUODENAL STRICTURE, THE SUSPECT DEVICE BROKE IN HALF. THE PIECES WERE RETRIEVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC STENT REMOVAL FOR A DUODENAL STRICTURE, THE SUSPECT DEVICE BROKE IN HALF. THE PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304020 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-100-230 24101248

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention