BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT ESOPHAGUS TTS (CCC)

    MDR report key: 24320318 · Received February 12, 2026

    Report

    Report Number
    3008146331-2026-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    September 9, 2025
    Report Date
    February 12, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE DISTRIBUTOR ALSO SUBMITTED A REPORT (REFERENCE NO.:2429304-2025-00292-00). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT AS A TRANSPYLORIC STENT. 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. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 0

    A TRANSPYLORIC 20 MM X 15 CM HANARO FULLY COVERED METAL STENT WAS DEPLOYED AND SUTURED INTO PLACE. PATIENT WENT TO OUTSIDE FACILITY FOR ABDOMINAL PAIN AND CT IMAGING REVEALED A FRAGMENT OFTHE STENT HAD BROKEN OFF AND MIGRATED INTO THE SMALL BOWEL, LIKELY CAUSING SMALL BOWEL OBSTRUCTION.PATIENT ISSCHEDULED FOR A DOUBLE BALLOON ENTEROSTOMY TO RETRIEVE THE BROKEN STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382011 HANAROSTENT ESOPHAGUS TTS (CCC) HANAROSTENT ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-150-230 24101229

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention