BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT ESO TTS FC 20 DM 10CM 230

    MDR report key: 21887185 · Received April 22, 2025

    Report

    Report Number
    3008146331-2025-00001
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    May 23, 2025
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE HOSPITAL ALSO SUBMITTED A REPORT UNDER MEDWATCH REFERENCE NO: (B)(4). THE PRODUCT WAS NOT RETURNED, SO NO PHYSICAL EVALUATION WAS PERFORMED. BASED ON THE DESCRIPTION, A STENT FRACTURE OCCURRED POST-PLACEMENT WITH SUBSEQUENT FRAGMENT MIGRATION AND A CECAL PERFORATION. CAUSALITY BETWEEN THE DEVICE AND THE PERFORATION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE HOSPITAL ALSO SUBMITTED A REPORT UNDER MEDWATCH REFERENCE NO: 2429304-2025-00042-00. THE PRODUCT WAS NOT RETURNED, SO NO PHYSICAL EVALUATION WAS PERFORMED. BASED ON THE DESCRIPTION, A STENT FRACTURE OCCURRED POST-PLACEMENT WITH SUBSEQUENT FRAGMENT MIGRATION AND A CECAL PERFORATION. CAUSALITY BETWEEN THE DEVICE AND THE PERFORATION HAS NOT BEEN CONFIRMED. FOLLOW-UP: THE CASE ANALYSIS REPORT HAS BEEN ATTACHED TO PROVIDE ADDITIONAL FINDINGS RELATED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ESOPHAGEAL STENT FRACTURED AFTER BEING PLACED INSIDE THE PATIENT, AND THE BROKEN PIECE MIGRATED TO THE PATIENT'S CECUM. THE BROKEN PIECE WAS PLANNED TO BE REMOVED VIA COLONOSCOPY AFTER IT WAS DISCOVERED ON COMPUTED TOMOGRAPHY (CT) IMAGING, BUT IT WAS FOUND THE BROKEN PIECE HAD PERFORATED THE CECUM, WITH PERITONEAL SIGNS. THE PATIENT WAS TAKEN TO EMERGENCY SURGERY AS THE CECUM NEEDED TO BE RESECTED, AND THE BROKEN PIECE WAS RETRIEVED SURGICALLY FROM THE PERFORATION SITE. THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE PATIENT WAS REPORTED TO BE STABLE NOW POST SURGERY AND RECOVERING, BUT NEEDED TO GET A FEEDING TUBE FOR NUTRITION AS HE DID NOT WANT ANOTHER STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ESOPHAGEAL STENT FRACTURED AFTER BEING PLACED INSIDE THE PATIENT, AND THE BROKEN PIECE MIGRATED TO THE PATIENT'S CECUM. THE BROKEN PIECE WAS PLANNED TO BE REMOVED VIA COLONOSCOPY AFTER IT WAS DISCOVERED ON COMPUTED TOMOGRAPHY (CT) IMAGING, BUT IT WAS FOUND THE BROKEN PIECE HAD PERFORATED THE CECUM, WITH PERITONEAL SIGNS. THE PATIENT WAS TAKEN TO EMERGENCY SURGERY AS THE CECUM NEEDED TO BE RESECTED, AND THE BROKEN PIECE WAS RETRIEVED SURGICALLY FROM THE PERFORATION SITE. THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE PATIENT WAS REPORTED TO BE STABLE NOW POST SURGERY AND RECOVERING, BUT NEEDED TO GET A FEEDING TUBE FOR NUTRITION AS HE DID NOT WANT ANOTHER STENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674172 HANAROSTENT ESO TTS FC 20 DM 10CM 230 HANAROSTENT ESO TTS FC 20 DM 10CM 230 ESW M.I.TECH CO., LTD. ECBA-20-100-230 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H