MAUDE Adverse Event Report: M.I. TECH CO., LTD. HANAROSTENT ESO TTS FC 20 DM 6CM 180

Model Number	ECBA-20-060-180
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this self-expanding metallic esophageal stent was used as off-label in the duodenum.The stent was sutured into the duodenum and when the patient came in for ct scan follow up, it was found that the stent had ripped away from the sutures and split in half.Additional information was received that additional surgery was done to remove both halves from the small bowel.Subsequent imaging confirmed the stent's removal.There were no further reports of patient harm.

• Brand Name: HANAROSTENT ESO TTS FC 20 DM 6CM 180
• Common Device Name: HANAROSTENT ESO TTS FC 20 DM 6CM 180
• Manufacturer (Section D): M.I. TECH CO., LTD.; 174 habuk 2-gil, jinwi-myeon; pyeongtaek, gyeonggi 17706 ; KS 17706
• MDR Report Key: 25737133
• Report Number: 2429304-2026-00090
• Device Sequence Number: 13365338
• Product Code: ESW
• UDI-Device Identifier: 08806367088406
• UDI-Public: 08806367088406
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026
• Report Date (Section F): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ECBA-20-060-180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/07/2026