MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT

Model Number	EST2015F
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Stent did not deploy/open after being unlocked and pulled back.
Additional Manufacturer Narrative
It was reported that the stent did not deploy.As a result of analysis of returned device, the outer sheath was detached and stent was loaded.There were no curve and kinking on the stent loaded part of the outer sheath, and deployment was tried without pressure, and very strong resistance occurred, but it was gradually deployed, resulting in deployment success.In the inner sheath, but notable kinking was not observed.Resistance can be felt due to pressure generated by patient's lesion during deployment.It can cause deployment failure if deployment is tried by force in this situation since outer sheath can be stretched and detached.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.Based on the deployment success under no pressure even though the strong resistance has occurred and detached outer sheath, it is considered that delivery system was pressured due to patient's lesion during the procedure and deployment was tried in that situation.It was hard to deploy due to pressure, in which concentrated the force causing strong resistance and the outer sheath was detached in the end, resulting in deployment failure.In addition, it is supposed that strong resistance occurred under no pressure because delivery system was deformed during procedure.This complaint is assumed that it was a malfunction of the device due to the pressure of the patient's lesion, there will be continued monitoring of the same or similar customer complaints.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Common Device Name: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 22503344
• Report Number: 3003902943-2025-00016
• Device Sequence Number: 9303755
• Product Code: ESW
• UDI-Device Identifier: 08809744975597
• UDI-Public: 08809744975597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EST2015F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown