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

Model Number	EST2212F
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
Additional Manufacturer Narrative
It was reported that the stent did not deploy/open after being unlocked and pulled back.As a result of analysis of returned device, the outer sheath was not detached and stent was loaded.The pusher was pulled to the proximal side.There was 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.The tip was inserted into the sheath and the stent was pulled to the proximal side from the normal loading position.In the inner sheath, curve was observed, but notable kinking was not.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, curve and kinking on the stent loaded part, it is considered that delivery system was pressured due to patient's lesion during procedure and deployment was tried in that situation.It was hard to deploy due to pressure/curved sheath, in which concentrated the force, and causing kinking to occur.Therefore, it seems that strong resistance occurred, resulting in deployment failure.In addition, based on the tip being inserted into the sheath and the pusher and stent being pulled to the proximal side, it is considered it occurred during the repeated pushing and pulling the pusher to deploy it.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.
Event or Problem Description
Stent did not deploy/open after being unlocked and pulled back.

• 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: 21870553
• Report Number: 3003902943-2025-00011
• Device Sequence Number: 7900009
• Product Code: ESW
• UDI-Device Identifier: 08809744975634
• UDI-Public: 08809744975634
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221482
• 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): 04/10/2025

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: EST2212F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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