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

Model Number EST2012F

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that during the deployment, there was a lot of resistance with the rod.With the force used to deploy there was a pop sound at the handle and the stent would not deploy.As a result of analysis of returned device, the outer sheath was detached and stent was loaded.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.In the inner sheath, kinking was observed in the same position.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the deployment success under no pressure even though the strong resistance has occurred, detached outer sheath and kinking on the stent loaded part, 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, and causing kinking to occur.Therefore, it seems that strong resistance occurred and the outer sheath was detached in the end, resulting in deployment failure.This complaint is assumed that it was malfunction due to pressed by patient's lesion, there will be continued to monitor the same or similar customer complaints.

Event Description

A patient had a stent placement procedure with tts stent.During the deployment, there was a lot of resistance with the rod.With the force used to deploy there was a pop sound at the handle and the stent would not deploy.The device was withdrawn from the patient and another of the same was used to continue the procedure.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: 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: 15024776
• MDR Text Key: 304806792
• Report Number: 3003902943-2022-00015
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K123205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: EST2012F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1