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

Model Number EST1806F

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 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stent would not deploy.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, it is hard to exactly analyze because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.

Event Description

During stent placement, the stent would not deploy.They used a different stent to finish the case successfully.

Manufacturer Narrative

It was reported that 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 it deployed well.In the inner sheath, notable kinking was not observed.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Resistance can be felt due to pressure generated by patient's lesion during deployment.Outer sheath can be stretched and detached so it can cause deployment failure if deployment was tried by force in this situation.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, 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 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 Description

During stent placement, the stent would not deploy.They used a different stent to finish the case successfully.

• 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: 15154333
• MDR Text Key: 304710771
• Report Number: 3003902943-2022-00021
• 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,Followup
• Report Date: 07/12/2022

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 Model Number: EST1806F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• 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