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

Model Number EST1812F

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 09/08/2023

Event Type  malfunction  

Event Description

Defective stent that doctor tried to employe.Second stent they used had no issues.When the nurse went to deploy the stent, the handle fell apart.

Manufacturer Narrative

It was reported that when the nurse went to deploy the stent, the handle fell apart.As a result of analysis of returned device, the outer sheath was detached and stent was loaded.There were curve and kinking on the stent loaded part of the outer sheath, and deployment was tried without pressure, but failed.It was manually deployed by hand, holding the tip, and pulled out by force.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 issues and passed all the inspections successfully.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 failure under no pressure, detached outer sheath, curve 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/curved sheath, 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.

• 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: 17937094
• MDR Text Key: 326389437
• Report Number: 3003902943-2023-00030
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221482
• 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: 09/21/2023

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: EST1812F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• 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