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

Model Number EA2010FD

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

Due to a diagnosis, an esophageal stent placement procedure was performed.The procedure went normally; however, when the stent was removed, the anti-reflux system became stuck in the patient's esophagus.The physician placed a new stent so that the patient would not have problems swallowing food.

Manufacturer Narrative

It was reported that around 3 months after placing the stent and during removal, the anti-reflux system became stuck in the patient's esophagus.Based on the attached photo, it is confirmed that the inner stent was separated from the outer stent, and the outer stent was left in the esophagus.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Esophageal structure where stent implanted is the part with active peristalsis.Eaxxxxfd is manufactured as double type, and it is made of inner stent (full covered) and outer stent (uncovered).It is possible that the connection between inner stent and outer stent was weakened by food or body fluids.However, it is hard to identify the exact root cause since it is difficult to reconstruct the situation at the time of procedure, and the device was not returned.Based on the description, "when the stent was removed, the anti-reflux system became stuck in the patient's esophagus", it is considered that the connection part between inner and outer stent that was weakened due to food, body fluids, etc.Was detached due to excessive tensile force that was applied during removal.Then, it is considered the inner stent was removed, and a new stent was placed.It is stated on user's manual as follows."grasp the retrieval string and/or collapse the proximal end of the stent then carefully retrieve the stent.If the stent cannot be easily withdrawn, do not remove the stent." this suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• 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: 17359044
• MDR Text Key: 320166865
• Report Number: 3003902943-2023-00021
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EA2010FD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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