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

Model Number EK2420FNT2

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation (2001)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that during the introduction of the stent the distal end of the delivery got stuck in the gastric stenosis and in an attempt to push it further, bending occurred and a full thickness injury of the middle of the esophagus occurred.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is difficult to identify the exact root cause because the device was not returned, information such as photos were not provided and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "during the introduction of the stent the distal end of the delivery got stuck in the gastric stenosis and in an attempt to push it further, bending occurred and a full thickness injury of the middle of the esophagus occurred", it is assumed that insertion of the delivery system was difficult due to the strong pressure of the stenosis, condition of the patient's lesion and other factors.Then, it is assumed that kinking of the delivery system occurred, then full thickness injury of the middle of the esophagus occurred during the additional attempt for insertion of the delivery system.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: perforation" this suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

During the introduction of the stent the distal end of the delivery got stuck in the gastric stenosis and in an attempt to push it further, bending at right angles in the proximal part, area of least resistance that caused (after implantation of stent), an full thickness injury of the middle of the esophagus.

• 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, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 15049257
• MDR Text Key: 296140068
• Report Number: 3003902943-2022-00017
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EK2420FNT2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male