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

Model Number CCT2010BP

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Perforation (2001)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported the stent was placed, but the stenosis at the site was severe as the scope could not go through.Around 1 week after stent placement, the stent was found being migrated for 2 or 3 cm towards the anal side under ct, and the flare part of the stent on the distal side was narrowed due to the migration of the stent and stenosis, causing the stool to be blocked.The stent edge on the proximal side caused perforation and emergency surgery was performed to remove the part of intestine with the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Migration can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.It is difficult to identify the exact root cause because the device was not returned, information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure.However, based on the procedure information "the stenosis was severe one as much as the scope cannot go through." it is supposed stent migration occurred due the severe pressure at the patient's lesion, peristalsis of organs and other factors.It would seem that after that, the flare part of the stent on the distal side was narrowed due to the severe pressure at the stenosis causing stool to be blocked.In addition, perforation can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Based on the procedure information "the stent edge on the proximal side caused perforation and emergency surgery was performed to remove the part of intestine with the stent", it is supposed perforation occurred due to the complex combination of migration of the stent and pressure at the patient's lesion and other factors, but it is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.It would seem that after that, emergency surgery was performed to remove the part of intestine with the stent.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi enteral colonic stent may include, but are not limited to: stent migration and intestinal 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

(b)(6) 2021: the stent was placed at the center of 3 cm stenosis in descending colon purposing bts.The stenosis was severe one as much as the scope cannot go through.(b)(6) 2021: the stent was found being migrated for 2 or 3 cm towards the anal side under ct.Due to the migration, the flare part of the stent (mouth side) was pressured by the stenosis and narrowed, causing the stool was blocked again.In addition, the uncovered part (stent edge) of the stent (anal side) caused perforation and emergency surgery was performed to remove the part of intestine with the stent.

• Brand Name: NITI-S ENTERAL COLONIC COVERED STENT
• Type of Device: COLONIC 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: 11376924
• MDR Text Key: 240100837
• Report Number: 3003902943-2021-00006
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: CCT2010BP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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
• Patient Outcome(s): Hospitalization