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

Model Number CDT1808

Device Problem Migration (4003)

Patient Problems Pain (1994); Perforation (2001)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that 1 hour after stent placement, patient complained of pain and stent was found migrated and perforated in gastro intestinal tract.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.In addition, perforation can occur due to other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.In addition, 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, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "stent placement would not be stable because the tumor was not coming into git", it is assumed the stent was migrated and perforated at the gastro intestinal tract due to progression of the patient's disease and patient's condition, peristalsis of organs and other factors complexly.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: stent migration, 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

This patient is not given chemotherapy and the stent was not all circumstance stenosis.The patient complained of pain after approx.1 hour of stent placement, and then stent migration and perforation in git.It is unknown if the perforation was caused by the stent.The perforation may be at the tumor and the stent was not fractured in this event.The physician understood that the stent placement would not be stable because the tumor was not coming into git.There were no patient complications as a result of this event.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC 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: byeoungcheol lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• MDR Report Key: 16850983
• MDR Text Key: 314391503
• Report Number: 3003902943-2023-00015
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: CDT1808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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