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

Model Number CDT2212

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

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

Event Date 03/19/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, due to descending colon obstruction, the patient was implanted in the gastroscopy room of (b)(6) with niti-s enteral colonic uncovered stent, cdt2212.After the stent was released, feces gushed out and blocked the endoscopic field of vision.After rinsing, the stent was found to have shifted inward without support at the focal site, and then the second niti-s enteral colonic uncovered stent was implanted.

Manufacturer Narrative

It was reported that after stent was released, feces gushed out and the stent was found to have shifted from the focal site.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, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "after the stent was released, feces gushed out and blocked the endoscopic field of vision.After rinsing, the stent was found to have shifted inward without support at the focal site", it is assumed the stent was migrated due to progression of the patient's disease and patient's condition, feces during the procedure 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".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 ENTERAL COLONIC UNCOVERED 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: 16828668
• MDR Text Key: 314297078
• Report Number: 3003902943-2023-00012
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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