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

Model Number CST2012B

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270); Migration (4003)

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

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that after 24 hours post procedure, colonic stent was excreted by the patient and upon evaluation of the stent it did not expand fully.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Our nitinol wire, the raw material of stent, is shape-memory alloy.Generally, if the stenosis of a patient's lesion is severe, the stent expansion may require some time.However, it is difficult to identify the exact root cause because it is difficult 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 "24 hours post procedure, colonic stent was excreted by the patient and upon evaluation of the stent it did not expand fully", it is assumed that the stent was not expanded temporarily due to the curve and strong pressure of patient's stenosis and other elements complexly.In addition, it is considered that before the stent fully expanded, it was excreted mixed with feces, and it is assumed that this affected the expansion of the stent even after it was excreted by the patient.Then, it is considered that the stent was excreted when the stent migrated due to the not fully expanded stent, condition of the patient's lesion, peristalsis and other elements complexly.Through the user manual by taewoong, it is stated that it is stated that "a stent may require up to 1 to 3 days to expand fully and balloon dilatation inside the stent can be performed if the physician deems necessary" and "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: inadequate expansion, 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.

Event Description

After 24 hours post procedure, colonic stent was excreted by the patient and upon evaluation of the stent it did not dilate fully.

• 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, 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: 12444821
• MDR Text Key: 270555679
• Report Number: 3003902943-2021-00033
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: RP
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: CST2012B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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