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

Model Number CXDT2206

Device Problem Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that 10 hours after stent placement, abdominal expansion was confirmed and the stent on the oral side of the intestine was also confirmed being expanded so much in ct image.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, but it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the description, which was written that "the stent on the oral side of the intestine was also confirmed being expanded so much", "the reason for the abdominal expansion could be ileus.", "the stent was not fully expanded after 10 hours" and "the stenosis was about 2cm", it is assumed that the stent on the oral side assumed to be out of the stenosis part, was gradually expanded in length of time, but the stent on the lesion part was not expanded due to the patient lesion's strong pressure.Also, it is considered that stent was not fully expanded due to the patient lesion's pressure even though the time is gone.However, it is difficult to exactly analysis since the photo was not provided to us, and it is hard to reconstruct the situation at the time of procedure.It is stated on user manual as follows.Potential complications: stent occlusion.Procedure: after stent deployment.Balloon dilatation inside the stent can be performed on demand.Perform routine post implant procedures, a stent may require up to 1 to 3 days to expand fully.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 was pal (palliative therapy) case and the patient moved so hard during procedure.The stenosis was about 2cm on transverse colon closer to splenic flexure.The scope position could not be stable but cxdt2206 was placed.After 10 hours in the morning, abdominal expansion was confirmed and the stent on the oral side of the intestine was also confirmed being expanded so much in ct image.Therefore, an emergency surgery was performed.Updated on 2019.11.14 and then the stent placement part of the transverse colon closer to splenic flexure was excised.Updated on 2019.11.21 the reason for the abdominal expansion could be ileus.The stent was not fully expanded after 10 hours.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: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 9380573
• MDR Text Key: 185802031
• Report Number: 3003902943-2019-00043
• 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: 11/11/2019

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 Expiration Date: 07/15/2022
• Device Model Number: CXDT2206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR