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

Model Number CXDT2208

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that it was found that the distal part (1cm) of the stent was deployed in the abdominal cavity.Also, the part of large intestine with stenosis (sigmoid to rectum) was removed together with the stent.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Perforation can be occurred by other 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 description, it is considered that the stent was not expanded properly due to pressure of patient's lesion, and then it is assumed that the perforation occurred during the stent expansion using the balloon, but it is hard to find out exact root cause since there is no further information such as photo, and the device was removed but not returned, and it is difficult to reconstruct the situation at the time of procedure.Through the user manual by taewoong, it is stated that "contradiction, the niti-s & comvi enteral colonic stent is contraindicated for, but not limited to; suspected or impending perforation.", and also, "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: 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

After the stent placement (cxdt2208), the stent was found not expanding at all (partially for 1cm at distal edge).It was not unclear whether it was placed at the intended position under contrast radiography because intestinal tract was seen overlapping each other.In order to check, the stent was expanded by balloon for 1cm and nasal scope was inserted to observe.Then, it was found that the distal part (1cm) of the stent was deployed in the abdominal cavity.After that, it was confirmed under ct image and surgical treatment is planned afterwards.The information will be updated with the patient's condition after the surgical treatment.[11.09 updated information]: the part of large intestine with stenosis (sigmoid to rectum) was removed together with the stent.The patient has stoma now.Perforation was still within the tumor, so nothing was leaking into the abdominal cavity.

• 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: 10814947
• MDR Text Key: 215573028
• Report Number: 3003902943-2020-00096
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: CXDT2208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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