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 Perforation (2001)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the stent was not fully expanding due to the hard stenosis and the stenosis part was perforated.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 "the stent was not fully expanding due to the hard stenosis and the stenosis part was perforated.", it is considered that the stent was not fully expanded due to strong pressure of the patient's lesion, and it is assumed that the perforation occurred due to strong pressure of the stenosis and other element complexly, but it is hard to find out exact root cause since there is no further information such as photos etc, and the device was 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

On (b)(6) 2020: cxdt2206 was placed at transverse colon for the stenosis caused by colonic cancer.On (b)(6) 2020: it was found that the stent was not fully expanding due to the hard stenosis and the stenosis part was perforated.An emergency surgery was performed.Currently, the patient is recovered and stats eating without any problem.

• 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: 11074619
• MDR Text Key: 223719746
• Report Number: 3003902943-2020-00103
• 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: 11/30/2020

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: 10/15/2023
• Device Model Number: CXDT2206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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