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

Model Number CDT2012

Device Problem Obstruction of Flow (2423)

Patient Problems Erosion (1750); Obstruction/Occlusion (2422)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that, only 4 days after the deployment, the stent obstructed due to the tumor ingrowth.Tumor ingrowth was not clearly observed, but, it was observed that the stent was obstructed due to the pressure.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Colon structure where stent was implanted is curvy.It is possible that the stent can be pressed by patient's lesion.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the root cause because the suspected device was not returned and the patient's information is insufficient.However, based on the description, which was written that "the patient's disease is colon tumor", and "four days after the stent deployment, the stent was obstructed due to the tumor ingrowth, but the second stent was placed three days later.", it is assumed that the stent was partially depressed due to the pressure by patient's serious tumor stenosis.It seems that in this state, the tumor was ingrowth, resulted in stent obstruction.It is stated on user manual as follows.6.Potential complications: potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: tumor ingrowth.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

The physician deployed the cdt2012 into the patient successfully on (b)(6), however he found the stent obstructed due to the tumor ingrowth on (b)(6).As this physician never experienced the stent obstructed only 4 days after the deployment.He deployed the second stent on (b)(6) 2019.

• 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: 8346798
• MDR Text Key: 136485553
• Report Number: 3003902943-2019-00004
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: CDT2012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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