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

Model Number CDT2210

Device Problem Occlusion Within Device (1423)

Patient Problems Abdominal Pain (1685); Death (1802)

Event Date 07/17/2013

Event Type  Death  

Event Description

On (b)(6) 2013 stent placement.Stent was placed successfully.On (b)(6) 2013 stent occlusion due to tumor in-growth through stent was admitted.On (b)(6) 2013 pt died from colon cancer.This pt was to receive chemotherapy after stent placement; however, general status of the pt was very bad and such treatment was not taken.

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.Since it is difficult to reconstruct the situation at that time in the lab and limited into, it is hard to find out exact root cause for this complaint.We recognize the risk of stent occlusion, and have been conducted risk management control.On our user manual, it is mentioned that stent occlusion.We will monitor this complaint occurrence for same model.Medical option: physician denies that the device attributed to the pt death.This report is retrospective report due to fda foreign inspection warning letter.The suspected device is not register to united states fda and it had not been shipped into the united states.

• Brand Name: NITI-S ENTERNAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; goyang-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; goyang-si, gyeonggi-do ; 19960641
• MDR Report Key: 4872091
• MDR Text Key: 21835297
• Report Number: 3003902943-2015-00037
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 08/06/2013

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2016
• Device Model Number: CDT2210
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2013
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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): Death
• Patient Age: 83 YR