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

Model Number CDT1808

Device Problem Insufficient Information (3190)

Patient Problems Ulcer (2274); Pressure Sores (2326)

Event Date 02/17/2015

Event Type  Injury  

Event Description

On (b)(6) 2015: (b)(4) was implanted to a patient with sigmoid colon cancer stage iv.On (b)(6) 2015: an operation was performed as scheduled.During the operation, doctor found the stent somewhat digs deep into mucosal tissue at three points on the stent distal side (not proximal).One of the three points resulted in a ulcer formation.Also, abscess was found in the mesentery.It was not a complete perforation.This site of lesion was removed (stent also removed) during this operation.The patient is already recovered and out of the hospital due to the above reason.As a result of pathological examination (at hospital); no diverticulum found; blood vessel just below the site of lesion may have been thickened and blocked the flow which seems to be most attributable to ulcer formation.

Manufacturer Narrative

We evaluate all potential complications based on clinical evaluation report.Ulcer is one of cases found in the clinical evaluation and thus the risk for the complication is described and reviewed in our risk management report.According to risk management report, the ulcer is sorted into incredible level, and also it was reported for the first time since it was released.It was confirmed by reviewing the device history record of the device that there was nothing significant, that it was manufactured normally.There is no patient info, and since it is difficult to reconstruct at that time in the lab and limited info, it is hard to find out exact root cause for this complaint.But we will continue to monitor for potential complications, if reoccur.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si; gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeon-ro, wolgot-myeon, gimpo-si; gyeonggi-do ; 19960641
• MDR Report Key: 4726675
• MDR Text Key: 5669164
• Report Number: 3003902943-2015-00018
• 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: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2017
• Device Model Number: CDT1808
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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