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

Model Number CDT2206

Device Problem Occlusion Within Device (1423)

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

Event Date 11/17/2013

Event Type  Death  

Event Description

On (b)(6) 2013 stent was placed.On (b)(6) 2013 pt claimed a stomachache and underwent a colonoscopy.No migration, no in-growth was admitted at this point.On (b)(6) 2013 ct scan revealed that no stent remained in pt's body.It was assumed that stent was removed by bowel movement.On (b)(6) 2013 another follow up colonoscopy admitted obstruction was released.Physician concluded that stent was removed because of the obstruction released due to anticancer (ts-1) used effectively.On (b)(6) 2013 this pt died from subarachnoid hemorrhage.

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.It is hard to find out exact root cause for this complaint, because it is difficult to reconstruct the situation at that time in the lab and limited info.On our user manual, it is mentioned that chemoradiation therapy or radiotherapy alone may lead to tumor shrinkage and subsequent stent migration.The pt died from subarachnoid hemorrhage, bleeding into the subarachnoid space.It is supposed that there is no relation to use of niti-s stent and pt's death.And there are no cses of subarachnoid hemorrhage in clinical evaluation report.We recognize the risk of stent migration, and have been conduced risk management.We will monitor this complaint occurrence for same model.This report is retrospective report due to fda foreign inspection warning letter.The suspected device is not registered to united states fda and it has been shipped into the united states.

• Brand Name: NITI-S ENTERAL 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: 4872092
• MDR Text Key: 6060086
• Report Number: 3003902943-2015-00039
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2016
• Device Model Number: CDT2206
• 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: 87 YR