MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL COVERED STENT; PYLORIC & DUODENAL STENT

Model Number DCT2010BP

Device Problem Obstruction of Flow (2423)

Patient Problems Erosion (1750); Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that, 2 months after placing the stent, the reocclusion occurred, and it looks to be in-growth by seeing the images through the scope.Also, the stent had the other hole than the stenosis part.Through the attached photo, it is confirmed that two cover holes were observed and in/over growth has occurred on the stent body part, resulted in reocclusion.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Duodenum 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.However, based on the two cover holes near the patient's lesion and reocclusion, it is assumed that the cover was weaken due to the patient lesion's peristalses and foreign substance such as foods, body fluids and so on, resulted in occurring the hole and/or the damage.Also, tumor in/over growth has occurred on the damaging part, resulted in reocclusion.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, tumor overgrowth, stent occlusion.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) 2018: niti-s pyloric comvi stent was placed.On (b)(6) 2019: for the reocclusion of the stent placed in (b)(6) 2018 above, another niti-s pyloric comvistent was placed.Before the procedure, the physician expected that the covered part was pushed in due to the reocclusion, however, it looks to be in-growth by seeing the images through the scope.Over-growth in distal side was also considered but it was well extended.The stent placed first had the other hole than the stenosis part.It is expected that the durability of the cover got weak because the cell was larger with the cover itself against the stenosis.Another stent (niti-s) was used to finish the procedure.

• Brand Name: NITI-S PYLORIC & DUODENAL COVERED STENT
• Type of Device: PYLORIC & DUODENAL 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: 8553513
• MDR Text Key: 143259469
• Report Number: 3003902943-2019-00011
• Device Sequence Number: 1
• Product Code: MUM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: DCT2010BP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2018
• 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