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

Model Number CCT2012BP

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that ileus was found at the uncovered part, so additional treatment by endoscope was performed and the stent was migrated towards mouth side during the treatment.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, it is hard to exactly analysis because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.

Event Description

On (b)(6) 2020: the stent was placed.On (b)(6) 2020: ileus was found at the uncovered part, so additional treatment by endoscope was performed and the stent was migrated towards mouth side during the treatment.Currently, ileus is reduced by ileus tube and the migrated stent will be removed and additional stent will be placed next week.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that ileus was found at the uncovered part, so additional treatment by endoscope was performed and the stent was migrated towards mouth side during the treatment.Through the attached photo, it is confirmed that the stent is covered in foreign substances.As a result of analysis of returned device, the covered part of the stent was covered in foreign substances.The hole is observed in partial cover.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Migration can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.It is difficult to identify the exact root cause for stent migration because it is difficult to reconstruct the situation at the time of procedure.However, based on the description "ileus was found at the uncovered part, so additional treatment by endoscope was performed and the stent was migrated towards mouth side during the treatment.", it is considered that the ileus occurred due to the strong pressure of the patient's lesion in stent uncovered part, and then, it is assumed that the placed stent was migrated during additional treatment process (maybe ileus tube insertion).Also, after ileus is reduced, it is assumed that the cover hole occurred during removal the migrated stent.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent migration, 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

(b)(6) 2020: the stent was placed.(b)(6) 2020: ileus was found at the uncovered part, so additional treatment by endoscope was performed and the stent was migrated towards mouth side during the treatment.Currently, ileus is reduced by ileus tube and the migrated stent will be removed and additional stent will be placed next week.There were no patient complications as a result of this event.

• Brand Name: NITI-S ENTERAL COLONIC COVERED 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
• MDR Report Key: 10702843
• MDR Text Key: 212142884
• Report Number: 3003902943-2020-00085
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: CCT2012BP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization