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

Model Number DXDT2212

Device Problems Break (1069); Fracture (1260); Migration (4003)

Patient Problem Erosion (1750)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that around 14 months of stent placement, the stent was found fractured, and the fractured part of the stent was migrated into the stomach.In-growth was found in the remaining part of the stent.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 could be pressed and stent in-growth could occur by state of patient's lesion.In addition, fracture 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.Stent can be frequently pressured due to patient's lesion status, and fracture can be possible.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 difficult to identify the exact root cause because the device was not returned, information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "in-growth was found inside of the remaining part of the stent", it is assumed in-growth occurred on the stent as the stent was pressed due to the condition of patient's lesion, pressure, and other factors.This device is an uncovered device, and it is natural for in-growth to occur.In addition, based on the description "stent was found being fractured at about half of stent" it is assumed that fracture has occurred due to the complex influence of the stent in-growth, the patient lesion's pressure, peristalses of organs and other factors.Then, based on the description "fractured part of the stent was in the stomach", it is supposed that the migration of the fractured part of the stent had occurred.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 the device was not returned, information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure.However, it is supposed that migration has occurred due to the complex influence of the patient's lesion status, peristalsis, foreign substances and other factors.Then, it is considered the migrated part was removed.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: tumor in-growth, stent fracture and stent migration".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) 2020: dxdt2212 was placed from the second part of duodenum, partially sticking out into the stomach.On (b)(6) 2021: as the patient recently complained of a feeling of jam, gastroscope was used to check, and then the stent was found being fractured at about half of stent and the fractured part of the stent was in the stomach.The fractured part was removed by forceps.In-growth was found inside of the remaining part of the stent, so dxdt2210 was additionally placed.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• MDR Report Key: 12741842
• MDR Text Key: 281855504
• Report Number: 3003902943-2021-00041
• Device Sequence Number: 1
• Product Code: MUM
• 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
• Report Date: 10/07/2021

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: 07/16/2023
• Device Model Number: DXDT2212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization