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

Model Number DCT2012BP

Device Problems Break (1069); Fracture (1260); Material Perforation (2205)

Patient Problems Erosion (1750); Vomiting (2144); Stenosis (2263)

Event Date 12/05/2022

Event Type  Injury  

Event Description

(b)(6) 2022: dct2012bp was placed in stent-in-stent method.(b)(6) 2022: it was reported that the covered stent was found being damaged and the cover was also damaged under endoscopy, causing re-stenosis there.Further information will be provided when it is available.

Manufacturer Narrative

It was reported that 2 months after stent placement, the stent was found damaged and re-stenosis occurred.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 analyze because not enough information was provided.Investigation will be conducted once further information is provided and we will send follow-up report accordingly.

Manufacturer Narrative

It was reported that 2 months after stent placement, the stent was found damaged, and in-growth and re-stenosis occurred.Based on the attached photo, it is confirmed that the distal part of the stent was fractured, the cover was damaged and in-growth had occurred.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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.Duodenum structure where stent was implanted is curvy.It is possible that the stent could be pressed and stent in/over-growth could occur by state of 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.In addition, inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.It is confirmed from the inspection result certificate that it passed successfully.However, based on the damaged stent cover in the attached photo, there is a possibility that cover damage has occurred due to the fractured stent, patient lesion's pressure, peristalses of organs, foreign materials such as food and other factors complexly.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.After that event, it is considered a stomach tube catheter was used, but failed to improve the patient status, therefore a stent was placed.In addition, after the stent fracture, it is assumed tissue was grown inside the stent and re-stenosis occurred when the stent was pressed due to the progression of the disease and strong pressure at the patient's stenosis.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) 2022: dct2012bp was placed in stent-in-stent method.(b)(6)2022: the patient complained of vomiting and there were a lot of leftovers, having re-stenosis.The covered stent was found being damaged and the cover was also damaged under endoscopy.Stomach tube catheter was placed, and it was determined to monitor how it would go.(b)(6) 2023: another stent was placed because the stomach tube catheter did not improve.The cover part and flare part of the stent were found being fractured, having in-growth on the cover (as much as not being able to see the cover).

• 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, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 16092688
• MDR Text Key: 306593242
• Report Number: 3003902943-2023-00001
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCT2012BP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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