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); Migration (4003)

Patient Problem Nausea (1970)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that after 3 months of stent placement, the stent was migrated, and was collapsed during removal.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.In addition, fracture can occur in other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Duodenum structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture be possible.It is difficult to identify the exact root cause because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "migrated part of stent moved much more to the anal side than it used to be on 2023/5/18.The physician tried to remove the stent in the small intestine by forceps through the scope, but the stent collapsed where was held by the forceps.", it is assumed the stent was migrated due to severe pressure at the patient's lesion, peristalsis of organs, foreign substances such as food and other factors complexly.It is assumed this caused the patient to have nausea.Then it is assumed that the migrated stent was fractured due to the combination of continuous stress on the stent from the pressure generated from the patient's lesion, excessive tensile force applied to the stent during removal, and other factors complexly and the fractured part of the stent 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: stent migration, stent fracture".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) 2021: another stent was placed in the third part of duodenum for pancreatic cancer.(b)(6) 2023 : dct2012bp was placed for the in-growth of stent above.(b)(6) 2023: it was found that a half of dct2012bp was migrated into the small intestine during the periodic inspection.The patient did not have any symptom at that time, so it was determined to monitor without any treatment.(b)(6) 2023 the patient complained of nausea, so the patient investigation was done and revealed that the migrated part of stent moved much more to the anal side than it used to be on (b)(6) 2023.The physician tried to remove the stent in the small intestine by forceps through the scope, but the stent collapsed where was held by the forceps.The stent was finally removed from the small intestine but another half of dct2012bp is remaining in the uncovered stent.No additional treatment is planned, but if it is done later, it would be surgical bypass.The patient is receiving chemotherapy.There is no other complication.

• 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, gyeonggi-do 10022
• MDR Report Key: 17264371
• MDR Text Key: 318545292
• Report Number: 3003902943-2023-00019
• 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: 06/12/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DCT2012BP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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