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

Model Number DXDT2210

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

Patient Problem Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

It was reported that dxdt2210 niti-s stent and another stent were placed for the duodenal obstruction.The stents were found being migrated into the upper side of jejunum, and were removed.It is hard to review suspected device's dhr, because the serial no.Was not checked.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 because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "niti-s stent (dxdt2210) and another stent (dxdt2212) was placed for the obstruction.After that, the patient continuously vomited, therefore, ct was performed and the stents were found being migrated into the upper side of jejunum." it is assumed stent migration of the stents into the upper side of jejunum occurred due to severe pressure at the patient's lesion, peristalsis of organs, foreign substances such as food and other factors complexly, and it is considered this caused the patient to continuously vomit.After that, it is considered the 2 stents were 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".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

Duodenal obstruction occurred after 2 months of pancreatic cancer removal.Niti-s stent (dxdt2210) and another stent (dxdt2212) were placed for the obstruction.After that, the patient continuously vomited, therefore, ct was performed and the stents were found being migrated into the upper side of jejunum.The migrated stents were removed to finish the procedure.This case is linked to a previous reported case (mdr registration number: 3003902943-2021-00026).This stent migration case is being reported was used with a stent that was previously reported for another case.

• 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, 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: 12208227
• MDR Text Key: 262943254
• Report Number: 3003902943-2021-00027
• 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
• Report Date: 06/23/2021

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 Model Number: DXDT2210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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