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

Model Number DXDT2208

Device Problems Break (1069); Fracture (1260)

Patient Problem Feeding Problem (1850)

Event Date 11/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022: dxdt2206 was placed at the pylorus coming into the stomach for the stomach cancer.(b)(6) 2022: the patient complained of not being able to eat, so the patient was examined.Then, the stent was found being fractured where was coming into the stomach, and the fractured stent (2cm) was in the stomach.It was picked it into the over tube of double-balloon endoscopy and removed together.Another stent was placed at the pylorus, with the cover in the stomach side.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that about 3 months after stent placement, the stent was found being fractured.Based on the attached photo, it is confirmed that part of the stent was fractured, and the fractured stent was covered in foreign materials.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.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 and it is difficult to reconstruct the situation at the time of procedure.However, based on the foreign materials on the fractured stent in the attached photo, it is assumed that fracture has occurred due to the patient lesion's pressure, peristalses of organs, foreign materials such as food and other factors complexly.It is assumed it caused the patient to be unable to eat, and the fractured 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: 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.

• 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
• 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: 15921448
• MDR Text Key: 304873135
• Report Number: 3003902943-2022-00037
• 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: 11/14/2022

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: DXDT2208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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