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)

Patient Problem Stenosis (2263)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

According to the report, poor passage of food was confirmed and the stent was found being fractured at the center by computed tomography.Through the attached photo, it was observed that the stent was fractured.Fracture can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.The pylorus where stent was implanted is curvy and especially, has a lot of momentum.Stent can be frequently pressured due to patient's lesion status and fracture be possible.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the doctor's comment, it is considered that the placing stent was pushed by the scope, which caused the stent cell to overlap and not expand well and, the tumor infiltrated from the pushed part of the stent(ingrowth) and a force was applied there, therefore, the fracture has occurred.However, it is hard to identify the exact root cause since the device was not returned and it is hard to reconstruct the situation at the time of procedure.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) 2018: the stent was placed in pylorus due to pyloric stenosis caused by stomach cancer.On (b)(6) 2018: poor passage of food was confirmed and the stent was found being fractured at the center by computed tomography.On (b)(6) 2018: as stenosis was also found, covered stent (niti-s) was placed successfully.Doctor's comment: by seeing ercp imaging, the stent mesh was found not to be extended well (overlapping).It is assumed that the cause of the fracture seems to be placing the stent with pushing by the scope.So, the tumor infiltrated from the pushed part of the stent and a force was applied there.

• 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 8093632
• MDR Text Key: 128020081
• Report Number: 3003902943-2018-00028
• 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: 10/25/2018

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: 07/09/2021
• Device Model Number: DXDT2212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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