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 Erosion (1750)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that, approximately 4 months after stent deployment, the part of the stent in the stomach was fractured, and the fractured stent is currently in the stomach, also, the stenosis part where the other part of the stent remains is getting narrowed due to in-growth but not completely obstructed.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 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.Duodenum structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture 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, the stent was not returned.Based on the description, which was written that "the part of the stent in the stomach was fractured, and the fractured stent is currently in the stomach.It seems to be hard to remove the fractured stent because there is also a stenosis in the cardia even though the endoscope can pass." it is assumed that the wire was somewhat weakened due to the patient lesion's peristalses and pressure and foreign substance such as foods, body fluids and so on, resulted in stent fracture.Also, it is assumed that the part of patient lesion was in-growth into the uncovered stent cell due to stenosis.It is stated on user manual as follows.6.Potential complications: stent fracture.Tumor ingrowth.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) 2019: dxdt2208 was placed with sticking out of pylorus into the stomach.On (b)(6) 2019 (receipt date of the event information).The part of the stent in the stomach was fractured, and the fractured stent is currently in the stomach.It seems to be hard to remove the fractured stent because there is also a stenosis in the cardia even though the endoscope can pass.There is no adverse event so far, however, the stenosis part where the other part of the stent remains is getting narrowed due to in-growth but not completely obstructed.Therefore, additional stents may be placed if the stenosis becomes stronger in the future.

• 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: 8958892
• MDR Text Key: 156979658
• Report Number: 3003902943-2019-00029
• 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: 08/12/2019

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: 01/06/2022
• Device Model Number: DXDT2208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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