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

Model Number DXDT2210

Device Problems Break (1069); Fracture (1260); Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

It was reported that the stent was placed from duodenum to stomach on (b)(6) 2019, and it was found being fractured at duodenal bulb and migrated down to the anal side in the other day.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.Migration 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.It is, however, hard to exactly investigate and analysis for this complaint since it is difficult to reconstruct the situation at the time of procedure.It is hard to identify the root cause since it is difficult to reconstruct the situation at the time of procedure, and the patient's information is limited, and the suspected device was not returned.However, based on the description, which was written that "stent was placed from duodenum to stomach on (b)(6) 2019, and it was found being fractured at duodenal bulb and migrated down to the anal side in the other day.", it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure, and foreign substance such as foods, body fluids and so on.And, it is assumed that the fractured stent was migrated to anal side due to the patient lesion's peristalses, and foreign substance such as foods, body fluids etc.In addition, based on the description, which was written that "tissue already came into the stent mesh.The stenosis part was still patent", it is considered that the patient's tissue was in/over growth on the stent mesh due to the strong pressure of patient's lesion.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, stent migration, tumor in/over-growth." 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

The stent was placed from duodenum to stomach on (b)(6) 2019, and it was found being fractured at duodenal bulb and migrated down to the anal side in the other day.It is unknown when the event was exactly found though.The physician concerned the perforation and thought about removing the fractured stent, however, determined not to remove considering the removing risk because tissue already came into the stent mesh.The stenosis part was still patent, so the physician will monitor how it goes.

• 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: 9691237
• MDR Text Key: 192401224
• Report Number: 3003902943-2020-00009
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: DXDT2210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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