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)

Patient Problem Nausea (1970)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that dxdt2210 was found being fracture where sticking out into the stomach.Based on the attached photo, it was confirmed that part of the fractured stent was removed.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, it is hard to exactly analysis because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.

Event Description

(b)(6) 2021: dxdt2210 was placed for the pyloric stenosis, sticking out into the stomach.(b)(6) 2022: dxdt2210 was found being fracture where sticking out into the stomach in the endoscopy due to the patient complaining of symptoms of nausea, etc.Currently, there were no patient complications, as a result of this event.The fractured stent will be returned.Another part of the fractured stent is still in the pylorus.(b)(6) - (date unknown): another stent was additionally placed in the pylorus.

Event Description

(b)(6) 2021: dxdt2210 was placed for the pyloric stenosis, sticking out into the stomach.(b)(6) 2022: dxdt2210 was found being fracture where sticking out into the stomach in the endoscopy due to the patient complaining of symptoms of nausea, etc.Currently, there were no patient complications, as a result of this event.The fractured stent will be returned.(see attached photo) another part of the fractured stent is still in the pylorus.(b)(6) 2022 (date unknown): another stent was additionally placed in the pylorus.

Manufacturer Narrative

It was reported that dxdt2210 was found being fracture where sticking out into the stomach.Based on the attached photo, it was confirmed that part of the fractured stent was removed.As a result of analysis of returned device, the fractured part of the stent (around 2cm) was returned.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 it is difficult to reconstruct the situation at the time of procedure.However, based on the description "was found being fracture where sticking out into the stomach", it is assumed that fracture occurred due to the strong pressure at the patient's lesion, peristalsis, etc.Complexly.It is assumed that this caused the patient to show symptoms of nausea.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: 15859722
• MDR Text Key: 304281679
• Report Number: 3003902943-2022-00036
• 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,Followup
• Report Date: 11/01/2022

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: DXDT2210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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