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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

(b)(6) 2022: another stent was placed for the duodenal stenosis.(b)(6) 2022: dxdt2208 was additionally placed for re-stenosis due to in-growth by stent-in-stent method.The in-growth was found due to the patient complaining bad condition.(b)(6) 2022: the patient complained bad condition and then an obstruction due to another re-stenosis was suspected, so upper endoscopy was performed, and then the stent was found being partially fractured at 3cm from the mouth edge, where coming out into the stomach.The physician determined to remove the fractured stent (dxdt2208) by forceps and additionally place dct2010bp by stent-in-stent method in the other stent and the procedure was finished.Information of chemotherapy is not available.There were no patient complications as a result of this event.This case is linked to a previous reported case (mdr registration number: #3003902943-2022-00028).This stent fracture case being reported was used with a stent that was previously reported for another case.

Manufacturer Narrative

It was reported that after placement of another stent, in-growth was found and dxdt2208 was placed.3 months later, fracture occurred.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) 2022: another stent was placed for the duodenal stenosis.(b)(6) 2022: dxdt2208 was additionally placed for re-stenosis due to in-growth by stent-in-stent method.The in-growth was found due to the patient complaining bad condition.(b)(6) 2022: the patient complained bad condition and then an obstruction due to another re-stenosis was suspected, so upper endoscopy was performed, and then the stent was found being partially fractured at 3cm from the mouth edge, where coming out into the stomach.The physician determined to remove the fractured stent (dxdt2208) by forceps and additionally place dct2010bp by stent-in-stent method in the other stent and the procedure was finished.Information of chemotherapy is not available.There were no patient complications as a result of this event.This case is linked to a previous reported case (mdr registration number: #3003902943-2022-00028).This stent fracture case being reported was used with a stent that was previously reported for another case.

Manufacturer Narrative

It was reported that after placement of another stent, in-growth was found and dxdt2208 was placed.3 months later, fracture occurred.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 3cm) 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 "stent was found being partially fractured", it is assumed that fracture occurred 3 months later due to the strong pressure at the patient's lesion, peristalsis, etc.Complexly.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, 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: 15507178
• MDR Text Key: 306418510
• Report Number: 3003902943-2022-00029
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DXDT2208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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