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

Model Number DXDT2210

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Stenosis (2263)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that 2 months after stent placement, in-growth was found and another stent was placed.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: dxdt2210 was placed for the duodenal stenosis.(b)(6) 2022: another stent 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.Information of chemotherapy is not available.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that 2 months after stent placement, in-growth was found and another stent was placed.The device was reported to be returned, but only another device that was used with the stent was returned, so we report the final report.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Duodenum structure where stent was implanted is curvy.It is possible that the stent could be pressed and stent in-growth could occur by state of patient's lesion.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 "re-stenosis due to in-growth", it is assumed in-growth and re-stenosis occurred on the uncovered stent due to the strong pressure of patient's lesion, peristalsis and foreign materials, etc.The device is an uncovered device, therefore in-growth is expected.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: tumor in-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

2022/4/5: dxdt2210 was placed for the duodenal stenosis.2022/6/6: another stent 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.Information of chemotherapy is not available.There were no patient complications as a result of this event.

• 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: 15507090
• MDR Text Key: 300874156
• Report Number: 3003902943-2022-00028
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXDT2210
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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