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 Stenosis (2263)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the approximately 6 months after stent placement, the stent above was found being fractured, leading re-stenosis and re-intervention.The stent was fractured at bulb, descending, and pylorus (3 points fractured) and the fractured part on stomach side will be returned.It is confirmed that the foreign substance was solidified on stent cell.Also, as a result of analysis of returned device, the stent was fractured in the part of 3cm and the foreign substance was solidified on stent cell.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.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, based on the description, which was written that "stent above was found being fractured, leading re-stenosis and re-intervention.The stent was fractured at bulb, descending, and pylorus (3 points fractured)" and observed solidified foreign substance, 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.Also, it is considered that strong stenosis pressed the stent, resulted in re-stenosis and re-intervention.It is stated on user manual as follows.Potential complications: stent fracture.Stent occlusion.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 in the patient (pylorus to descending part of duodenum, sticking out to stomach).On (b)(6) 2019: the stent above was found being fractured, leading re-stenosis and re-intervention.The stent was fractured at bulb, descending, and pylorus (3 points fractured) and the fractured part on stomach side will be returned to distributor.Ramucirumab was given.Bsj wallsoft (assuming the boston wall flex soft) and dct2010 were used to finish the procedure.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: 9421250
• MDR Text Key: 185751012
• Report Number: 3003902943-2019-00044
• 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: 11/06/2019

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: 11/25/2021
• Device Model Number: DXDT2208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• 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