MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S BILIARY SUPREMO STENT; BILIARY STENT

Model Number BSD1008FW

Device Problem Insufficient Information (3190)

Patient Problem Stenosis (2263)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that about 1 years after the stent placement, re-obstruction was confirmed at the stent placed part.It is hard to review suspected device's dhr, because the serial no was not checked.Biliary structure where stent was implanted is narrow and curvy.It is possible that the stent could be pressed 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 hard to identify the exact cause since it is hard to reconstruct the situation at the time of procedure and the device was not returned and the information such as photo was not provided.However, based on the description, "re-obstruction might be caused by the increase of malignant tumor through the mesh." it is assumed that the stent was pressed due to the strong pressure of the patient lesion and progress of disease, resulting in re-obstruction.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: bile duct obstruction." 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

Bsd1008fw (s/n: unknown) was placed for the malignant stenosis in mid-lower bile duct about one year ago.On (b)(6) 2020, re-obstruction was confirmed at the stent placed part.Therefore, the physician placed another stent in stent-in-stent method.Re-obstruction might be caused by the increase of malignant tumor through the mesh.There were no patient complications as a result of this event.

• Brand Name: NITI-S BILIARY SUPREMO STENT
• Type of Device: BILIARY 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: 11000880
• MDR Text Key: 221241295
• Report Number: 3003902943-2020-00101
• Device Sequence Number: 1
• Product Code: FGE
• 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
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BSD1008FW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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