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

Model Number BS1004FW

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the edge of the stent tulip injured the tissue in the intestinal wall, and the patient had bleeding in the intestine.As a result of analysis of returned device, only the stent was returned.Foreign substances were observed on the proximal flare of the stent.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Perforation 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.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 information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "edge of the stent tulip injured the tissue in the intestinal wall, and the patient had bleeding in the intestine", it is assumed that perforation occurred at the tissue at the edge of stent flare due to the strong pressure of the stenosis and other elements complexly, then bleeding occurred.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: perforation, bleeding".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

The edge of the stent tulip injured the tissue in the intestinal wall.The patient had bleeding in the intestine, so the stent had to be removed.

• Brand Name: NITI-S BILIARY COVERED 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: 12119611
• MDR Text Key: 260029552
• Report Number: 3003902943-2021-00023
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2023
• Device Model Number: BS1004FW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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