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

Model Number BNC1206F

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the rupture of aneurysm was found for the patient with bcn1206f placed in the past.The aneurysm was around the center of the stent and the physician performed embolization, however, another aneurysm was developed further.It is hard to review suspected device's dhr, because the serial no was not checked.It is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure, the device was not returned, and information such as photo was not provided.However, based on the description "the physician's comment: it is hard to consider the stent placement contributed to the aneurysm and there is a patient susceptible to aneurysm", it is considered that the aneurysm has occurred due to condition of patient's lesion, and then it was ruptured, so embolization was performed by physician, but another aneurysm was developed further.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: 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

On (b)(6) 2021: the rupture of aneurysm was found for the patient with bcn1206f placed in the past.The aneurysm was around the center of the stent and the physician performed embolization, however, another aneurysm was developed further.According the comment by physician, it is hard to consider the stent placement contributed to the aneurysm and there is a patient susceptible to aneurysm.

• 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: 11954802
• MDR Text Key: 254859972
• Report Number: 3003902943-2021-00021
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BNC1206F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• 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