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

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Perforation (2001); Septic Shock (2068)

Event Date 07/16/2018

Event Type  Death  

Manufacturer Narrative

It was reported that patient presented abdominal pain and fevers 9 days after placement and 11 days later died.Post modem showed perforation in the cbd.It is hard to review suspected device's dhr because the serial no.Was not checked.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 the device was not returned, information such as photos were not provided and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "post modem showed perforation in the cbd" and "could have been due to the brush", it is assumed that perforation occurred due to the strong pressure of the stenosis, procedure and other elements complexly, then the patient died due to septic shock.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." 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 patient re-presented 9 days later with abdominal pain and fevers.Ct showed a collection in the lesser sac.This was not amenable to drainage.The patient was treated with antibiotics.11 days later he developed septic shock and unfortunately died.A post mortem showed a collection of pus behind the common bile duct (cbd) and documented a perforation in the cbd.On 2022.10.21 additional information: the doctor does not think the localised perforation was due to the stent itself - but could have been due to the brush (to take brushings).

• 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, 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: 15664887
• MDR Text Key: 302320879
• Report Number: 3003902943-2022-00033
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• 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): Death; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male