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

Model Number EC1815BH

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Perforation (2001)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the stent was placed in the patient and the patient got fever in the night, and free air was found, and perforation was suspected.It was confirmed from the device history record that device had been manufactured with no significant issue 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.Based on the description, which was written that "patient was originally in a bad condition" and the performed procedure (total gastric resection), it is not clear that the free air caused by perforation by using the stent.However, when using the stent on the anastomotic part, it is possibility to occur the perforation due to complexly influence on the pressure of the patient's lesion and patient's condition, and free air occurred, and then, the fever has occurred on the patient, but it is hard to find out exact root cause since there is no further information such as photo, progress description, and it is difficult to reconstruct the situation at the time of procedure.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

(b)(6) 2020: the stent was placed in the patient and the patient got fever in the night.The physician checked it through ct image, then, free air was found, and perforation was suspected.The physician considered removing the stent but determined to monitor how it would go without removing it because the patient was originally in a bad condition.

• Brand Name: NITI-S ESOPHAGEAL COMVI STENT
• Type of Device: ESOPHAGEAL 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: 10294115
• MDR Text Key: 199888601
• Report Number: 3003902943-2020-00053
• Device Sequence Number: 1
• Product Code: ESW
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: EC1815BH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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