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

Model Number EC1812AR

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that free air was observed after 3 weeks from the stent implantation.The stent is not removed from the patient.The surgeon speculated that the patient's fever was caused by perforation.For reducing fever, oral intake had prohibited, and it was improved, the patient was discharged.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.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.It is hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure.The suspected device was not removed from the patient, so it is difficult to judge perforation caused by device malfunction.It is considered that perforation was occurred due to complexity of patient's lesion status and stent implantation.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) 2016.Chemoradiotherapy (crt) was performed on unrespectable cancer.After that, chemotherapy was continued.Date unknown.The patient narrowed the esophagus by the exacerbation of esophageal cancer and became poor oral intake.On (b)(6) 2017.Ec1812ar was applied to the lower esophagus, and the patient's esophageal narrowing improved.On (b)(6) 2017.Chemotherapy (docetaxel + nedaplatin) was resumed.On (b)(6) 2017.The patient has a fever.On (b)(6) 2017.X - ct found a small amount of bubbles in the esophagus (esophagus mediastinum) of the stent placement part.The physician speculated that the patient's fever was caused by perforation.Oral intake has prohibited, as a conservative therapy.On (b)(6) 2017.The patient's fever improved.On (b)(6) 2017.Oral intake was permitted.On (b)(6) 2017.The patient was discharged.Physician's comment: as palliative treatment, stent placement was done.It has been more than one year since crt, but the weakness of esophageal tissue and resumption of chemotherapy may have adversely affected.

• 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, 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• MDR Report Key: 7308749
• MDR Text Key: 101345589
• Report Number: 3003902943-2018-00005
• 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: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: EC1812AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• 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