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

Model Number EST1810F

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that another stent was placed, and around 9 weeks later it was removed and after removal, re-stenosis was found and est1810f was placed.After around 1 month, perforation was found on the proximal side 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 hard to identify the exact root cause since the device was not returned, information such as photo was not provided, and it is hard to reconstruct the situation at the time of procedure.However, based on the description "restenosis was found and est1810f was placed in the esophagus", it is assumed that perforation occurred due to the strong pressure of the stenosis and other elements complexly.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 complaint couldn't know the root cause, but it is assumed to have been caused by the strong pressure of the stenosis and other elements complexly.There will be continued monitoring of the same or similar customer complaints.

Event Description

(b)(6) 2020 : another stent (est1812f) was placed for fistula and light stenosis in esophagus.9 weeks later: the stent was removed and the fistula closure was confirmed.(b)(6) 2021 : restenosis was found and est1810f was placed in the esophagus (10cm away from egj towards the mouth).(b)(6) 2021 : perforation was found at the mouth side of stent (not at the fistula closure point).Surgery will be performed, and the patient is currently under off-food without any problem.

• Brand Name: NITI-S ESOPHAGEAL COVERED 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: 11698684
• MDR Text Key: 249482081
• Report Number: 3003902943-2021-00013
• Device Sequence Number: 1
• Product Code: ESW
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: EST1810F
• Device Catalogue Number: EST1810F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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