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

Model Number EC1810BH

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that 3 months after stent placement at mid-lower esophagus, in-growth and bleeding were confirmed.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Esophageal structure where stent implanted is the part with active peristalsis.It is possible that the stent could be pressed and stent in/over-growth could occur by state of patient's lesion.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 cause since it is hard to reconstruct the situation at the time of procedure and the device was not returned and the information such as photo was not provided.However, based on the description "3 months after stent placement, in-growth and bleeding were confirmed", it is assumed that the stent in-growth occurred due to pressure of the patient lesion, peristalsis and foreign substance.Also, based on the description, it is assumed that the bleeding occurred due to the procedure process, but it is hard to identify the exact cause since it is hard to reconstruct the situation at the time of procedure and the procedure information was not enough.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: stent occlusion, tumor in-growth, 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) 2020: ec1810bh was placed at mid-lower esophagus due to esophageal cancer.On (b)(6) 2020: in-growth and bleeding were confirmed.

• 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, 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: 10827153
• MDR Text Key: 217668308
• Report Number: 3003902943-2020-00098
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: EC1810BH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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