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

Model Number EC1610

Device Problem Insufficient Information (3190)

Patient Problems Airway Obstruction (1699); Dyspnea (1816)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that right after the stent placement in esophagus, the patient complained the difficulty in breathing.Observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.It is hard to consider it as the complaint by device malfunction since the stent was normally deployed.However, based on the description "observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus", it is assumed that after the stent placed in the esophagus, the pushed stenosis was partially obstructing the bronchus, therefore, the patient felts the difficulty in breathing, but it is hard to identify the exact cause since it is hard to reconstruct the situation at the time of procedure and the information such as photo was not provided.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: airway compressions".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

Right after the stent placement in esophagus, the patient complained the difficulty in breathing.Observing the bronchus in bronchoscope, the stenosis pushed by stent placement in esophagus was obstructing the bronchus.The stent was removed, and the procedure was finished.There were no patient complications as a result of this event.

• 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: 11093288
• MDR Text Key: 229816319
• Report Number: 3003902943-2020-00105
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: EC1610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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