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

Model Number EC1810BH

Device Problem Migration (4003)

Patient Problems Aspiration/Inhalation (1725); Perforation (2001)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that 1 day after stent placement, the stent was perforated and migrated into the chest cavity.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.In addition, migration can occur in any 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 difficult to identify the exact root cause because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "the patient had a coughing during a meal and diagnosed with aspiration.When doing endoscopy, lung parenchyma was found, and the anal side of the stent was perforated and migrated into the chest cavity.", it is assumed that the stent was perforated into the chest cavity due to the condition at the patient's lesion, coughing and other factors complexly.Then, it is assumed the stent was migrated and closed by the esophagus wall due to the condition at the patient's lesion, peristalsis and other factors 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, stent migration".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) 2023: the stent was successfully placed for upper esophageal stenosis, confirming the successful stent placement by imaging.On (b)(6) 2023: the patient had a coughing during a meal and diagnosed with aspiration.When doing endoscopy, lung parenchyma was found, and the anal side of the stent was perforated and migrated into the chest cavity.It was cleaned inside of the chest cavity by doing the thoracic drainage.The value of crp is recovered close to normal value but the patient is unconscious.As a treatment, gastrostomy was performed.The physician does not think the device contributed to this event but is seeking the way to put the stent back into the esophagus or pull the stent from the patient safely.On (b)(6) 2023: as the lower end of stent is closed by esophagus wall, thoracostomy tube is removed, and the physician does not think to remove the stent so much now.Crp value is unknown.The patient does not have chemotherapy and radiation therapy.

• 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: byeoungcheol lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• MDR Report Key: 16580118
• MDR Text Key: 311657201
• Report Number: 3003902943-2023-00007
• 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: 02/28/2023

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 Model Number: EC1810BH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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