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

Model Number EST2008F-18

Device Problem Material Perforation (2205)

Patient Problem Erosion (1750)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that after stent placement about 1 week, multiple holes on silicon membrane of the covered stent were found with tissue ingrown.Through the attached photo, it is confirmed that the in-growth occurred inside the stent, and after removed, large amount of blood was observed on stent cover, and removed with patient's tissue.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.Inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.It is confirmed from the inspection result certificate that it passed successfully.Therefore, it is hard to consider this case due to manufacturing error.However, based on the in attached 1st photo, which is clean-looking stent cover and the cover holes were not seen, it is assumed that silicone cover hole might be occurred due to complexly influence by pressure of patient's lesion and foreign substance such as food and body fluid etc.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.In addition, it is assumed that the patient's tissue was grown inside the stent due to pressure of the patient's lesion etc, after occurring the cover hole.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: cover breakdown with ingrowth of the mucosa".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

The stent was positioned inside the patient for about 1 week ago on (b)(6) 2021.Multiple holes on silicon membrane of the covered stent were found with tissue ingrown.Dr took the damaged stent out.Upon examination of the stent, multiple holes were seen on silicon membrane but the metal part of the stent remained intact.Dr used another stent (es2412f), and terminate the procedure.

• 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: 11698501
• MDR Text Key: 249481331
• Report Number: 3003902943-2021-00012
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: HK
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: EST2008F-18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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