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

Model Number ES2823FR2

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

It was reported that after 3-4 weeks of stent placement, a hole was found in the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the attached photo, it is confirmed that the stent was removed, and there is a hole with a diameter of approximately 1mm in the stent.However, it is hard to exactly analyze because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.

Event Description

During a ct scan, a leakage was detected in a "freshly" placed esophageal stent.After endoscopic stent removal, a "hole" could be documented.(see attached photo, the hole is clearly visible in the center of the image).The stent has been preserved here and can be made available to you.Additional information on (b)(6) 2023.Stent was implanted for approx.3-4 weeks.

Event Description

During a ct scan, a leakage was detected in a "freshly" placed esophageal stent.After endoscopic stent removal, a "hole" could be documented.(see attached photo, the hole is clearly visible in the center of the image).The stent has been preserved here and can be made available to you.Additional information on 2023.07.12.Stent was implanted for approx.3-4 weeks.

Manufacturer Narrative

It was reported that 3-4 weeks of stent placement, a hole was found in the stent.Based on the attached photo, it is confirmed that the stent was removed, and there is a hole with a diameter of approximately 1mm in the stent.As a result of analysis of returned device, only the stent was returned.There were foreign substances like blood on the middle of the stent, and a small hole occurred.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.Based on the foreign substances and hole in the stent, there is a possibility cover hole might have occurred after placement due to pressure of patient's lesion, foreign substance and body fluid, etc.Complexly.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.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.

• 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: 17456184
• MDR Text Key: 320535714
• Report Number: 3003902943-2023-00024
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES2823FR2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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