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

Model Number ES2823F

Device Problem Material Perforation (2205)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 the doctor placed a niti-s megastent (ref es2823f, lot bg10001bie0021) for the treatment of an anastomotic leak.In the subsequent endoscopic evaluation (19/12) the doctor found the existence of a continuity solution in the covering of the body of the stent, which is why it was removed and another one with the same characteristics was placed on 20/12.The doctor has videos of the holes inside the prosthesis with pus drainage when still implanted and ex-vivo testing.

Manufacturer Narrative

It was reported that after stent placement, holes inside the prosthesis were found and was removed.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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 followup report accordingly.

Event Description

On (b)(6) 2023 the doctor placed a niti-s megastent (ref es2823f, lot bg10001bie0021) for the treatment of an anastomotic leak.In the subsequent endoscopic evaluation (b)(6) the doctor found the existence of a continuity solution in the covering of the body of the stent, which is why it was removed and another one with the same characteristics was placed on (b)(6).The doctor has videos of the holes inside the prosthesis with pus drainage when still implanted and ex-vivo testing.

Manufacturer Narrative

It was reported that after stent placement, holes inside the prosthesis were found and was removed.As a result of analysis of returned device, only the stent was returned.There was small hole in the silicon cover of 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.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 small hole in the cover of the stent, there is a possibility it 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: 18577136
• MDR Text Key: 334751939
• Report Number: 3003902943-2024-00004
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES2823F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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