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

Model Number BKM1006CW

Device Problems Break (1069); Fracture (1260)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that 5 months after stent placement, on pulling out of stent the stent fractured as it was removed into two parts.Based on the attached photos, it is confirmed that half of the stent was fractured during removal and was removed, and the part left was also removed.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Fracture 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.Biliary structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture be possible.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 hard to identify the exact root cause since the device was not returned, and it is hard to reconstruct the situation at the time of procedure.However, based on half of the stent being fractured during removal and removed, and the part left also being removed in the attached photos, it is considered stent fracture occurred due to the combination of continuous stress on the stent from the pressure generated from the patient's lesion, excessive tensile force applied to the stent during removal, and other factors complexly.And then, it is considered the stent was completely removed.In the user manual by taewoong, it is stated that "fully covered stent may be removed within 6 months.Stent removal shall be performed by doctor according to the etiology of the benign stricture and the patient's conditions." and "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent fracture".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 had been implanted (b)(6) 2023 and removal was on (b)(6).On pulling out of stent the stent fractured as it was removed into two parts.It did not fail in patient.The stent was fractured during removal from the bile duct.The patient/user was not affected.(b)(6) 2023: the dt product specialist was informed by the physician of a bumpy stent that fractured on removal in (b)(6).Photos was requested and will be forwarded when received by distributor.Additional information on 2023.09.11: a snare was placed over the distal aspect of the stent to facilitate removal however stent snapped at the mid portion leaving other half of stent floating in the bile duct.No trauma to the patient was present, and the stent was removed in full.

• Brand Name: NITI-S BILIARY COVERED STENT
• Type of Device: BILIARY 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: 17796088
• MDR Text Key: 324020780
• Report Number: 3003902943-2023-00028
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: BKM1006CW
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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