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

Model Number ESTXXXXF

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that they physician was using grasping force, the stent would not move, and when using the snare, the stent broke in half.Through the attached photo, it is confirmed that stent was fractured.Also, it is confirmed that foreign substance, blood and body fluids were covered in all stent cover.It is hard to confirm the manufacturing history of the product because the serial number was not informed to us.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.Duodenum 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 root cause since it is difficult to reconstruct the situation at the time of procedure, and the suspected device was not returned.However, based on the description, which was written that "they physician was using grasping force, the stent would not move, and when using the snare, the stent broke in half.", and observed foreign substance, blood and body fluids covered in all stent cover, it is considered that it is hard to remove the stent due to pressure of patient's lesion, and also, the stent removal was tried in some weakened state affected by peristalsis of organs and foreign substance such as food, body fluid, etc, resulted in stent fracture.Through the user manual by taewoong, it is stated that "potential complications associated with the use of esophageal tts stent may include, but are not limited to: stent fracture.In addition, warnings: the stent is not intended to be removed." this complaint is assumed that it was malfunction for device caused by complexity of pressure of patient's lesion, foreign substance, and stent removal process, there will be continued to monitor the same or similar customer complaints.

Event Description

Stent broke in half during removal.The stent was placed about two months ago.The patient was to have the stent removed.They physician was using grasping force, the stent would not move, so the physician switched to using a snare.When using the snare, the stent broke in half.The remaining portion was removed with the snare successfully with no adverse events.

• 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: 9767792
• MDR Text Key: 194843245
• Report Number: 3003902943-2020-00029
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123205
• 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: 02/03/2020

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 Model Number: ESTXXXXF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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