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

Model Number EST1815F

Device Problems Break (1069); Fracture (1260)

Patient Problems Erosion (1750); Vomiting (2144)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that approximately 12 days after stent placement, the stent had fractured in the middle and the tumor was coming through the break in the nitinol inside the stent causing a blockage on oesophagus.Through the attached photo, it is confirmed that the stent middle part was partially fractured, and foreign substance was attached on the cover.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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.Esophageal structure where stent implanted is the part with active peristalsis.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 "approximately 12 days after stent placement, the stent had fractured in the middle and the tumor was coming through the break in the nitinol inside the stent causing a blockage on oesophagus.", and the confirmation that the foreign substance was attached on the cover, it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure, and foreign substance such as foods, body fluids and so on.And the tumor was in growth inside the fractured part of stent due to the strong pressure of patient's lesion.Then, it is considered that the patient was unwell and vomiting since the esophageal was partially blocked by in-grown tumor.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: stent fracture, tumor in-growth, reflux".This complaint is assumed that it was malfunction for device due to pressure of patient's lesion, there will be continued to monitor the same or similar customer complaints.

Event Description

Patient had est1815f inserted successfully on (b)(6) 2020 then on (b)(6) 2020 patient presented to hospital unwell and vomiting.On investigation it was seen that the stent had fractured in the middle and the tumor was coming through the break in the nitinol inside the stent causing a blockage on oesophagus.The stent was removed intact and patient is now awaiting a further procedure to replace the stent.

• 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: 9827818
• MDR Text Key: 196413408
• Report Number: 3003902943-2020-00032
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: EST1815F
• Device Catalogue Number: EST1815F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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