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

Model Number EST2015F

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

It was reported that stent was migrated into the stomach, and then tried to reposition the migrated stent in the esophagus, but it migrated to the sigmoid colon.It is hard to confirm the manufacturing history of the product because the serial number was not informed to us.Migration 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.Based on the description, which was written that "a physician had planned to explant the stent, but it migrated into the stomach" and "they tried to reposition the migrated stent in the esophagus, but it migrated to the sigmoid colon", it is assumed that there is a possibility to migrate the stent due to improvement of patient's condition etc, and the user has a possibility to mistake the removal during procedure.However, it is hard to exactly investigate and analysis for this complaint since the patient's information was not provided and it is difficult to reconstruct the situation at the time of procedure with limited information.In addition, based on the description "they found a mass at the site it was stuck.It's either a tumor (less likely) or heaped up tissue from the stent being stuck", there is a possibility that the foreign substance such as food be cumulated and/or that the hole occurred on the stent cover due to stress by migration, foreign substance etc, resulting in the in/over growth.However, it is hard to identify the exact root cause since the suspected device was not returned and 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: stent migration, stent occlusion due to in-growth through stent / over-growth around ends of stent" this complaint couldn't know the root cause, but it is assumed that the migration occurred due to complexly influence on the patient's condition and the user mistake during the procedure etc, there will be continued to monitor the same or similar customer complaints.

Event Description

Firstly a physician had planned to explant the stent, but it migrated into the stomach.Secondly they tried to reposition the migrated stent in the esophagus, but it migrated to the sigmoid colon.Thus (b)(6) 2019 they removed the stent.Additional information: the surgeon was willing to try endoscopic removal himself and was able to get through the stent and grab it with a rotatable rat tooth forceps and remove it by pulling it inside out.They found a mass at the site it was stuck.It's either a tumor (less likely) or heaped up tissue from the stent being stuck.

• 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: 10300177
• MDR Text Key: 199889443
• Report Number: 3003902943-2020-00059
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EST2015F
• Device Catalogue Number: EST2015F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/21/2020
• 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
• Patient Outcome(s): Hospitalization