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

Model Number EST2010F

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that stent had migrated.Also, when the physician went back to the pull the string back up, the string broke.And, some of the silicon came off.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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.It is, however, hard to exactly investigate and analysis for this complaint since it is difficult 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 "stent had migrated in a couple of days", it is assumed that the stent was migrated due to the patient lesion's peristalses, and foreign substance such as foods, body fluids etc.In addition, based on the description, which was written that "when the physician went back to the pull the string back up, the string broke", it is assumed that when the removal or repositioning process of stent the retrieval string, which was some weaken affected by foreign substance such as food, body fluid, etc was applied for excessive tensile force, resulted in retrieval string detachment.And it is considered that the silicon cover was damaged during the stent removal or repositioning process, and some of the silicon came off.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 migration.In addition, warnings: the esophageal tts stent may only be repositioned immediately after deployment, during the initial placement procedure.And the stent is not intended to be removed.This complaint couldn't know the root cause, but it is assumed that it is complexly applied by foreign substance such as food, body fluid and patient's lesion etc, there will be continued to monitor the same or similar customer complaints.

Event Description

The original procedure was on (b)(6) 2019.After which, the physician went back in (in the next or a couple of days) and did an x-ray and saw the stent had migrated.When the physician went back to the pull the string back up, the string broke.Also, some of the silicon came off.The string is off an embedded in the patient's esophagus.

• 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: 9767515
• MDR Text Key: 194839357
• Report Number: 3003902943-2020-00028
• 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 Expiration Date: 04/15/2022
• Device Model Number: EST2010F
• Device Catalogue Number: EST2010F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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