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

Model Number EST1808F

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

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that approximately 18 months, two stents were found being migrated to stomach side for about 4cm.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.Based on the description, "approximately 18 months, two stents were found being migrated to stomach side for about 4cm," it is assumed that the migration has occurred due to the patient's lesion status, peristalsis of organs, and drug use.However, it is hard to exactly investigate, and analysis for this complaint since it is difficult to reconstruct the situation at the time of procedure with provided information.Through the user manual by (b)(4), it is stated that, "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: migration." this complaint is assumed that it was malfunction for device due to pressure of patient's lesion, peristalsis of organs, drug use etc complexly, and there will be continued to monitor the same or similar customer complaints.

Event Description

On (b)(6) 2019, an over-growth was found on the proximal side of ec1810ar above, so est1808f was additionally placed there.On (b)(6) 2019, two stents (first inserted ec1810ar stent and additionally inserted est1808f stent) were recently found being migrated to stomach side for about 4cm when checking obstruction under a scope.They were not removed and another stent (ec1812bh) was additionally placed.There were no patient complications as a result of this event.

• 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: 10695392
• MDR Text Key: 211873519
• Report Number: 3003902943-2020-00084
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 09/21/2020

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: 12/27/2021
• Device Model Number: EST1808F
• Device Catalogue Number: EST1808F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2018
• 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