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

Model Number EA1815FD

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

It was reported that after 2 weeks of insertion, a skirt problem had occurred.The patient has a problem of eating.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.As a result of analysis of attached picture, it was confirmed that stent skirt was rolled up partially.Esophageal structure where stent implanted is the part with active peristalsis.Stent skirt might be affected due to pressure generated depending on patient's lesion, food and body fluid.But that device was not returned and there was no patient info.And also, it is impossible to identify the exact root cause because it is hard to recreate the situation at the time of procedure.Since there was no problem at device history record, it is considered that after stent insertion, skirt had affected due to food/body fluid; the skirt was rolled up partially and patient had problem of eating.So it caused complaint.We will continuously monitor whether similar or same complaint occurs.

Event Description

After 2 weeks of insertion, a skirt problem had occurred.The patient has a problem of eating.

• 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; 19906441
• MDR Report Key: 6327947
• MDR Text Key: 67336064
• Report Number: 3003902943-2017-00005
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: EA1815FD
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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