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

Model Number EST1806F

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stent started to deploy as the stent was being introduced.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.But there is no device picture and suspected device is not returned yet.So, it is impossible to identify the exact root cause because it is hard to recreate the situation at the time of procedure.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.

Event Description

It was reported that the stent started to deploy as the stent was being introduced.

Manufacturer Narrative

It was reported that the stent started to deploy as the stent was being introduced.As a result of analysis of returned device, outer sheath was not detached and stent was partially deployed.There was curve and kinked mark on stent loaded part.There was gap between yellow marker and stent, and tip was inside of partially deployed stent.When it recaptured, it could be happen.However, this device is unavailable for recapturing.Deployment was tried in the state without pressure and it deployed well.Esophageal structure where procedure was performed has active peristalsis.It can be hard to insert delivery system due to pressure generated by patient's lesion.Pre-deploy can occurred if insertion was tried by force in this situation even though locking valve was locked.However, it is impossible to identify the exact root cause since it is hard to recreate the situation at the time of procedure.It is considered that delivery system was pressured due to patient's lesion status; in that situation, delivery system was bended and stent was partially pre-deployed during advanced toward lesion so it caused pre-deploy failure.We will continuously monitor whether similar or same complaint occurs.

Event Description

It was reported that the stent started to deploy as the stent was being introduced.

• 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 ; 31 9960641
• MDR Report Key: 6445201
• MDR Text Key: 71333228
• Report Number: 3003902943-2017-00011
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Model Number: EST1806F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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 Age: 70 YR
• Patient Weight: 61