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

Model Number EST1815F

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.It is impossible to identify the exact root cause since the device was not returned and it is hard to recreate the situation at the time of procedure with limited information.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.We will continuously monitor whether similar or same complaint occurs.

Event Description

Stent would not deploy.Felt a "pop" when deploying stent but stent would not open.No harm to patient.

Manufacturer Narrative

As a result of investigation of returned device, outer sheath was detached, stent was loaded, and mark being kinked were found near stent loaded part and yellow marker.Deployment was tried in the state without pressure, and it worked well.Esophageal structure where procedure was performed has active peristalsis.It can be hard to deploy due to pressure generated by patient's lesion status.Outer sheath can be stretched and detached and it can cause deployment failure if deployment was tried in this situation.It is, however, impossible to identify the exact root cause since there is no patient information and it is hard to recreate the situation at the time of procedure.It is regarded that outer sheath got pressured by patient's lesion status and deployment was tried in this situation according to the investigation in which deployment was successful in the state without pressure.It seems that deployment failure occurred since it was hard to deploy due to kinked outer sheath and it caused detachment of outer sheath.We will continuously monitor whether similar or same complaint occurs.For "a.Patient information", we, taewoong and our distributor could not get more detailed patient information because the hospital did not open them such as "2.Age at time of event", "date of birth", "3.Sex" and "4.Weight".

Event Description

Stent would not deploy.Felt a "pop" when deploying stent but stent would not open.No harm to patient.

• 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19960641
• MDR Report Key: 5479065
• MDR Text Key: 39986748
• Report Number: 3003902943-2016-00011
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2018
• Device Model Number: EST1815F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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