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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

When the attempt was made to deploy the stent, there was a snap and the blue sheath came unattached from the deploying end of the stent making it unable to deploy.No pt injury and the facility used another tts stent and completed the procedure.

Manufacturer Narrative

First, it is confirmed from the device history record that the subject product had been manufactured with no significant issue and passed all the inspections.As results from investigating the returned device, the outer sheath has been cut off, and stent was partially deployed.Attempting deploy without pressure, it worked well.There were kinked marks at inner sheath.The operated region, esophageal structure, is a part of having an active peristalsis.The pressure occurred from various condition of a patient's lesion can cause a resistance during the deployment.Outer sheath can be stretched and disconnected when the deployment is attempted in such condition.Since it is difficult to reconstruct in the lab and limited information at that time, it is hard to find out exact root cause for this complaint.Also there is no patient's info.This deployment failure seems that it happened because the deployment was attempted with consistent force when the part of stent loaded outer sheath had been snapped, thus eventually cut off.Additionally, as results from investigating the returned device that stent was deployed without any external pressure which may had affected it inside of pt during the operation, it supports the opinion that the outer sheath was damaged by being snapped and thus caused the inoperable condition.This customer complaint occurred in the us.Even though there was no damage to the pt due to this incident, it was decided by the firm that we proceed mdr reporting as an event of product malfunction.The firm will also start monitoring similar cases in case of occurrence in the future.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gajeong-ro, woltot-myeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4792695
• MDR Text Key: 5852728
• Report Number: 3003902943-2015-00023
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2017
• Device Model Number: EST1815F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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