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

Model Number EST2012F

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that device separated at handle during implant; used a 2nd device to complete procedure.As a result of analysis of returned device, outer sheath was detached and stent was returned in state of partially deployed.There are the fluent curves on stent loaded part, and the kinked mark was observed on the sheath in front of the yellow marker.Deployment was tried without pressure, and it deployed well.The inner sheath was also observed to be kinked mark at the front of the yellow marker.Duodenum structure where stent was implanted is curvy.Resistance can be felt due to pressure generated by patient's lesion during deployment.It can cause deployment failure if deployment is tried by force in this situation since outer sheath can be stretched and detached.However, it is impossible to identify the exact root cause since it is hard to recreate the situation at the time of procedure.Therefore, based on the observed kinked mark of outer/inner sheath, and deployment well under the none pressure, it is considered that delivery system was pressured due to patient's lesion during procedure and deployment was tried in that situation.It was hard to deploy due to pressure/curved sheath, in which was concentrated the force, the strong resistance occurred, and leaving the kinked mark, and the outer sheath was detached in the end, so, it caused deployment failure.In addition, the relevant product was manufactured for use in esophagus, but it was reported that the user who used the product has used product in duodenal stricture according to the customer complaint description.It is stated on user manual by this firm in order to prevent these problems as follows: indication for use: the niti-s comvi esophageal stent is intended for maintaining esophageal luminal patency in malignant strictures.Contraindication: any use other than those specifically outlined under indications for use.This complaint is assumed that it was malfunction due to pressed by patient's lesion.And the user has used the product to duodenal stricture instead of using it in the intended location (esophagus).There will be continued to monitor the same or similar customer complaints.

Event Description

Device separated at handle during implant; used a 2nd device to complete procedure.Whole device available for return.No adverse effects experienced by 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 8177642
• MDR Text Key: 131794184
• Report Number: 3003902943-2018-00034
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2018

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: 12/28/2020
• Device Model Number: EST2012F
• Device Catalogue Number: EST2012F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2017
• 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