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

Model Number EST2012F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.It is hard to find out exact root cause for this complaint, because the suspected device was not returned and it is difficult to reconstruct the situation at that time in the lab and limited info.According to complaint product description, the physician with no tts experience was the user.So, this lack of experience might have contributed to the failure.After our product failure, another provider's otw stent was used on the patient.The otw stent then migrated out of place, it was removed and the patient was sent to surgery.So, it seems that our product was not related to patient injury.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

The stent was difficult to push through the working channel.This resulted in the metal portion of the handle, breaking away from the delivery system.An over the wire (otw) stent from another provider was then used on the patient.The otw stent then migrated out of place, it was removed and the patient was sent to surgery.It was discussed with the customer that a partially covered stent might be a better option in situations like this in the future.The physician with no tts experience was the user.

Manufacturer Narrative

As a result of analysis of returned device, outer sheath was not detached and deployed stent was returned.Pusher was separated from delivery system.It was found curve/kinked mark on inner sheath and outer sheath on the stent loaded part.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 and it is hard to recreate the situation at the time of procedure.It is considered that it was difficult to insert delivery system into scope due to patient's lesion status and user tried to move with pusher.In that situation, pusher was separated from delivery system and it caused deployment failure.We will continuously monitor whether similar or same complaint occurs.

Event Description

The stent was difficult to push through the working channel.This resulted in the metal portion of the handle, breaking away from the delivery system.An over the wire (otw) stent from another provider was then used on the patient.The otw stent then migrated out of place, it was removed and the patient was sent to surgery.It was discussed with the customer that a partially covered stent might be a better option in situations like this in the future.The physician with no tts experience was the user.

• 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, 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: 6291920
• MDR Text Key: 66219502
• Report Number: 3003902943-2017-00004
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Model Number: EST2012F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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
• Patient Age: 59 YR
• Patient Weight: 101