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

Model Number ESP1810FV

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2013

Event Type  malfunction  

Manufacturer Narrative

Since the returned device was destroyed, 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.Since it is difficult to reconstruct the situation at that time in the lab and limited info, it is hard to find out exact root cause for this complaint.We recognize the risk of coating hole, and have been conducted risk management.We will monitor this complaint occurrence for same model.This report is retrospective report due to fda foreign inspection warning letter.The suspected device is not registered to us fda and it has not been shipped into the us.For "a.Patient information", we, taewoon and our distributor could not get more detail patient information because the hospital did not open the patient information such as "age at time of event", "date of birth", "sex" and " weight".

Event Description

(b)(6) 2013 - esp1810fv was implanted to treat a fistula without any problem.(b)(6) 2013: patient came back to the endoscopy unit for trouble and fistula recurrency: an endoscopy was performed which has showed that the contract product passed through the stent (and the cover) in the middle of the stent.The stent was removed and a new stent was positioned without any problem.

• Brand Name: NITI-S ESOPHAGEAL COVERD STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-meyeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4872009
• MDR Text Key: 22527988
• Report Number: 3003902943-2015-00035
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESP1810FV
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization