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

Model Number ES2008FD

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 01/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, esophageal double stent 20/80mm was placed.After the placement, the fistula was right in the middle of the stent.The placement was successful.On (b)(6) 2014, 4 days later, during the follow-up gastroscopy, the distal rim of the stent was undercutting the mucosa.

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed actual eval.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 it is difficult to reconstruct the situation at that time in the lab and limited info.We recognize that risk, and have been conducting risk management.Mucosa abrasion by stent sharp edge was reported for the first time since it was released.We will monitor this complaint occurrence for same model.This report is a retrospective report due to a fda foreign inspection warning letter.The suspected device is not registered to u.S.Fda and it has not been shipped into the u.S.For "pt info", we, taewoong and our dist could not get more detail pt info because the hosp did not open the pt info such.

• 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, gejeong-ro, wolgot-myeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4871900
• MDR Text Key: 6063422
• Report Number: 3003902943-2015-00040
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 01/27/2014

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 Expiration Date: 10/21/2016
• Device Model Number: ES2008FD
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Hospitalization