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

Model Number EC1812AR

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Abdominal Pain (1685); Inflammation (1932)

Event Date 05/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, esophageal stent ((b)(4)) was used at malignant stricture near cardiac portion of the esophagus.No problem was admitted and procedure was finished successfully.On (b)(6) 2014, the pt visited the hosp due to epigastralgia.Scope admitted the following: the long-covered part was missing and inflammation was admitted at the edge of stent.Reportedly, physician commented that it's not confirmed whether the long-covered part was detached or meltdown.As for the future interventions, ic and other stent implantation will be performed.

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to 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 the suspected device was not returned and it is difficult to reconstruct the situation at that time in the lab and limited info.The complaint of missing anti-valve was reported for the first time since it was released.But we will continue to be monitored for similar complaint, if reoccur.This report is a retrospective report due to a 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.Pt info", we, taewoong and our dist could not get more detail pt info because the hosp did not open the pt info.

• Brand Name: NITI-S ESPOHAGEAL 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-myeon; gimpo-si, gyeonggi-do ; 19960641
• MDR Report Key: 4871917
• MDR Text Key: 6064362
• Report Number: 3003902943-2015-00046
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2017
• Device Model Number: EC1812AR
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Hospitalization