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

Model Number ES2015FR2

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stent was in the patient for 3 weeks.There was a hole in silicone membrane.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.According to attached picture, it was found that there was a hole in the middle of the stent.And there were some residue near silicone hole.Existence of hole on the stent is inspected by this firm two times during coating process and half-finished product inspection process.In addition, it is confirmed from the inspection result certificate that it passed successfully.According to complaint product description, the stent was in patient for 3 weeks.It is considered that silicone cover hole might be occurred due to food or body fluid.But the stent was discarded by hospital and there was no patient's info.And it is impossible to identify the exact root cause since it is hard to recreate the situation at the time of procedure.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

The stent was in the patient for 3 weeks.There was a hole in silicone membrane.

• 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19960641
• MDR Report Key: 6188113
• MDR Text Key: 62799244
• Report Number: 3003902943-2016-00045
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2018
• Device Model Number: ES2015FR2
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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