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

Model Number EK2420FNT2

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that on removal of beta stent it was found that the stent had fractured.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Fracture can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.The ek2420fnt2 is beta2 stent.Stent body is made of d-type cell and outer stent is made of s-type cell.Normally, the beta stent is implanted at cardias and it is possible to be fractured stent body due to affected by foreign substance such as food, body fluids, and/or shrinkage-relaxation of stomach.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned and there was lack of patient's, and photo's info, also it is difficult to reconstruct the situation at the time of procedure with limited information.However, it is stated on user manual as follows.Potential complications: potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent fracture.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

On removal of beta stent it was found that the stent had fractured.No adverse event caused to patient.

• 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: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 8521522
• MDR Text Key: 142194249
• Report Number: 3003902943-2019-00010
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: EK2420FNT2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• 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