MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT

Model Number DDT2212

Device Problems Break (1069); Fracture (1260)

Patient Problem Vomiting (2144)

Event Date 05/06/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient had vomited several times and it was found that a part of fractured stent was in a stomach and was removed endoscopically.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.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.Duodenal structure where stent was implanted is curvy.Stent can be pressured and fractured due to patient's lesion status.However, it is hard to find out exact root cause for this complaint because the suspected device was not returned due to it is not sure whether the stent was removed from the patient, and it is difficult to reconstruct the situation at the time of procedure with limited information.Since there was no problem at device history record, it is difficult to judge as fracture caused by device malfunction.It is considered that stent fracture occurred due to patient's lesion.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

(b)(6) 2017: ddt2212 was placed at antrum of stomach.(b)(6) 2017: the patient complained that he/she had vomited several times and then had an x-ray examination.(b)(6) 2017: it was found that a part of fractured stent was in a stomach.It was removed endoscopically and nausea gone away.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 6989551
• MDR Text Key: 90626881
• Report Number: 3003902943-2017-00039
• Device Sequence Number: 1
• Product Code: MUM
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: DDT2212
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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