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

Model Number DDT1812

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

According to the report, the stent was found to be fractured around pylorus and fractured stent fell into the stomach.It was decided to keep monitoring continuously without additional treatment.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 pylorus where stent was implanted is curvy and especially, has a lot of momentum.Stent can be frequently pressured due to patient's lesion status and fracture be possible.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, the stent was not removed from the patient, and was left inside the patient's body, therefore it is difficult to judge fracture as a result of product malfunction.Also, it is difficult to reconstruct the situation at the time of procedure with limited information.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 (b)(6) 2018: the stent was placed from body through antrum and pylorus of stomach to duodenum against the stomach cancer.On (b)(6) 2018: the stent was found to be fractured around pylorus and fractured stent fell into the stomach.It was decided to keep monitoring continuously without additional treatment.There were no patient complications as a result of this event.

• 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: 7968328
• MDR Text Key: 126089820
• Report Number: 3003902943-2018-00023
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2018

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: 05/24/2020
• Device Model Number: DDT1812
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• 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