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); Migration or Expulsion of Device (1395)

Patient Problem Stenosis (2263)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

According to the report, when restenosis was found and tested through fluoroscopy, half of the stents were fracture and other stents were placed.The fractured stent is migrated, but in the opinion of the physician, it was eliminated naturally because stent is not found in the lower abdomen.Also, it seems that stenosis has regenerated because stent was partially migrated.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 removed from the patient, and it is impossible to perform precise examination because the product was not returned.It is considered that fracture was occurred due to complexity of patient's lesion status and stent implantation.Also, although the fractured stent is migrated, it seems to have been emitted naturally out of the body.However, 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)(4) 2017: the stent was placed from body through antrum and pylorus of stomach to duodenal bulb against primary disease stomach cancer (stage 4).2018/2/16: restenosis was found (it is unknown when it exactly occurred) and stent in stent procedure was performed.When checking it in fluoroscopy before inserting endoscope, it could not be checked because a half of the stent on anal side was fractured.During seeing ct image taken in the past, the whole image could be checked on (b)(6) 2017 and it seems that the stent was not fractured on (b)(6) 2018.On (b)(6) 2018/: another stent was placed to the location.Physician's comment: it is assumed that the fractured stent was already eliminated because stump of the stent was not found in lower abdomen.

• 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: 7521151
• MDR Text Key: 108488458
• Report Number: 3003902943-2018-00014
• 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: 04/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: DDT1812
• 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: 04/30/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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