MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT

Model Number CDT2208

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

It was reported that stent migration occurred because stenosis was relieved thanks to chemotherapy.It was impossible to review suspected device's dhr, because it was not confirmed serial no.And it is impossible to return suspected device because stent is still in patient's body.Migration 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.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned, a picture of the relevant device is not and it is difficult to reconstruct the situation at the time of procedure with limited information.According to customer complaint description, after the chemotherapy performed, stent migration occurred.So it is difficult to judge migration by device malfunction.If a stent is inserted in the lumen once, stent is expanded and kept expansion in accordance with diameter of the lumen in conditions inside the human body, because raw material of the stents produced in taewoong medical is nitinol shape memory alloy.A reason of this customer complaint is considered that migration was occurred because diameter of the lumen is expanded due to chemotherapy.There is additional information about the relevant device such as a picture.Also, it is impossible to identify the exact root cause because it is hard to recreate the situation at the time of procedure.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

The stent was placed at sigmoid colon on (b)(6) 2014.After the placement, stent migration occurred because stenosis was relieved thanks to chemotherapy (around sigmoid descending colon junction to around recto sigmoid).The stent could not be removed because of ingrowth.It would be removed in a surgery.There were no patient complications as a result of this event.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC 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: 6989548
• MDR Text Key: 91445444
• Report Number: 3003902943-2017-00038
• Device Sequence Number: 1
• Product Code: MQR
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDT2208
• 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
• 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