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

Model Number CDT2412

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stent was removed from the patient due to stent migration from sigmoid colon to rectum.Also, it was reported that there was no patient injury.According to attached endoscopy that taken in (b)(6) 2017, it was confirmed that the stent was migrated to rectum.As a result of analysis of returned delivery system without stent, it was found curve on outer sheath and inner sheath near stent loaded part.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.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.According to the curvature of the returned delivery system, it was appeared that the delivery system was influenced by the stenosis.And the stenosis has made it difficult to expansion of stent.In the end, it was considered that the stent is unable to get a position and that caused the migration.It is, however, hard to find out exact root cause for this complaint because it is difficult to reconstruct the situation at the time of procedure with limited information.According to device history records, there was no problem with that device.So it is difficult to judge migration by device malfunction.Because the delivery system was influenced by patient's lesion during the procedure, it is assumed that the stent migration occurred.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

Dr.(b)(6) complained the introducer system of the niti-s enteral colonic uncovered stent kinked easily during the procedure.For the first case, the stent migrated, he had no way but to deploy the second stent, so he asked to get the replacement for the migrated stent.The details of introducer systems are as follows: cdt2412 - lot no.17e1430d7ec299 (stent migration) - dr.(b)(6) kept the kinked introducer system, and he can return it for your inspection.Additional description from the distributor: after checking with dr.(b)(6) again, the first stent migrated from sigmoid colon to rectum.Dr.(b)(6) also advised us that finally the migrated stent had been removed from the patient.There was no patient injury.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT, PRODUCT CODE
• 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• MDR Report Key: 7137161
• MDR Text Key: 96054306
• Report Number: 3003902943-2017-00043
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/01/2017

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 Expiration Date: 05/25/2020
• Device Model Number: CDT2412
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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