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

Model Number DCT2412BP

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

According to the report, after stent was placed, chemotherapy began and it was later discovered that the stent was transferred to the small intestine.In addition, when the stent was transferred to the small intestine in 2018, the perforation had occurred.Since the manufacturing history of the product cannot be confirmed, it is difficult to confirm that it has passed normal manufacturing and inspection.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 and it is difficult to reconstruct the situation at the time of procedure with limited information.Also, perforation 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.In this patient, it is assumed that perforation and migration was occurred due to complexity of patient's lesion status and stent implantation and the medical effect of chemotherapy.However, since the product is not returned, it is difficult to judge as a migration or a perforation due to the product malfunction.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: the stent was placed for the patient with duodenal stenosis in the other hospital.Date unknown: chemotherapy was performed after placement of the stent.2018: the stent was found to be migrated to small intestine (it had already been more than a week) and the patient was transported to this hospital for removing it with double balloon endoscope.Date unknown: free air was already confirmed in peritoneal space in ct image and the patient was transported back to the other hospital as it was not removable.

• Brand Name: NITI-S PYLORIC & DUODENAL COVERED 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: 7521317
• MDR Text Key: 108487125
• Report Number: 3003902943-2018-00016
• 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 Model Number: DCT2412BP
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization