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

Model Number DCT2012BP

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

It was reported dct2012bp was placed in the duodenum, and after around 1 month the stent was found to have migrated to small intestine, and surgery was performed to remove the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Migration can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Based on the procedure information "dct2012bp was found to have migrated to small intestine under ct", "causing small intestine ileus", it is supposed that migration of the implanted stent had occurred.Although it is difficult to identify the exact root cause for stent migration because the device was not returned, information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure, it is supposed that the migration had occurred due to the complex influence of the patient's lesion status, peristalsis and foreign substances.Also, it is supposed ileus occurred due to the migrated stent, but it is hard to identify the exact root cause.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent migration, stent occlusion".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) 2020: dct2012bp was placed in stent-in-stent method inside of dxdt2212 and other company's stent (dia.22mm, len.8cm).On (b)(6)2020: under ct, dct2012bp was found being migrated to small intestine, causing small intestine ileus, so an ileus tube was placed.On (b)(6)2020: the part of small intestine with the ileus and stent was excised under surgery, and bypass operation between stomach and small intestine was performed.This case is linked to a previous reported case (mdr registration number: (b)(4)).This stent migration case being reported was used on a stent that was previously reported for another case.

• 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: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 11212971
• MDR Text Key: 230936844
• Report Number: 3003902943-2021-00003
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): Y
• 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: 12/23/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: DCT2012BP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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