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 Problems Vomiting (2144); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

It was reported that after 17 days of stent placement with clipping with another device, the stent was found being migrated.It is hard to review suspected device's dhr, because the serial no.Was not checked.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.It is difficult to identify the exact root cause because the device was not returned, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "stent was found being migrated" it is assumed stent migration occurred due to severe pressure at the patient's lesion, peristalsis of organs, foreign substances such as food, clipping with another device and other factors complexly, and it is considered this caused the patient to vomit and have feeling of abdominal pressure.After that, it is considered the stent was removed.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".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

Dct2012bp was placed in the duodenal bulb and otsc system was clipped to fix the stent to prevent the migration.After 17 days of the stent placement, the patient complained of vomit and feeling of abdominal pressure, so the patient stayed in the hospital.When checking, the stent was found being migrated, so it was removed by the small intestinal scope, and additional stent placement was performed to finish the procedure.

• 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: 12757129
• MDR Text Key: 281742924
• Report Number: 3003902943-2021-00042
• 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: 10/11/2021

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 Model Number: DCT2012BP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• 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