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

Model Number DXDT2212

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that 4 months after placement of dxdt2212, in-growth occurred.Therefore, another stent was additionally placed.7 months later, both stents were found migrated.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Duodenum structure where stent was implanted is curvy.It is possible that the stent could be pressed and stent in-growth could occur by state of patient's lesion.In addition, 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.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.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 "another stent was additionally placed in stent-in-stent method due to in-growth" and "recovering the stenosis thanks to the chemotherapy could be a factor of stent migration", it is assumed that in-growth occurred on the dxdt2212 which is an uncovered stent due to the pressure of patient's lesion etc.Then after placement of another stent, stent migration occurred due to chemotherapy, condition of the patient's lesion, peristalsis of organs, foreign substances such as food and other factors complexly.In addition, there is a possibility the patient felt difficult to eat due to the stent migration, therefore it is assumed that dxdt2212 was additionally placed.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

On (b)(6) 2021: dxdt2212 was placed for the stenosis from duodenal bulb to pyloric zone caused by stomach cancer.On (b)(6) 2022: another stent was additionally placed in stent-in-stent method due to in-growth.On (b)(6) 2022: the patient was still under the chemotherapy and visited to the hospital as a periodic visit.The stents could not be found in duodenum under ct image.On (b)(6) 2022: dxdt2212 was placed as an additional treatment because eating was still difficult.The stent expansion was well soon after the stent placement and the stenosis was soft.Physician's comment: recovering the stenosis thanks to the chemotherapy could be a factor of stent migration.There were no patient complications as a result of this event.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 15367352
• MDR Text Key: 299358887
• Report Number: 3003902943-2022-00025
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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