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

Model Number CXDT2208

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Erosion (1750)

Event Date 06/06/2023

Event Type  Injury  

Event Description

In-growth of cxdt2208 (placed one and half years ago) was found during the examination due to stomachache another stent was used to finish the procedure.The patient did not have chemotherapy.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that in-growth of cxdt2208 (placed one and half years ago) was found during the examination.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Colon 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.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, information such as photo was not provided, and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "in-growth of cxdt2208 (placed one and half years ago) was found during the examination due to stomachache", it is assumed the in-growth occurred due to patient's lesion condition, peristalsis, foreign substances and other factors complexly as the stent was pressed.The suspected device is an uncovered stent, therefore it is normal for in-growth to occur.It is assumed this caused the patient to have a stomachache.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: tumor in-growth".This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC 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, gyeonggi-do 10022
• MDR Report Key: 17234771
• MDR Text Key: 318172373
• Report Number: 3003902943-2023-00018
• Device Sequence Number: 1
• Product Code: MQR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: CXDT2208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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