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

Model Number CDP2207BP

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that the stent mesh did not fully expand because the stent mesh was entangled.Another stent.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that the stent did not fully expand.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Our nitinol wire, the raw material of stent, is shape-memory alloy.Generally, if the stenosis of a patient's lesion is severe, the stent expansion may require some time.However, it is difficult to identify the exact root cause because it is difficult 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 "the stent did not fully expand", it is assumed that the stent was not expanded temporarily due to the condition of the patient's lesion and other elements complexly.Through the user manual by taewoong, it is stated that it is stated that "a stent may require up to 1 to 3 days to expand fully and balloon dilatation inside the stent can be performed if the physician deems necessary".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: 18993879
• MDR Text Key: 339331778
• Report Number: 3003902943-2024-00010
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDP2207BP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2021
• 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