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

Model Number CXDT2212

Device Problem Activation Failure (3270)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

The stent was placed for the stenosis at splenic flexure.However, a half of the stent from the distal edge, where the stenosis did not present, did not expand after the deployment.The physician performed the balloon dilation (dia.10mm) and the stent finally expanded.The stent was confirmed expanding more than 10mm in ct image in the next day.There were no patient complications as a result of this event.

Manufacturer Narrative

It was reported that half of the stent from the distal edge did not expand after the deployment.Based on the attached photo, it is confirmed that the end part of the stent did not 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, but it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.However, based on the non-expanded end part of the stent in the attached photo and the description "the stent was confirmed expanding more than 10mm in ct image in the next day", it is assumed that the stent expanded somewhat slowly during the procedure due to the curve and extreme pressure of the patient's lesion and other factors complexly.And then, it is considered the doctor performed balloon dilation to expand the stent.Through the user manual by taewoong, 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, 10022
• MDR Report Key: 15354254
• MDR Text Key: 303745237
• Report Number: 3003902943-2022-00024
• Device Sequence Number: 1
• Product Code: MQR
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CXDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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