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

Model Number CST2015F

Device Problem Activation Failure (3270)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the stent was unable to expand.Based on the attached photo, it is confirmed that the stent was partially deployed, and the deployed part did not fully expand.As a result of analysis of returned device, the outer sheath was not detached and the stent was partially deployed.The deployed part of the stent was expanded.There was curve on the stent loaded part of the outer sheath, and deployment was tried without pressure and it deployed well.In the inner sheath, notable kinking was not observed.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.Based on the non-expanded stent in the attached photo and the returned stent in the state of being expanded, it is assumed that the stent was not expanded temporarily due to the curve and strong pressure of patient's stenosis, and the removed stent did not expand temporarily even out of the patient's body due to the condition of the procedure.And then, it is assumed the stent expanded during shipment, but it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.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.

Event Description

The incident happened on (b)(6) 2022.(b)(4) with serial number mentioned above was selected for the procedure.The stent was introduced at the desired site but was unable to expand.Doctor and his team had struggled for around 10 minutes to try to make the stent fully expand and the stent did not open up.Doctor had decided to removed the entire stent and the delivery system from the patient's body.The doctor used another stent to complete the procedure.After the procedure, the stent catheter was primed with saline water, the stent are still not fully expanded.

• Brand Name: NITI-S ENTERAL COLONIC COVERED 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: 15630001
• MDR Text Key: 307069017
• Report Number: 3003902943-2022-00032
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: MY
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• Device Model Number: CST2015F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2019
• 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