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

Model Number CXDT2212

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

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

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the stent did not expand partially during the procedure.3 days after placement, the stent was found being migrated, and after removal, the stent was found to be fully expanded.Based on the attached photo it is confirmed that the distal part of the stent was not expanded temporarily right after placement.It was confirmed from the device history record that device had been manufactured with no significant issues 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 distal side of stent did not expand even though that part was not on the stenosis part" and the temporarily not expanded distal part of the stent right after placement in the attached photo, it is assumed the stent did not expand temporarily due to the environment at the time of procedure.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.It is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.However, based on the description "3 days after the stent placement, the stent was migrated to the anal side" and "the stent was fully expanded at the non-stenosis part", it is assumed stent migration occurred due to the partially not expanded stent, severe pressure at the patient's lesion, peristalsis of organs, foreign substances such as food and other factors complexly.Then, it is assumed the stent expanded during migration, and was removed.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" and "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 u.S.But we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

When deploying the stent, the distal side of stent did not expand even though that part was not on the stenosis part.The physician expected that the stent would expand later, so the stent was placed.A while later, the stent was found not expanding but the physician determined to monitor, and the procedure was finished.3 days after the stent placement, the stent was migrated to the anal side and the stent was fully expanding under x-ray image.The surgery was originally planned 2 weeks after the stent placement bit it was performed earlier ((b)(6) 2021) due to the event above.During the surgery, the stent was fully expanded at the non-stenosis part.The stent was removed and the surgery was finished.There were no patient complications as a result of this event.

• 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, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 13149220
• MDR Text Key: 288482345
• Report Number: 3003902943-2022-00001
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K123205
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CXDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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