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

Model Number CDT2815

Device Problems Activation, Positioning or Separation Problem (2906); Insufficient Information (3190); Activation Failure (3270); Activation Problem (4042)

Patient Problem Perforation (2001)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that failed to deploy.Caused perforation at rectum.As a result of analysis of returned device, outer sheath was detached and stent was loaded.There is curve on the stent loaded part, and deployment was tried without pressure, but, very strong resistance occurred, resulting in deployment fail.It has been deployed by the hand, holding the tip, and pulled out by force.In the inner sheath, the curve was observed, but, the notable kinking was not.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 can be hard to deploy due to pressure generated by patient's bended lesion.In addition, that device is 220¿22.0 cm long as its usable length so it can be hard to deliver the force during deployment.Outer sheath can be stretched and detached so it can cause deployment failure if deployment was tried by force in this situation.However, 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 deployment failure under no pressure, the detached outer sheath and curve on the stent loaded part, it is considered that delivery system was pressured due to patient's lesion during procedure and deployment was tried in that situation.It was hard to deploy due to pressure/curved sheath, in which concentrated the force, and strong resistance occurred and the outer sheath was detached in the end, resulting in deployment failure.In addition, based on the returned stent in state of loading on the delivery system, it is possible to occur the perforation on the patient's rectum during the procedure due to guide wire, scope, delivery system etc.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 hard to know whether using the scope etc, and the additional description has not been updated.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: perforation" 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

Failed to deploy.Caused perforation at rectum.

• 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: 11839571
• MDR Text Key: 251467649
• Report Number: 3003902943-2021-00018
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): Y
• Reporter Country Code: ID
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: CDT2815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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