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

Model Number CD2808

Device Problems Fracture (1260); Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

It was reported that the stent was 30% released in the packaging, and free wires of stent penetrated into the mucous membrane.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.But there is additional information about the relevant device such as a picture, and suspected device is not returned yet.Also, it is impossible to identify the exact root cause because it is hard to recreate the situation at the time of procedure.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.

Event Description

Stent was 30% released from the tubus in the packaging.The stent was placed with x-ray control in the region of the stenosis.In the endoscopic examination, the wire structure of the stent was defective, in which free wires penetrated into the mucous membrane.They removed the stent from the patient.

Manufacturer Narrative

It was reported that the stent was 30% released in the packaging, and free wires of stent penetrated into the mucous membrane.As a result of analysis of returned device, it was hard to confirm of the pre-deployment due to the product was used for patient after occurring pre-deployed.It was found that a part of stent is fractured.Two things can be inferred from the cause of fracture.The first one is that the fracture occurred on the proximal side of the stent, the stent would have fractured caused by using the removal tool when the stent was removed the stent.The other is that the fracture occurred on the distal side of the stent, the stent would have fractured due to the user reloaded the stent on delivery system for using this on procedure.However, taewoong medical do not allow users to reload the stent with the user manual.Also it is described on the user manual by this firm that 9.Instruction in the event of damage warning: visually inspect the system for any sigh of damage.Do not use if the system has any visible signs of damage.Failure to observe this precaution may result in patient injury.However, according to the report, wires penetrated into the mucous membrane, which can assume the second cause is the main cause.Locking system is checked on 1st stent loading inspection and 2nd half-finished product inspection prior to packaging.This device is sealed in the sterilized package and packaged in the 1st individual box and 6 pcs of individual box are packaged in the 2nd big carton.Pre-deployment can occur by pusher due to strong impact during transportation and /or storage.Fracture can be occurred by other company's device as well as ours.It is affected by process of procedure, patient's lesion status, peristalsis of organs, and drug use in general.According to description, it was reported that the user used the pre-deployed stent.Thus, stent was influenced because of reloading, so the stent was fractured.However, it is hard to find out exact root cause for this complaint because it is difficult to reconstruct the situation at the time of procedure.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.According to description, the free wires penetrated into the mucous membrane in the endoscopic examination, so it was considered that perforation may have occurred because user did not check stent fracture and inserted into the patient.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, it is impossible to identify the exact root cause because it is hard to recreate the situation at the time of procedure.Taewoong asked to (b)(4) distributor why the surgeon used pre-deployed stents, and how the surgeon operated this pre-deployed stent, inserted to patient's lumen for obtaining additional information, but it was hard to do.According to device history records, there was no problem with that device.So it is difficult to judge fracture by device malfunction.It is considered that stent was fractured due to insufficiency of aware concerned about instruction in the event of damage, after that the user used of this fractured stent to the patient, the stent was penetrated into the mucous membrane in the end.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

Stent was 30% released from the tubus in the packaging.The stent was placed with x-ray control in the region of the stenosis.In the endoscopic examination, the wire structure of the stent was defective, in which free wires penetrated into the mucous membrane.They removed the stent from the patient.

• 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 6889440
• MDR Text Key: 87210693
• Report Number: 3003902943-2017-00033
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: CD2808
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/24/2017
• Supplement Dates Manufacturer Received: 09/08/2017
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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
• Patient Age: 84 YR