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

Model Number CDT1810

Device Problems Break (1069); Fracture (1260)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

It was reported that the 1 years after stent placement, it was found that the patient recently complained about anemia.And the stent was found being fractured under the scope.It is hard to confirm the manufacturing history of the product because the serial number was not informed to us.Fracture 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.Colon structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status and fracture be possible.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 exactly analysis since the device was not returned and the photo was not attached.However, based on the description, which was written that "another part of the fractured stent had in-growth" and "the stool can go through but there is still a stenosis", it is considered that the stent was pressed due to pressure of patient lesion, resulted in tumor in-growth.Also, it is assumed that the stent was weakened due to the patient lesion's pressure and peristalsis of organs and so on, resulted in stent fracture.It is stated on user manual as follows.6 potential complications: tumor ingrowth, fracture.In addition, based on the description, which was written that "no damage in the patient's lesion was found after removing the fractured stent", it is not clear that the bleeding is caused by stent placement.However, it is possible to occur the bleeding by the pressure due to the tumor ingrowth on the stent, but it is hard to identify the exact cause since there is no further information and it is not known when ingrowth occurred.It is stated on user manual as follows.6 potential complications: bleeding.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

Cdt1810 was placed in transverse colon (closer to right colonic flexure) due to a stenosis caused by colonic cancer about one year ago.After that, it was going well.However, the patient recently complained about anemia and visited to the hospital (27 - 31 of oct.).The stent was found being fractured under the scope.The fractured stent on anal side (about 2cm) was removed by forceps.No damage in the patient's lesion was found after removing the fractured stent.Another part of the fractured stent had in-growth, therefore, additional stent placement is planned in the other day.The stool can go through but there is still a stenosis.The physician does not have the experience of stent fracture and was not sure the reason for the stent fracture but assumes that it has something to do with in-growth.And the physician assumes that the reason for the anemia might be the bleeding at stent placement position or colonic cancer.

• 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: 9351748
• MDR Text Key: 167353063
• Report Number: 3003902943-2019-00041
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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: 11/06/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: CDT1810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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