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

Model Number CDT1810

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Perforation (2001)

Event Date 10/14/2017

Event Type  Death  

Manufacturer Narrative

It was reported that as the patient complained of abdominal bloating, so endoscopic examination was performed.Gas remained, but after that the feeling of fullness was relieved.Three days after, free air was confirmed in ct scan.The cause of free air detected in ct is not known to be an endoscopy or perforation caused by stent.The patient was then treated with colon resection and artificial anus surgery and a few days later the patient was transferred to icu due to low blood pressure and died on (b)(6) 2017.It was impossible to review suspected device's dhr, because it was not confirmed serial number.Also it is impossible to confirm whether the stent was removed from the patient according to (b)(4) distributor.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.It is, however, hard to find out whether the cause of free air was due to stent use or endoscopy because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.According to further information from a (b)(4) distributor, it was indicated that pathological dissection resulted in perforation of the tumor area but there was a possibility that the cancer tissue had invaded other organs and the tissue collapsed at the time of specimen removal and it is unknown whether the stent was the direct cause of perforation.Because of the x-ray examination, aspiration pneumonia is also recognized, and it seems to be a complex cause as a cause of death such as a blood pressure dropped, disease condition (colon cancer group 5), and transfer of tumor tissue to other organ.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

(b)(6) 2017: cdt1810 was applied to the descending colon.Stent deployment expanded well.(b)(6) 2017: as the patient complained of abdominal bloating, endoscopic examination was performed.Gas remained, but after that the feeling of fullness was relieved.(b)(6) 2017: permission for drinking.(b)(6) 2017: permission for porridge eating.(b)(6) 2017: since (b)(6), the patient continued a fever of 38 to 39 degrees, and perforation was suspected.Free air was confirmed in ct, and the physician performed emergency operation (colon resection and artificial anus surgery).After surgery, the patient was transferred to the icu due to a blood pressure dropped, and died the morning of (b)(6) at 5 am.Pathological dissection resulted in perforation of the tumor area but there was a possibility that the cancer tissue had invaded other organs and the tissue collapsed at the time of specimen removal and it is unknown whether the stent was the direct cause of perforation because of the x - ray examination, aspiration pneumonia is also recognized, and it seems to be a complex cause as a cause of death.

• 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: sanghyung park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• MDR Report Key: 7163131
• MDR Text Key: 96326447
• Report Number: 3003902943-2017-00046
• 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: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDT1810
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/03/2018
• 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): Death
• Patient Age: 82 YR