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

Model Number CDT1810

Device Problem Air Leak (1008)

Patient Problems Death (1802); Myocardial Infarction (1969); Stenosis (2263)

Event Date 11/07/2015

Event Type  Death  

Manufacturer Narrative

It was reported that free air was discovered on stent edge on distal side and patient passed away on the same date based on procedure description.Device was not returned since it was not removed from the patient's body.It was identified from the device history record that suspected device had been manufactured with no significant issue and passed all the inspections.Exact cause of death is unknown as autopsy was not conducted and no malfunction and/or defect related to this device were reported.In addition, it is hard to link patient's death with stent implantation since it is impossible to identify the exact root cause as it is hard to recreate the situation at the time of procedure and post procedure without device.It will be monitored whether similar adverse event occurs.Also, if any further information reported to this firm, follow-up report will be submitted.The suspected device is not registered to us fda and it has not been shipped into the us.

Event Description

On (b)(6) 2015: cdt1810 was applied to a patient with obstructive colorectal cancer (sigmoid colon stenosis) as a preoperative procedure.On (b)(6) 2015: ct scan discovered free air on stent edge on distal side.Patient passed away on the same date.When free air was admitted, doctor considered having emergency operation, but it could not be performed as myocardial infarction occurred.Exact cause of death is unknown as autopsy was not performed.(unknown if patient death was caused by perforation or mi) speaking of perforation, it is also unknown that if it was triggered by the gw or stent implantation.Reportedly, this patient had developed ileus for weeks and expansion of upper intestinal tract had been admitted as well.No information related to device malfunction or difficulty in stent implanting has been reported.Just for you info, the stenosis was so severe that stent was not at full expansion after a day.This patient was originally going to have a laparoscopic excision if the state of ileus had been improved successfully.We could not confirm whether this patient originally had a risk of mi or not.

• 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 ; 19960641
• MDR Report Key: 5313019
• MDR Text Key: 33933518
• Report Number: 3003902943-2015-00077
• 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: 12/01/2015

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 Expiration Date: 07/16/2018
• Device Model Number: CDT1810
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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: 68 YR