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

Model Number CDT1812

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Perforation (2001)

Event Type  Death  

Manufacturer Narrative

It was reported that there was curve severely when cdt1812 deploying, so the procedure was postponed.After 6 days, patient died.Cause of death is unknown, but suspected to be perforation.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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 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 with limited information.According to complaint product description, cause of death is unknown, and it is unknown where it perforated.So, it seems that cause of perforation was not device malfunction.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

On (b)(6) 2016: patient who had niti-s stent implanted before (exact date of placement unknown) was admitted with tumor ingrowth.Since another stenosis was found more deeply into colon near the ileocecal valve, cdt1812 was added stent-in-stent.Since fiber scope was curved severely, physician decided to remove the delivery system once to re-flush; however, strong resistance is still encountered when deployment.Another stent (cdt1810) was used to give another try, but physician struggled for bringing the delivery system beyond hepatic flexure to the lesion.Stent placement was postponed in the end.It was also reported that during the procedure, media agent leakage was confirmed from colon further down beyond stenosis.On (b)(6) 2016: patient died.Cause of death is unknown, but suspected to be perforation.(it is unknown where it perforated).

• 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: 6119653
• MDR Text Key: 60619546
• Report Number: 3003902943-2016-00041
• 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: Other
• Type of Report: Initial
• Report Date: 11/16/2016

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 Expiration Date: 12/21/2017
• Device Model Number: CDT1812
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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: 90 YR