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

Model Number CDT2208

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Perforation (2001); Peritonitis (2252)

Event Date 07/31/2015

Event Type  Death  

Manufacturer Narrative

We manage all of potential complications regarding use of stent based on clinical evaluation report.In the case of perforation, it was found by clinical evaluation, and the risk of this complication is controlled by risk management report.It was confirmed by reviewing the device history record of the device that there was nothing significant, that it was manufactured normally.We are monitoring such complications continuously.And if any further info reported to this firm, follow-up report will be submitted.Perforation from patient's condition is one of well-known side effect.For this issue, it is documented in the product's user manual.However the suspected device is not registered to united states fda and it has not been shipped into united states.

Event Description

On (b)(6) 2015: patient with obstructive colorectal cancer was transferred to this hospital.On (b)(6) 2015 at 17:30: cdt2208 was implanted for preoperative decompression purpose.No problem was admitted during and right after implantation.(no extra-intestinal leakage admitted when injected contrast agent).On (b)(6) 2015 at 21:00: patient suffered cardiopulmonary arrest.On (b)(6) 2015 at 4:00: died from generalized peritonitis.Reportedly, neither chemotherapy nor radiation therapy was performed before this patient was transferred to this hospital.Physician commented that perforation is most likely attributable to the pt's death, but given that stent itself was at full expansion and there was no contrast agent leakage, perforation at other site (other than where stent has been implanted) might be the cause of this adverse event, morbid anatomy is performed at the moment, but the exact cause of this incident may not be confirmed after half a year when the result is expected to be come out.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; gimpo-si, gyeonggi-do ; KS
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon; gimpo-si, gyeonggi-do 415-8-73 ; 19960641
• MDR Report Key: 5048852
• MDR Text Key: 24886175
• Report Number: 3003902943-2015-00064
• 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: Not Applicable
• Report Date: 08/17/2015

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: 06/15/2018
• Device Model Number: CDT2208
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 84 YR