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

Model Number CXDT2208

Device Problem Insufficient Information (3190)

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

Event Date 07/26/2018

Event Type  Death  

Manufacturer Narrative

It was reported that the patient was hospitalized for a colorectal cancer stage - stage iii and the stent was placed before the ileocecal valve of ascending colon.After implanting, there were no abnormalities in the patient, and the patient complained of chills at 11:00am on the (b)(6), and dead three hours later.In addition, according to the distributor's view in (b)(4), the major cause of patient death is peritonitis.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.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 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.The suspected device was successfully passed as a result of confirmation of dhr and was not removed from the patient, so it is difficult to judge perforation caused by device malfunction.In addition, based on the description, which was written that "when ct was taken after death, there was free air inside the abdominal cavity (upper abdomen) and/or neither ct nor free air or moisture storage at the stent site was recognized and the cause is unknown.", it is hard to judge perforation caused by the stent implantation.Due to the pathologic anatomy was not performed, it is impossible to know the exact cause, however, based on the description, which was written that the free air was observed in the abdominal cavity (upper abdomen), not stent implantation site, it is assumed that perforation has occurred by some other reason, and the peritonitis has occurred throughout the perforation, which was caused by unknown cause, and the patient complained chills by the peritonitis, resulted in the patient's death.The suspected device is not registered in the us and there will be continued to monitor the same or similar customer complaints.

Event Description

(b)(6) 2018: cxdt2208 was applied to the ascending colon.Stent implanted before the ileocecal valve.(b)(6) 2018: there were no abnormalities in the patient.(b)(6) 2018: am 11, the patient complained of chills.Am 14, the patient dead.Date and time unknown: when ct was taken after death, there was free air inside the abdominal cavity (upper abdomen).As no surgical measures was available, no additional measures were taken.As the patient information, the following items were confirmed.Colorectal cancer stage: stage iii with or without chemotherapy or radiotherapy: none this product was used for releasing stenosis.Physician's view there was no excretion of feces etc even after stent implanted.Also, the physician said that the patient may have had stenosis far side of the ascending colon.(toward the small intestine).Neither ct nor free air or moisture storage at the stent site was recognized and the cause is unknown.The pathologic anatomy is not scheduled.

• 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 7968329
• MDR Text Key: 123794333
• Report Number: 3003902943-2018-00025
• 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: 10/05/2018

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: 06/17/2021
• Device Model Number: CXDT2208
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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: 89 YR