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

Model Number CDT1806

Device Problem Insufficient Information (3190)

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

Event Date 10/24/2015

Event Type  Death  

Manufacturer Narrative

It was reported that stent was implanted for palliative purpose and free air and perforation were discovered 2 days later from stent insertion and patient passed away with peritonitis 4 days later since then.It was confirmed that suspected device had been manufactured without significant issue and passed all the inspections.Perforation can be made with other company's device as well as ours and it is affected by patient's lesion, peristalsis of internal organs, and drug use.Colon structure where stent implanted is curvy.And the patient had a cancer with ileus.Therefore, more pressure on stent can lead a perforation.However, it is impossible to identify the exact root cause since device was not returned and it is hard to recreate the situation at the time of procedure and post-procedure.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

(b)(6) 2015: (b)(4) was applied to transverse colon for palliative purpose.(b)(6) 2015: ct scan discovered perforation and free air on stent distal side.(b)(6) 2015: patient passed away from peritonitis.No error, difficulty and/or impression of gw or scope perforating the intestinal tract were admitted during the procedure.No bleeding confirmed as well.Doctor attributes patient's death to perforation.Just for additional info, this patient also suffered from vesical cancer and hepatic metastasis.

• 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: 5312948
• MDR Text Key: 33932863
• Report Number: 3003902943-2015-00078
• 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: 08/20/2016
• Device Model Number: CDT1806
• 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: 08/21/2015
• 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: 94 YR