MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD NITI-S ESOPHAGEAL STENT; ESOPHAEAL STENT

Model Number EST1808F

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 02/26/2014

Event Type  Death  

Event Description

(b)(6) 2013: an esophageal stent (cook evolution esophageal stent 18mm x 10cm) was applied to middle and lower esophagus due to esophageal cancer.(b)(6) 2014: after two months from the first stent implantation, tumor overgrowth was admitted at the lower end of the stent.Niti-s stent (est1808f) was implanted in 2-3cm below the lower end of the first stent, anatomically just above the egj.Procedure went successfully.The pt condition was reported to be good; the pt could go back to work and eat without a problem.(b)(6) 2014 at 20:00: the pt's condition sharply deteriorated, vomited blood and was urgently transported to the hospital.As a result of ct scan, the pt was diagnosed as having an aortoenteric fistula.Blood transfusion as performed to the pt.(b)(6) 2014 at 00:54: the pt again vomited blood and died from aortic perforation.

Manufacturer Narrative

The findings in an autopsy admitted the ulcer formation in the lower stent end (it is unk which stent lower ends was perforated), which has been perforated the aorta.The perforated area was not a site of tumor; however, the tissue of the perforated area could have been very fragile due to radiation therapy performed in the past.(no specific into available on the radiation therapy) several congestion lines were also admitted on the esophageal wall, but it remains unk where exactly these congestion lines formed in the implanted two stents.We check device history record for the suspect device.There was no significant to report.The suspect device was discarded at user facility.So, we cannot proceed further investigation.Medical opinions: no word as to whether niti-s stent is attributable to the pt death or not; however, it seems like stent shorting (niti-s) occurred given that the niti-s stent originally implanted just 2-3 cm below the lower end (out of) of the first stent was found to be only 1cm.

• Brand Name: NITI-S ESOPHAGEAL STENT
• Type of Device: ESOPHAEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO., LTD; 14, gojeong-ro, wologot-myeon; gipo-si; gyeonggi-do 415-8 73; KS 415-873
• Manufacturer Contact: 14, gojeong-ro, wolgot-myeon, gimpo-si; gyeonggi-do ; 19040641
• MDR Report Key: 4133290
• MDR Text Key: 4936676
• Report Number: 3003902943-2014-00002
• Device Sequence Number: 1
• Product Code: ESW
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: EST1808F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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
• Treatment: COOK EVOLUTION ESOPHAGEAL STENT 18MM X 10CM
• Patient Outcome(s): Death
• Patient Age: 44 YR
• Patient Weight: 57