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

Model Number EC1812BH

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Internal Organ Perforation (1987); Perforation (2001)

Event Date 01/27/2015

Event Type  Death  

Event Description

On (b)(6) 2014: patient underwent total gastrectomy (roux-en-y method).On (b)(6) 2015: overgrowth admitted.Cancer invasion was severe and doctor explained the risk of perforation to patient; however, (b)(4) was implanted at proximal side of the previously implanted (b)(4) by following patient's wishes.On (b)(6) 2015: patient complained of pain.On (b)(6) 2015: ct scan revealed air leak at (b)(4) proximal side and doctor suspected a perforation.On (b)(6) 2015: patient continued to take a course of antibiotics, but the patient's condition sharply deteriorated and died on the same day.

Manufacturer Narrative

Physician's opinion: according to the doctor, patient's tissue was very fragile from cancer invasion and stent expansion is most attributable to this adverse event.Perforation from patient's condition is one of well-known side effects.For this issue, it is documented in the product's user manual.However the suspected device is not registered to us fda and it has not been shipped into us.

• Brand Name: NITI-S ESOPHAGEAL COMVI STENT
• Type of Device: ESOPHAGEAL 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: 4637637
• MDR Text Key: 5577956
• Report Number: 3003902943-2015-00012
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/09/2015

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: 04/22/2017
• Device Model Number: EC1812BH
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 02/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death