MAUDE Adverse Event Report: TAEWOONG MEDICAL CO., LTD. NITI-S PYLORIC AND DUODENAL UNCOVERED STENT; PYLORIC AND DUODENAL STENT

Model Number DDT2212

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Perforation (2001); Vomiting (2144)

Event Date 11/22/2012

Event Type  Injury  

Event Description

On (b)(6)2012, pancreatic head carcinoma and infiltration of duodenum.Ddt2212 and ddt2210 were applied.On (b)(6)2012, the pt complained of stomachache, anemia, vomiting blood (only that day), and melena (it continues still now) and was taken to the hosp.After the doctor inspected and found a perforation around the overlapping position.It was opposite of the tumor.

Manufacturer Narrative

We manage all of potential complications regarding use of stent based on clinical eval report.In the case of perforation, it was found by clinical eval, 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.This report is a retrospective report due to a fda foreign inspection warning letter.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 us fda and it has not been shipped into the us.

• Brand Name: NITI-S PYLORIC AND DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC AND DUODENAL 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: 4871929
• MDR Text Key: 6064360
• Report Number: 3003902943-2015-00049
• Device Sequence Number: 1
• Product Code: MUM
• 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: 12/13/2012

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: 08/08/2015
• Device Model Number: DDT2212
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2012
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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): Hospitalization
• Patient Age: 70 YR