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

Model Number DDT2206

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Inflammation (1932)

Event Date 10/27/2015

Event Type  Death  

Manufacturer Narrative

It was reported that onset of pancreatitis and cholangitis were recognized after stent insertion and patient died 6 days later since implantation of stent based on procedure description.Device was not returned since it was not removed from the patient's body.As a result of confirmation of device history record for this device, there was nothing special identified and it passed, successfully, the criteria of manufacturing and inspection.Exact cause of death is unknown as autopsy was not conducted and no obvious malfunction and/or defect was reported.In addition, it is hard to explain the link between patient's death and stent insertion as it is impossible to identify the exact root cause without device and it is hard to recreate the situation at the time of procedure and post-procedure.It will be monitored for the similar adverse event reported.The suspected device is not registered to us fda and it has not been shipped into the u.S.

Event Description

On (b)(6) 2015: ddt2210 was implanted to a patient with duodenal stenosis from metastasis.Since it was not enough to cover the whole length, ddt2206 was added.On (b)(6) 2015: next day onset of severe pancreatitis was recognized.Date unknown: onset of cholangitis was recognized.On (b)(6) 2015: patient died.No obvious malfunction/defect has been reported.As a treatment right after the onset of pancreatitis, doctor attempted to implant pancreatic duct stent endoscopically, but location of the duodenal papilla could not be confirmed as ingrowth of tumor was severe.As a result, pancreatic duct stent could not be implanted.Exact cause of death is unknown as autopsy was not performed.

• Brand Name: NITI-S PYLORIC & DUODENAL UNCOVERED STENT
• Type of Device: PYLORIC & DUODENAL 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: 5305346
• MDR Text Key: 33699070
• Report Number: 3003902943-2015-00076
• 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: 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: 07/22/2018
• Device Model Number: DDT2206
• 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: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• 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: 79 YR