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

Model Number DDT2208

Device Problems Break (1069); Fracture (1260)

Patient Problem Stenosis (2263)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, it is impossible to proceed to actual evaluation.It is, however, confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.It is hard to find out exact root cause for this complaint because it is difficult to reconstruct the situation at the time of procedure with limited information.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

On (b)(6) 2015: patient underwent stent implant procedure for pyloric stenosis caused by stomach cancer.On (b)(6) 2016: re-stenosis was doubted and this patient underwent another procedure on this date to add another stent, stent-in-stent.During the procedure, physician admitted that previously implanted (b)(4) was nearly fractured on the part positioned out of stomach.Forceps were used to cut the hanging (almost fractured) part and it was removed.Due to ingrowth, (b)(4) was added, stent-in-stent to finish the procedure.

• 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: 5832440
• MDR Text Key: 50714755
• Report Number: 3003902943-2016-00024
• 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: 07/12/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2017
• Device Model Number: DDT2208
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2014
• 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