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

Model Number DDT2012

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Perforation (2001)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

It was reported that when stent implantation, there was no complication.After 2 months later, it was confirmed perforation.Site of perforation was third to fourth portion.It was impossible to review suspected device's dhr, because it was not confirmed serial no.And it is impossible to return suspected device because stent was discarded.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.According to complaint product description, after the procedure, physician confirmed there was no sign of complications.So, it seems that cause of perforation was not device malfunction.It is considered that perforation was occurred due to patient's lesion status, after implantation.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

(b)(6) 2014 - ddt2012 was placed to a patient with duodenal stenosis.Positioning site : third portion.After the procedure, physician confirmed there was no sign of complications.(no perforation, no leakage) patient was discharged.(b)(6) 2014 - patient claimed for abdominal pain and visited hospital.Ct scan confirmed perforation and emergency operation followed.Patient recovered and discharged again.Site of peroration was third to fourth portion.Patient status: now recovered.No preoperative chemotherapy and radiotherapy 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: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; 31 9960641
• MDR Report Key: 6455687
• MDR Text Key: 71576945
• Report Number: 3003902943-2017-00015
• 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: 03/22/2017

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 Model Number: DDT2012
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR