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

Model Number DXDT2212

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that 6 days after stent placement, leaking was found at the stenosis part during balloon dilation because of the lack of expansion.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 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.It is hard to confirm the manufacturing history of the product since the serial number was not informed to us.However, based on the description, which was written that "leaking was found at the stenosis part during balloon dilation because of the lack of expansion", it is assumed that the perforation has occurred caused by strong pressure of patient's lesion, and excessive expansion of balloon during procedure or other reason (catheter insertion process).This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

The stent was placed on 31st of oct.On 6th of nov., leaking was found at the stenosis part during balloon dilation because of the lack of expansion.Another stent (dct2012bp) was additionally placed without balloon dilation.Currently, the patient's condition is going well.The cause is not identified but the physician commented that it was not caused by the stent placement.There were no patient complications as a result of this event.

• 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, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022
• MDR Report Key: 9421357
• MDR Text Key: 169912319
• Report Number: 3003902943-2019-00045
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DXDT2212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• 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