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

Model Number DCT2008BA

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that only the anal side stent was found to be migrated to mouth side about 2cm by imaging.It was decided to keep monitoring continuously.Re-placement of stent was not done because the curve was strong.It was impossible to review suspected device's dhr, because it was not confirmed serial no.And it is impossible to return to us, suspected device because stent is still in patient's body.Migration 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.Based on the description, which was written that "the curve was strong", it is assumed that the migration has occurred due to the patient's lesion status, however, 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 with limited information.The suspected device is not registered in the us and "there" will be continued to monitor the same or similar customer complaints.

Event Description

On (b)(6) 2018: two stents (mouth side: dct2010ba, and anal side: dct2008ba) were placed as stent-in-stent.On (b)(6) 2018: only the anal side stent was found to be migrated to mouth side about 2cm by imaging.It was decided to keep monitoring continuously.Re-placement of stent was not done because the curve was strong.There were no patient complications as a result of this event.

• Brand Name: NITI-S PYLORIC & DUODENAL COVERED 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
• MDR Report Key: 7968330
• MDR Text Key: 123798566
• Report Number: 3003902943-2018-00024
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCT2008BA
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• 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