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

Model Number DDT2210

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Since the suspected device was not returned and serial no.Was not identified, we could not investigate manufacturing history records.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.The suspected device is not registered in the us and we will continuously monitor whether similar or same complaint occurs.

Event Description

(b)(6) 2016: ddt2210 was applied to the 3rd portion.Later (date unknown): ingrowth was admitted and physician decided to add another stent.During the procedure to add a covered stent when physician pulled the previously placed ddt2210, it was quite loose and was easily removed out of the patient's duodenum.A new covered stent was replaced to finish the procedure.After the procedure when physician looked carefully at the removed ddt2210, physician confirmed stent mesh breakage on the anal side, a part physician did not pull when removing it out of the body.It was suspected that ddt2210 was already fractured at the end of the stent on anal side before the procedure.

Manufacturer Narrative

It was reported that after stenting, ingrowth was admitted and physician decided to add another stent.When adding covered stent, ddt2210 was removed and fracture was confirmed.As a result of analysis of returned device, fractured stent was returned.There was a lot of residue in stent.Stent was fractured at 2/3 part, and wire was connected partially.Fracture 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.According to complaint product description, it was confirmed ingrowth.So, stent might be fractured due to pressure.However, it is impossible to identify the exact root cause since it is hard to recreate the situation during insertion.It was impossible to review suspected device's dhr, so it is difficult to judge fracture by device malfunction.It is considered that after stent implantation, stent was fractured due to ingrowth and lesion status.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) 2016: ddt2210 was applied to the 3rd portion.Later (date unknown): ingrowth was admitted and physician decided to add another stent.During the procedure to add a covered stent when physician pulled the previously placed ddt2210, it was quite loose and was easily removed out of the patient's duodenum.A new covered stent was replaced to finish the procedure.After the procedure when physician looked carefully at the removed ddt2210, physician confirmed stent mesh breakage on the anal side, a part physician did not pull when removing it out of the body.It was suspected that ddt2210 was already fractured at the end of the stent on anal side before 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: park park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022 ; 19906441
• MDR Report Key: 6123608
• MDR Text Key: 60761960
• Report Number: 3003902943-2016-00043
• 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,Followup
• Report Date: 11/18/2016

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: DDT2210
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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