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

Model Number DDT2212

Device Problems Break (1069); Fracture (1260)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

It was reported that after stent implantation, it was found stent fracture.It was nearly but not completely fractured yet.Physician applied apc to cut the almost-fractured-part of stent and it was retrieved by the snare and overtube.It was impossible to review suspected device's dhr, because it was not confirmed serial no.Duodenal structure where stent was implanted is curvy.Stent can be pressured due to patient's lesion status.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, re-stenosis attributable to ingrowth was admitted.Stent might be pressured and fractured due to patient's lesion.However, it is hard to find out exact root cause for this complaint because the suspected device was not returned.Also it is difficult to reconstruct the situation at the time of procedure with limited information.Since it is impossible to review dhr, it is difficult to judge fracture by device malfunction.According to complaint product description, ingrowth caused re-stenosis.So, it is considered that stent fracture occurred due to patient's lesion.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: ddt2212 was placed to a patient with duodenal stenosis.Unknown date: re-stenosis attributable to ingrowth was admitted.Endoscopic examination followed and confirmed stent fracture near stomach.Wires came out at the proximal end and it was partly covered by food residue.Fractured part was roughly 1/3 of the proximal end.It was nearly but not completely fractured yet.Physician applied apc to cut the almost-fractured-part of stent and it was retrieved by the snare and overtube.Another stent (covered type) was added on the proximal side for the re-stenosis by the ingrowth.Patient status: now recovered.

• 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, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; 31 9960641
• MDR Report Key: 6448761
• MDR Text Key: 71323291
• Report Number: 3003902943-2017-00012
• 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: 03/21/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DDT2212
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 03/31/2017
• 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