Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT Back to Search Results
Model Number DXDT2215
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported that around 2 months after stent placement, the stent was found being fractured at 2cm away from the proximal edge.The fractured part of the stent was in the duodenal bulb.Re-stenosis was also found.Through the attached photo, it is confirmed that there are foreign materials congealed on the fractured part of the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.However, it is hard to exactly analyze because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.
 
Event Description
On (b)(6) 2021: dxdt2215 was placed in duodenum, partially sticking out into the stomach.On (b)(6) 2021: ct inspection was performed because the patient had symptoms of vomiting.Then, the stent was found being fractured at 2cm away from the proximal edge.The fractured part of the stent was in the duodenal bulb.Re-stenosis was also found.On (b)(6) 2021: the fractured part of the stent was removed under the endoscopic procedure.Enbd tube was placed for the re-stenosis.Another stent is planned to be placed additionally on (b)(6) 2021.Remaining part of the fractured stent did not migrate and still placed.On (b)(6) 2021: another stent was placed but the stenosis in sda could not be expanded sufficiently.On (b)(6) 2021: balloon dilation was performed, and it is resolved now.The physician's comment: it is not sure but the stent might be fractured because the stenosis was strong.
 
Manufacturer Narrative
It was reported that around 2 months after stent placement, the stent was found being fractured at 2cm away from the proximal edge.The fractured part of the stent was in the duodenal bulb.Re-stenosis was also found.Through the attached photo, it is confirmed that there are foreign materials congealed on the fractured part of the stent.As a result of analysis of the returned device, fractured part of the stent (around 2.5cm) was returned.Foreign substances were observed on the stent cells.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.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.Duodenum structure where stent is implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture be possible.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.However, based on the foreign substances on the stent cell of the returned device and the description "another stent was placed but the stenosis in sda could not be expanded sufficiently", it is assumed the stent was fractured due the patient lesion's strong pressure, peristalses, foreign substances and other elements complexly.In addition, after the stent fracture, it is assumed re-stenosis occurred when the stent was pressed due to the progression of the disease and strong pressure at the patient's stenosis.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent fracture, occlusion".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
(b)(6) 2021: dxdt2215 was placed in duodenum, partially sticking out into the stomach.(b)(6) 2021: ct inspection was performed because the patient had symptoms of vomiting.Then, the stent was found being fractured at 2cm away from the proximal edge.The fractured part of the stent was in the duodenal bulb.Re-stenosis was also found.(b)(6) 2021: the fractured part of the stent was removed under the endoscopic procedure.Enbd tube was placed for the re-stenosis.Another stent is planned to be placed additionally on (b)(6) 2021.Remaining part of the fractured stent did not migrate and still placed.(b)(6) 2021: another stent was placed but the stenosis in sda could not be expanded sufficiently.(b)(6) 2021: balloon dilation was performed, and it is resolved now.The physician's comment: it is not sure but the stent might be fractured because the stenosis was strong.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
lee
14, gojeong-ro
wolgot-myeon
gimpo-si, gyeonggi-do 10022
MDR Report Key12637904
MDR Text Key281991153
Report Number3003902943-2021-00038
Device Sequence Number1
Product Code MUM
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/22/2021
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 NumberDXDT2215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Initial Date Manufacturer Received 09/22/2021
Initial Date FDA Received10/15/2021
Supplement Dates Manufacturer Received09/22/2021
Supplement Dates FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-