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 ESOPHAGEAL COVERED STENT; ESOPHAGEAL 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 ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT Back to Search Results
Model Number EC1808AR
Device Problems Migration or Expulsion of Device (1395); Migration (4003)
Patient Problem Cough (4457)
Event Date 06/30/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that after stent placement, the patient coughed during removal of delivery system, and then the placed stent was moved.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
Ec1808ar was used for the 3cm stenosis in lower esophagus, right above the junction.After the successful stent placement, the patient coughed intensely during removal of delivery system, and then the placed stent was moved towards the proximal side.Another stent (niti-s) was used to finish the procedure.There were no patient complications as a result of this event.
 
Event Description
Ec1808ar was used for the 3cm stenosis in lower esophagus, right above the junction.After the successful stent placement, the patient coughed intensely during removal of delivery system, and then the placed stent was moved towards the proximal side.Another stent (niti-s) was used to finish the procedure.There were no patient complications as a result of this event.
 
Manufacturer Narrative
It was reported that after the successful stent placement, the patient coughed intensely during removal of delivery system, and then the placed stent was moved.As a result of analysis of returned device, stent was deployed, and was returned with the delivery system.The y-connector was pulled back halfway.There were no curve and kinking on the stent loaded part of the outer sheath, and the skirt was folded.In the inner sheath, kinking was observed but it is not clear if it occurred during transit or procedure.Blood and/or body fluid were hardened on the skirt, but it was successfully spread open to its original state.It was confirmed from the device history record that device had been manufactured with no significant issues and passed all the inspections successfully.Based on the skirt of the stent being folded, y-connector being pulled back halfway and the description, it is assumed when the delivery system was removed, the inner sheath was not positioned back to its original position into the outer sheath and removal was tried.The tip got caught in the skirt and the patient coughed, causing the stent to be moved during removal of the delivery system.Taewoong's user manual of this device states the following."after stent deployment, removal of the introducer system and guide wire from the patient should be handled with care.During removal, if strong resistance is felt, wait 3~5 minutes for the stent to expand then try again.(position the inner sheath to its original position into the outer sheath before removal)" this suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NITI-S ESOPHAGEAL COVERED STENT
Type of Device
ESOPHAGEAL 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 Key15071336
MDR Text Key296288160
Report Number3003902943-2022-00019
Device Sequence Number1
Product Code ESW
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 07/01/2022
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? No
Device Operator Health Professional
Device Model NumberEC1808AR
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 07/01/2022
Initial Date FDA Received07/21/2022
Supplement Dates Manufacturer Received07/01/2022
Supplement Dates FDA Received11/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
-
-