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U.S. Department of Health and Human Services

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

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TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT Back to Search Results
Model Number EC1810AR
Device Problems Migration or Expulsion of Device (1395); Migration (4003)
Patient Problem Erosion (1750)
Event Date 03/01/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that, approximately 5 months after stent placement, over-growth was found on the proximal side of ec1810ar above.And then, approximately 18 months, two stents were found being migrated to stomach side for about 4cm it was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Esophageal structure where stent implanted is the part with active peristalsis.It is possible that over-growth could occur by state of patient's lesion.It is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure, and the information such as photo was not provided, but based on the description, "approximately 5 months after stent placement, over-growth was found on the proximal side of ec1810ar above." it is assumed that over-growth occurred due to pressure of patient's lesion, and foreign substance such as food etc.In addition, 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, "approximately 18 months, two stents were found being migrated to stomach side for about 4cm." it is assumed that the migration has occurred due to the patient's lesion status, peristalsis of organs, and drug use.However, it is hard to exactly investigate, and analysis for this complaint since it is difficult to reconstruct the situation at the time of procedure with provided information.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: tumor over-growth, migration." 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
On (b)(6) 2018, ec1810ar was placed for esophageal cancer.On (b)(6) 2019, an over-growth was found on the proximal side of ec1810ar above, so est1808f was additionally placed there.On (b)(6) 2020, two stents (first inserted ec1810ar stent and additionally inserted est1808f stent) were recently found being migrated to stomach side for about 4cm when checking obstruction under a scope.They were not removed, and another stent (ec1812bh) was additionally placed.There were no patient complications as a result of this event.
 
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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 Key10695298
MDR Text Key214737321
Report Number3003902943-2020-00083
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
Report Date 09/21/2020
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 Expiration Date08/09/2021
Device Model NumberEC1810AR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2020
Initial Date FDA Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2018
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;
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