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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 EST2010F
Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
The stent was broken when they trying to deploy it.It broke on the user end and not in the patient.They were not able to advance it anymore.They removed it from the scope and the patient manually.The procedure was successfully completed with another device of the same type (different lot).
 
Manufacturer Narrative
It was reported that the delivery system was broken during deployment.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
The stent was broken when they trying to deploy it.It broke on the user end and not in the patient.They were not able to advance it anymore.They removed it from the scope and the patient manually.The procedure was successfully completed with another device of the same type (different lot).
 
Manufacturer Narrative
It was reported that the stent was broken when they trying to deploy it.As a result of analysis of returned device, the outer sheath was detached and stent was deployed and returned with the delivery system.There was curve on the stent loaded part of the outer sheath.In the inner sheath, curve was observed, but notable kinking was not.Resistance can be felt due to pressure generated by patient's lesion during deployment.It can cause deployment failure if deployment is tried by force in this situation since outer sheath can be stretched and detached.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.Based on the detached outer sheath and curve on the stent loaded part, it is considered that delivery system was pressured due to patient's lesion during the procedure and deployment was tried in that situation.It was hard to deploy due to pressure/curved sheath, in which concentrated the force causing strong resistance and the outer sheath was detached in the end, resulting in deployment failure.In addition, based on the stent being returned deployed, it is considered that the deployment test was tried outside of the patient's body after removing the delivery system, resulting in success.This complaint is assumed that it was a malfunction of the device due to the pressure of the patient's lesion, there will be continued monitoring of the same or similar customer complaints.
 
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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 Key16793199
MDR Text Key314270577
Report Number3003902943-2023-00011
Device Sequence Number1
Product Code ESW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K123205
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 04/13/2023
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 NumberEST2010F
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 04/13/2022
Initial Date FDA Received04/24/2023
Supplement Dates Manufacturer Received04/13/2022
Supplement Dates FDA Received06/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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