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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that after deployment of the stent, small holes were found on the stent.It is hard to review suspected device's dhr because the serial no.Was not checked.Inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.Based on the description "physician deployed the stent and started seeing small amounts of blood in stent and that it looks like there are some small holes that allowed blood and tissue into the stent", there is a possibility the holes occurred during removal of the delivery system as the tip got caught in the stent.However, it is hard to identify the exact root cause since the device was not returned and it is hard to reconstruct the situation at the time of procedure.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)" and "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent cover breakdown".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

A patient of undisclosed gender and age underwent an unspecified procedure in which the tts esophageal stent was used.The physician deployed the stent and started seeing small amounts of blood in stent and that it looks like there are some small holes that allowed blood and tissue into the stent.

• 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, 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, 10022 ; KS 10022
• Manufacturer Contact: lee ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 16607694
• MDR Text Key: 312294906
• Report Number: 3003902943-2023-00009
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K123205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/24/2023
• 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