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

Model Number EA2012FD

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Migration (4003)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that ea2012fd (covered part) was found migrated into the stomach 8 month after placement, and was removed.After removal he observed that the uncovered part (double part) stayed in the patient.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Esophageal structure where stent implanted is the part with active peristalsis.Eaxxxxfd is manufactured as double type, and it is made of inner stent(full covered) and outer stent(uncovered).It is possible that the connection between inner stent and outer stent was weakened by food or body fluids.However, it is hard to identify the exact root cause since it is difficult to reconstruct the situation at the time of procedure, and the device was not returned.In addition, migration can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.It is difficult to identify the exact root cause because it is difficult to reconstruct the situation at the time of procedure.Based on the description, "ea2012fd (covered part) was found migrated into the stomach 8 month after placement" and "after removal he observed that the uncovered part (double part) stayed in the patient", it is considered that the connection part between inner and outer stent was weakened due to food, body fluids, etc.And was detached.After that, it is considered stent migration of the full covered inner stent occurred due to the condition of the patient's lesion, peristalsis and other elements complexly, while the uncovered outer stent stayed in the patient.Then, it is considered the inner stent was removed.Through the user manual by taewoong, it is stated that "potential complications associated with the use of the colon stent may include, but are not limited to: stent 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

Ea2012fd (covered part) was found migrated into the stomach 8 month after placement, and was removed.After removal they observed that the uncovered part (double part) stay in the patient.They positioned another esophageal stent without any problem.

• 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
• MDR Report Key: 12695813
• MDR Text Key: 282491340
• Report Number: 3003902943-2021-00040
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/19/2021

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 Expiration Date: 11/12/2022
• Device Model Number: EA2012FD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1