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

Model Number EK2418FNT2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Erosion (1750)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that stent threads broke during retrieval, 3 weeks after placement.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.However, it is hard to exactly analysis since the product was not returned yet.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.

Event Description

Urgent stent removal.Taewoong stent threads broke during retrieval and stent lodged at pharyngo-esophageal junction.Unable to retrieve safely.Insertion date (b)(6) 2021.Company informed us that the stent could be left in situ for 6 weeks.This stent removal was planned for 3 weeks with adequate safety margin.The stent ends were partially overgrown with mucosa even at this early stage and both grasping threads broke during extraction.The proximal thread of the stent snapped during the removal, distal thread of stent also snapped.The stent expanded and became lodged in the pharyngo-esophageal junction.Prompt transfer to ent surgeons at uclh for rigid laryngoscopy and stent removal close monitoring of esophagogastric stent usage in the setting of sleeve gastrectomy staple line leak, with early removal/ reposition and mdt support.

Event Description

Urgent stent removal.Taewoong stent threads broke during retrieval and stent lodged at pharyngo-esophageal junction.Unable to retrieve safely.Insertion date (b)(6) 2021.Company informed us that the stent could be left in situ for 6 weeks.This stent removal was planned for 3 weeks with adequate safety margin.The stent ends were partially overgrown with mucosa even at this early stage and both grasping threads broke during extraction.The proximal thread of the stent snapped during the removal, distal thread of stent also snapped.The stent expanded and became lodged in the pharyngo-esophageal junction.Prompt transfer to ent surgeons at uclh for rigid laryngoscopy and stent removal close monitoring of esophagogastric stent usage in the setting of sleeve gastrectomy staple line leak, with early removal/ reposition and mdt support.

Manufacturer Narrative

It was reported that stent threads broke during retrieval, 3 weeks after placement.It has been reported that the product is to be returned by distributor, but it has been updated that the product could not be returned in (b)(6) 2021.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.Ingrowth and/or overgrowth can occur on the stent according to state of patient's lesion after deployment.If removal was tried by force in this situation, it could be hard to remove due to strong resistance.It is, however, impossible to identify the exact root cause since it is hard to recreate the situation at the time of procedure.It is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure, the device was not returned, and information such as photo was not provided.However, based on the description "stent ends were partially overgrown with mucosa and both grasping threads broke during extraction", it is assumed that over-growth occurred at the stent ends due to pressure of patient's lesion and foreign substance such as food etc.After that, it is considered that the excessive tensile force was applied to the removal string when the user tried to remove the stent when the removal string was in a weakened state affected by foreign substance such as food, body fluid, etc., resulting in detachment of both removal strings.It is stated on user's manual as follows."potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: tumor over-growth" 12.Instructions for removal of niti-s full covered stents visually examine the stent for any tumor in-growth/over-growth into the stent lumen or whether the stent is occluded.If the stent lumen is clear, carefully remove using a forcep and/or snare.Grasp the retrieval string and/or collapse the proximal end of the stent then carefully retrieve the stent.If the stent cannot be easily withdrawn, do not remove the stent.Caution: do not allow excessive force to remove the stent as it may cause disconnect to the retrieval string.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

• 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
• MDR Report Key: 12558959
• MDR Text Key: 281742396
• Report Number: 3003902943-2021-00037
• 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,Followup
• Report Date: 09/17/2021

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 Date: 05/23/2024
• Device Model Number: EK2418FNT2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization