MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number	EVO-FC-20-25-10-E
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event: the trigger was jammed & hence the stent could not be deployed.Patient/event info - notes: not provided.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 23-jan-2025.
Additional Manufacturer Narrative
Device evaluation the evo-fc-20-25-10-e device of lot number cf2074502 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: it should be noted that the instructions for use (ifu0061) states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working conditions, do not use.Please notify cook for return authorization.¿ "the esophageal stent should be at least 4cm longer than the stricture, allowing for approximately 2cm longer at either end of the stricture." there is evidence to suggest that the customer did not follow the instructions for use.From the information provided, a 10cm length stent was used to treat an 8cm length stricture.From the additional questions, it is also known that the product was not inspected for kinks or damage before use, the product manager was notified to consider retraining at the facility as a precaution.As per update to the management of complaints procedure, where information is reviewed and categorized as use related/off label use and where no adverse event is identified then no complaint is required.The event is documented in the pms tracker and reviewed as part of post market surveillance.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined.A possible root cause could be attributed to tortuous patient anatomy and/or a tight stricture.It is possible that compression from a tight stricture and continued attempts to deploy may have resulted in a build-up of pressure, subsequently leading to the trigger getting jammed and preventing deployment of the stent.It is also possible that the introducer kinked during advancement, the pressure build-up of attempting to deploy with an introducer kink would have been felt through trigger resistance described by the customer and the stent would not be deployed.It is also possible that the directional button was inadvertently moved into the neutral position during attempted deployment, this could lead to the trigger jamming and prevent deployment of the stent.However, as the device was not returned for evaluation, the cause of this complaint could not be conclusively determined.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01 x used device.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation there were no adverse effect reported as a result of this occurrence.No additional procedures were required.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19631394
• Report Number: 3001845648-2024-00322
• Device Sequence Number: 7065327
• Product Code: ESW
• UDI-Device Identifier: 10827002522272
• UDI-Public: (01)10827002522272(17)250724(10)CF2074502
• Combination Product (Y/N): N
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2025
• Device Catalogue Number: EVO-FC-20-25-10-E
• Device Lot Number: CF2074502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male