MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23129
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
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
When trying to use the metal prosthesis, it was found that it was not possible to fire the prosthesis.Patient outcome: na.
Additional Manufacturer Narrative
Device evaluation the evo-10-11-8-b device of lot number c2082422 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 (ifu0056) states the following: ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined.With the limited information provided, a possible root cause could be attributed to tortuous patient anatomy and/or a tight stricture, which may have resulted in a build-up of pressure causing the introducer to kink leading to the deployment difficulties reported.A second possible root cause could be that the build-up of pressure caused the sheath tube to separate from shuttle cap which would have also led to the deployment issue reported by the customer.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Multiple attempts were made to gain more information regarding this event however no new information was received confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation the evo-10-11-8-b device of lot number c2082422 involved in this complaint was not returned for evaluation.Confirmed quantity of 01 x used device.There were no adverse events reported as a result of this occurrence.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 03-jul-25.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 20610488
• Report Number: 3001845648-2024-00642
• Device Sequence Number: 7411301
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)250818(10)C2082422
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121430
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 08/18/2025
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C2082422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2024
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male