MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G23128
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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 the prosthesis was opened, it was broken.: the opening was empty and the gun did not activate the mechanism correctly.
Event or Problem Description
A combined correction complete mdr is scheduled to update imdrf codes after completion of investigation on 06-nov-2025.
Additional Manufacturer Narrative
Device evaluation the evo-10-11-6-b device of lot number c2317877 involved in this complaint was returned for evaluation, with its opened original packaging.With the information provided, a physical examination and document-based investigation was conducted.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device, the following was observed: visual inspection: ¿ stent returned partially deployed.¿ directional button in deploy position.¿ red marker on the 08th dimple.¿ intoducer kinked measuring appox.116cm and 122cm from the white tip.Functional inspection: ¿ handle actuating with resistance for deployment and recapture and unable to deploy the stent.¿ handle opened all the inner components are intact.The reported failure was observed.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.As per (b)(4) rev008 - final qc instruction for evolution biliary device (uc) - step 1.7 ¿inspect for visual defects; i.E.Loose or embedded foreign materials, rough or sharp edges, kinks.¿ 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 user.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.Given that the packaging was opened on return, a possible root cause for the issue reported could be attributed to transportation, storage facilities or handling of the packaging after the device left the manufacturing facility.Multiple inspections are in place for the device during the manufacturing, quality control and packaging process therefore it is highly unlikely this occurred prior to leaving cook ireland.A possible root cause could be attributed to impact or excessive pressure that may have been placed on the packaged device during transportation or storage.It is possible that this pressure or impact may have caused the introducer to kink as seen in the lab evaluation.It is also possible that the kinks occurred when removing the device from the packaging, from the additional questions, the damage occurred when unpacking or preparing the evolution.It should be noted that the stent was returned partially deployed, from the event description the nurse attempted to deploy the stent but it was not working correctly, this was likely due to the kinks.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01 x prior to use device.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation according to the initial reporter, when the evo-10-11-6-b was opened, it was broken.This event occurred prior to patient contact.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23151808
• Report Number: 3001845648-2025-00491
• Device Sequence Number: 20128265
• Product Code: FGE
• UDI-Device Identifier: 10827002231280
• UDI-Public: (01)10827002231280(17)270704(30)1(10)C2317877
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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 Model Number: G23128
• Device Catalogue Number: EVO-10-11-6-B
• Device Lot Number: C2317877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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 Sex: Unknown