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

Model Number	G23130
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As initially reported to customer relations: a 62-year-old female patient underwent a bile duct/common bile duct procedure in which the evolution biliary controlled-release stent-uncovered, g23130, was used.Once the prosthesis was recaptured to be repositioned in the bile duct, it did not deploy again, even though all the steps for its correct use were followed.Once it was out, we noticed that the prosthesis catheter was detached from its covering.Removal of the stylet was difficult once the point of no return had been passed.Assistance in procedure and prosthesis installation.Additional information received: 12-sep-2025.1.What endoscope type and channel size was used? r: duodenoscopio marca olympus, canal de trabajo de 4.2 mm.2.Details of the wire guide used (diameter, type, make)? r: guía biliar metii-35-480 cook medical (0.035¿ x 480 cm).3.Please advise the anatomical location of the intended target site.R: vía biliar.4.Were any defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.R: no.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: the device evaluation for the evo-10-11-10-b device of lot c2301637 was not returned for evaluation.With the information provided, a document-based investigation was conducted.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Photographic evidence was provided by the customer.The attachment contained 4 images which showed: image 1 ¿ a photograph of the flexor broken.Image 2 - a photograph of the stent partially deployed.Image 3 ¿ a closer photograph of the partially deployed stent.Image 4 ¿ a photograph of the devices¿ marketing box.The reported failure was observed.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c2301637 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c2301637 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0056 which accompanies this device, instructs ¿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.¿ 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: definitive root cause could not be determined.A possible root cause could be attributed to difficult patient anatomy/a tight stricture.It is possible that while being advanced or during deployment, a tortuous path or tight stricture may have caused a kink in the flexor and attempts to deploy may have led to a build-up of pressure at the kink subsequently leading to the flexor break as seen in the photographic evidence submitted with the initial report.As a result of the flexor break, the stent could not be deployed.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events summary of investigation: as initially reported a patient underwent a bile duct/common bile duct procedure in which the evolution biliary controlled-release stent-uncovered was used.Once the prosthesis was recaptured to be repositioned in the bile duct, it did not deploy again, even though all the steps for its correct use were followed.Once it was out, it was noticed that the prosthesis catheter was detached from its covering.Removal of the stylet was difficult once the point of no return had been passed.Confirmed qty, 01 used device.According to the initial reporter, the patient did not experience any adverse effects.A possible root cause could be attributed to difficult patient anatomy/a tight stricture.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 10-nov-2025.

• 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: 23144525
• Report Number: 3001845648-2025-00489
• Device Sequence Number: 21044430
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)270523(30)1(10)C2301637
• Combination Product (Y/N): N
• Initial Reporter Country: CL
• 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): 11/10/2025

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: G23130
• Device Catalogue Number: EVO-10-11-10-B
• Device Lot Number: C2301637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female