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

Model Number	G23129
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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
The prosthesis could not be released inside the patient.It became stuck, and a broken thread is visible.When they tried to remove the prosthesis from the patient, it was not possible to deploy it was stuck, and a broken thread was visible.They then removed it and inserted a second prosthesis.Was the product inspected for damage before use? - no what was the target location? - major duodenal papilla details of the wire guide used (diameter, type, make)? - metii-35-260 was the wire guide inspected for damage before use? - n/a was the zip port facing upwards and slightly curved when backloading the wire guide? - n/a what endoscope type and channel size was used? - 4,2mm duodenoscope.Did the patient exhibit difficult anatomy? - no was the stricture dilated before stent placement? - no was an assessment carried out to determine to necessity for pre-dilation? - n/a was the safety wire removed? if yes, at what point was it removed.- no, because the problem was at the beginning of the release of the stent was resistance encountered when advancing the wire guide to the target location? - no if resistance was felt how did the physician deal with the resistance encountered? was resistance encountered when advancing the delivery system to the target location? - no if resistance was felt how did the physician deal with the resistance encountered? what was the position of the elevator during advancement? - n/a what was the position of the elevator during attempted deployment? - n/a was the directional button pressed during use? - n/a was the yellow marker kept in view during attempted deployment? - no was a stent previously placed at the same or adjacent location? (if yes, was the complaint stent placed in the stent that/was already in situ?) - no.Did any part of the stent contact the patient's anatomy when the complaint occurred? - no.Were any other defects (other than the complaint issue) observed on the device? - no.How was the procedure completed (another device, postponed for another day)? - another stent was placed.Was there any adverse effects to the patient due to this occurrence? - no.

• 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
• 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: 24668213
• Report Number: 3001845648-2026-00090
• Device Sequence Number: 5118140
• Product Code: FGE
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)271210(10)C2376229
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: D187924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C2376229
• 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: 02/16/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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 Sex: Unknown