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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
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
Last week the team used an uncovered stent.The stent was deployed (not fully) but wasn't in the correct position so needed to be altered, however when the team attempted to re-sheath it, it unfortunately would not retract fully.The stent had not been deployed beyond the point of no return at any stage.As the stent could not be fully re sheathed, it had to be completely removed, and a different stent was used instead.I¿ve attached a photo showing the end of the stent for reference.What was the target location? right hepatic details of the wire guide used (diameter, type, make)? acrobat was the zip port facing upwards and slightly curved when backloading the wire guide? no what endoscope type and channel size was used? olympus did the patient exhibit difficult anatomy (n/a, tortuous, altered)? wire passed without difficulty if altered please indicate the procedure type (e.G., cholodochojejunostomy) no; standard anatomy what was the length and diameter of the stricture? perihilar 2cm was the stricture dilated before stent placement? no was an assessment carried out to determine the necessity of pre-dilation? almost never predilate was the safety wire removed? if yes, at what point was it removed? no was an assessment carried out to determine the necessity of pre-dilation? almost never predilate was the safety wire removed? if yes, at what point was it removed.No was resistance encountered when advancing the delivery system to the target location? (if resistance was felt how did the physician deal with the resistance encountered? yes, but minimal.Was the yellow marker kept in view during attempted deployment? yes 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?) 1st stent.

• 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: 24965765
• Report Number: 3001845648-2026-00157
• Device Sequence Number: 10496122
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)270116(10)C2257111
• Combination Product (Y/N): N
• 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): 06/03/2026

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: G23130
• Device Catalogue Number: EVO-10-11-10-B
• Device Lot Number: C2257111
• 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: 04/01/2026
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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