MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G23815
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 zilbs-635-10-10 was advanced via the papilla toward the hilar bile duct; however, it was unable to cross the stricture.A non-cook stent was placed to complete the procedure.Additional information provided by the sales rep on 26feb2026: was there any evidence that the sheath/catheter being kinked when the delivery system was removed from the patient? no.What endoscope channel size was used? 3.7mm (olympus, jf-260v).Details of the wire guide used (name, diameter)? already provided in other non-cook products (fielder 025, 025inch gw).Did the patient exhibit difficult anatomy? no.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? no.Was the delivery system tracked around a tight angle in the patient anatomy or around a tight angle in an endoscope? none other than the reported stricture.Was resistance encountered when advancing the delivery system to the target location? no resistance was encountered until the reported stricture.If resistance was felt how did the physician deal with the resistance encountered? na.What was the position of the elevator during advancement? it was set to off.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• 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
• 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: 24673192
• Report Number: 3001845648-2026-00096
• Device Sequence Number: 13287247
• Product Code: FGE
• UDI-Device Identifier: 10827002238159
• UDI-Public: (01)10827002238159(17)280127(10)C2259816
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K163018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: G23815
• Device Catalogue Number: ZILBS-635-10-10
• Device Lot Number: C2259816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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