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	G50621
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
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
After inserting the zilver stent delivery system inside the cbd , while assesing the length of the stricture and stent , it was found the there is need of 8cm stent instead of 6cm.While removing the zilver 6cm stent, it got automatically deployed till half point without even removing the safety lock.Patient/event info - notes do they know why the stent got prematurely deployed during retraction? no.What endoscope channel size was used? olympus 150 series ercp scope accesory channel size 4.2mm.Details of the wire guide used (name, diameter)? visiglide.35.Did the patient exhibit difficult anatomy (n/a, tortuous, altered)? no.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? no.If additional intervention was performed, was it during the same procedure as the device failure or was it scheduled for another day? 8cm zilver deployed at same time in same procedure.

• 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 V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 25360790
• Report Number: 3001845648-2026-00212
• Device Sequence Number: 9808468
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)280702(10)C2317107
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: G50621
• Device Catalogue Number: ZILBS-635-10-6
• Device Lot Number: C2317107
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK MEDICAL SBDC-10; COOK MEDICAL SBDC-8.5; COOK MEDICAL SBDC6; OLYMPUS 150 SERIES ERCP SCOPE 4.2MM CHANNEL; OLYMPUS VISIGLIDE .35 WIRE
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 136 LB