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	G50620
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
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 the nurse opened the package and flushed the system with sterile water, the zilbs-635-8-6 stent delivery system was advanced over the guidewire through the duodenoscope and positioned in the common bile duct.When the operator attempted to deploy the stent, the pusher could not be advanced and the stent would not release.The assembly was withdrawn from the scope, and a kink was observed at the distal (leading) tip.A new device of the same rpn was introduced, and the procedure was completed without further issues."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." what endoscope channel size was used? 3.7.Details of the wire guide used (name, diameter)? metii-35-480.Did the patient exhibit difficult anatomy (n/a, tortuous, altered)? (if altered please indicate the procedure type (e.G., cholodochojejunostomy).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, balloon dilation.Was a stent previously placed at the same or adjacent location? no.Was the stent being placed through the side wall of a previously placed stent? no.What was the position of the elevator during advancement/deployment/removal? down.

• 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 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: 24715287
• Report Number: 3001845648-2026-00107
• Device Sequence Number: 5763632
• Product Code: FGE
• UDI-Device Identifier: 10827002506203
• UDI-Public: (01)10827002506203(17)280418(10)C2289365
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: G50620
• Device Catalogue Number: ZILBS-635-8-6
• Device Lot Number: C2289365
• 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: 02/28/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 48 KG