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

Model Number	G50624
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: zip code, postal code: (b)(6).
Event or Problem Description
As initially reported to customer relations: a patient of undisclosed gender and age underwent an unspecified procedure in which the zilver 635 biliary self expanding metal stent, g50624, was used.While customer was deploying the stent when they got to the end of the stent deployment, they heard a pop.The stent had deployed; however, the outer catheter had broken off and was hanging outside the papilla still.The customer had to use a rat tooth forceps to remove the outer catheter from the patient.Per cir, the following triage questions were sent to the district manager on 18apr2025, and reply received on 21apr2025.What was the target location of the stent? the right heptic duct.Details of the wire guide used (name, diameter)?.035, jagwire.Did the patient exhibit difficult anatomy (n/a, tortuous, altered)? (if altered please indicate the procedure type (e.G., cholodochojejunostomy) no.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? (if yes, please specify what additional defect(s) were observed and where on the device this was observed) no.What was the position of the elevator during deployment? elevator was lowered.Was there resistance felt passing the delivery system through the stricture? no.Was the stent being placed through the side wall of a previously placed stent? no.Did any part of the product snag/get caught on the stent when removing the delivery system? no.Was the stent deployed in the correct position"? yes.

• 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 MEDICAL IRELAND; o'halloran rd; national technology park; limerick
• MDR Report Key: 22018848
• Report Number: 3005580113-2025-00029
• Device Sequence Number: 9484322
• Product Code: FGE
• UDI-Device Identifier: 10827002506241
• UDI-Public: (01)10827002506241(17)271120(10)C2238996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2025
• Report Date (Section F): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G50624
• Device Catalogue Number: ZILBS-635-10-8
• Device Lot Number: C2238996
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/09/2025