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	G50623
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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
Nurse opened the package and flush with water, then advanced the stent delivery system through wire guide and endoscope to bile duct desired position, during stent releasing user detected the stent cannot be deployed.User retracted the stent delivery system from endoscope and found out there is wire like material out of from the tip of delivery system.User changed to a new device with same rpn to complete the procedure."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.".
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 15-oct-2025.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot c2257812 of zilbs-635-8-8 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on (b)(6) 2025.Observations from the lab evaluation were as follows: red safety tab in place.Handle in the pre-deployment position.Kink observed below the connector cap.Distal end of retraction sheath examined - stent strut observed to be protruding through clear section of catheter.Crinkling observed along delivery system between approx.11.5cm to 30cm from the white distal tip.Device flushes with no issue.0.035 inch wire guide unable to pass beyond kink noted below the connector cap the reported failure was observed.Three attempts were made to request answers for additional information.To date no reply has been received.If a reply is received in the future, then the file will be updated accordingly.Clarification was also requested after the lab evaluation asking if it was correct to assume that the red safety tab was put back in the returned complaint device after the attempted stent deployment but no reply has been received manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label.The notes section of the instructions for use, ifu0065 which accompanies this device instructs the user to; "upon removal from package, inspect the product to ensure no damage has occurred¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0065).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.As no answers to the additional information request were shared, a possible root cause is difficult to determine but could be attributed to difficult patient anatomy.It is possible that difficult patient anatomy may have caused and/or contributed to resistance during advancement and/or attempted deployment, resulting in the kink below the connector cap observed during the lab evaluation.This kinking may have led to excessive force being applied during deployment and potentially resulting in the stent strut protruding through the clear section of catheter and crinkling on the delivery system also observed during the lab evaluation.It is also possible that if the device was bent around a tight angle in the patient¿s anatomy during attempted deployment which also may also have contributed to this occurrence.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A new device with same rpn to complete the procedure.Complaints of this nature will continue to be monitored for similar events.

• 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): COMPLAINTS.IRELAND@COOKMEDICAL.COM; 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: 23178831
• Report Number: 3001845648-2025-00499
• Device Sequence Number: 9146657
• Product Code: FGE
• UDI-Device Identifier: 10827002506234
• UDI-Public: (01)10827002506234(17)280117(30)1(10)C2257812
• 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): 10/15/2025

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: G50623
• Device Catalogue Number: ZILBS-635-8-8
• Device Lot Number: C2257812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 58 KG