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	11/22/2025
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 injected water, and ready to advance the stent delivery system through wire guide while found out the around 0.5cm of stent already out of sheath and cannot be retracted back.User retracted the device from endoscope and changed to another same rpn device 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.Can you provide the tracking information of the returned device? yes.Was the product inspected for damage before use? yes.Was the zip port facing upwards and slightly curved when backloading the wire guide? yes.Did any part of the delivery system get into the patient¿s body? no.Did the patient exhibit difficult anatomy (n/a, tortuous, altered)? (if altered please indicate the procedure type (e.G., cholodochojejunostomy)) no.Was the red safety lock intact on device before use? yes.Was the red safety lock removed before inserting the delivery system? 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) not answered.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot c2135429 of zilbs-635-10-6 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 22 december 2025.Observations from the lab evaluation were as follows; red safety tab returned in place.Device returned with stent partially deployed.Outer sheath examined and no issue observed.Delivery system examined - no issue observed.White distal tip examined - no issue observed.Stent examined and no issue observed.Device flushes with no issue.Cirl 0.035 inch wire guide passes through device with no issue.Red safety tab removed and stent deploys without issue.The reported failure was observed.Clarification was requested to confirm if during the attempt to advance the delivery system over the wire guide it was then that the stent advanced slightly.To date no reply has been received.If a reply is received in the future, then the file will be updated accordingly.It is assumed based on the complaint description and the answer to one of the additional questions where it is confirmed that the delivery system did not go into the patient¿s body that the stent advanced slightly during the attempt to advance the delivery system over the wire guide.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; "visually inspect the device with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use the device".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 could not be determined as the circumstances of use cannot be replicated in the laboratory.It is assumed based on the complaint description and the answer to one of the additional questions where it is confirmed that the delivery system did not go into the patient¿s body that the stent deployed slightly during the attempt to advance the delivery system over the wire guide.A possible root cause could be attributed to potentially a kink on the wire guide which can create resistance and irregularities in the delivery pathway, which may lead to increased forces on the delivery system.These forces can inadvertently trigger the deployment mechanism if the delivery system is advanced with excessive force.Additionally, a kink can cause uneven support or positioning of the device, increasing the risk of partial deployment or unintended release.Applying excessive or uneven force during advancement can cause a wire guide to kink or if it had pre-existing damage, such as bends, crimps, or deformities, then it is more prone to kinking during manipulation.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: the patient did not experience any adverse effects due to this occurrence.The user retracted the device and changed to a new device to complete the procedure.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 04-feb-26.

• 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: 23887660
• Report Number: 3001845648-2025-00656
• Device Sequence Number: 13167318
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)270124(10)C2135429
• 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): 02/04/2026

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: C2135429
• 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: 11/22/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 76 KG