MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	ZILBS-635-10-8
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Metallic stent did not open during ercp, neither after the procedure when tried outside the patient.It was necessary to use another to complete the procedure.Patient outcome: 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.Patient/event info - notes: requested.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report submitted due to completion of investigation on 05-jun-2025.
Additional Manufacturer Narrative
Supplemental report is being submitted due to the completion of the investigation on 05-jun-2025 device evaluation 1 unit of lot c2138503 of zilbs-635-10-8 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation on 15 august 2024.Observations from the lab evaluation were as follows.Handle not deployed kink noted directly below handle severe kink/ break / fraying with metal coil exposed at approx.28cm from white distal tip severe curvature noted at 14cm to 16cm from white distal tip.Stent strut protruding approx.2cm from white distal tip.Device flushes with no issue.0.035" wire guide passes through device as intended.Unable to deploy stent.The reported failure was observed.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 or 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 for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient¿s anatomy possibly being tortuous or if the device was bent around a tight angle in the patient¿s anatomy.These could have caused some resistance during the stent deployment process which may have led to the stent perforating the outer sheath as observed in the lab evaluation.The other damage to the device observed during the lab evaluation may have been caused during the attempt to deploy the stent both inside and outside the patient and may have been further expounded during the returns process summary complaint is confirmed based on visual and/or functional inspection.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another device was used to complete the procedure.Complaints of this nature will continue to be monitored for similar event.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 20018199
• Report Number: 3001845648-2024-00484
• Device Sequence Number: 17982904
• Product Code: FGE
• UDI-Device Identifier: 10827002506241
• UDI-Public: (01)10827002506241(17)270131(10)C2138503
• Combination Product (Y/N): N
• Initial Reporter Country: PT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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 Catalogue Number: ZILBS-635-10-8
• Device Lot Number: C2138503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/05/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown