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

Model Number	G50619
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
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
After they place whole device into the place and they try to deploy the device and they cannot deploy, so they change a new one.No additional details regarding patient outcome have been received to date.Currently no adverse effects to the patient have been reported.
Event or Problem Description
Supplemental report being submitted due to the investigation being completed on 09-mar-2021.After they place whole device into the place and they try to deploy the device and they cannot deploy, so they change a new one.No additional details regarding patient outcome have been received to date.Currently no adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Annex g: g04044 - device deployer.Device evaluation: the zilbs-635-6-6 device of lot number cf1697826 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.Document review: prior to distribution zilbs-635-6-6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (cf1697826) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number cf1697826.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0065-3).Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to tortious anatomy which may have compressed or rotated the delivery system as it advanced and prevented the stent from being deployed.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Device evaluation: the zilbs-635-6-6 device of lot number cf1697826 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation: n/a.Document review: prior to distribution zilbs-635-6-6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (cf1697826) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number cf1697826.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0065-3).Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to tortious anatomy which may have compressed or rotated the delivery system as it advanced and prevented the stent from being deployed.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
A supplemental report is being submitted to capture updates made to annex d and g codes on 31-oct-2024.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 10178765
• Report Number: 3001845648-2020-00361
• Device Sequence Number: 11656022
• Product Code: FGE
• UDI-Device Identifier: 10827002506197
• UDI-Public: (01)10827002506197(17)230113(10)CF1697826
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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 Expiration Date: 01/13/2023
• Device Model Number: G50619
• Device Catalogue Number: ZILBS-635-6-6
• Device Lot Number: CF1697826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020; 05/26/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 04/07/2021; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG