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

Catalog Number	ZILBS-635-10-6
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
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
During the procedure, when doctor started deploy stent & pulled the outer catheter but stent did not deployed , then he withdraw the delivery system and again tried, same thing happened again, then again withdrawn the system and check outside why it not deploying that time it opened on the table in this case doctor deployed boston stent.
Event or Problem Description
Supplemental report is being submitted as a cancellation report following the completion of the investigation on 19-may-2025, as the complaint no longer meets the description of a reportable incident.No adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ no reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.
Additional Manufacturer Narrative
Supplemental report is being submitted as a cancellation report following the completion of the investigation on 19-may-2025, as the complaint no longer meets the description of a reportable incident.No adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ no reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.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¿ and ¿the delivery system accepts a.035 inch wire guide¿.A 0.025 inch wire guide was used and the product was not inspected for kinks or damage before use.There is evidence to suggest that the customer did not follow the instructions for use in relation to inspection of the device before use and also in relation to the wire guide (ifu0065).As per section 6.6.3 of d00348426 rev007 these events will be documented in the pms log.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.Although it was said that the patient¿s anatomy was not tortuous it is possible that it may have been slightly tortuous which could have caused some resistance leading to stent deployment difficulty.As per the complaint description the user was able to deploy the stent on the table outside of the patient which would back up the assumption that the patient anatomy may have provided some resistance during the deployment process.It is also possible that if the device was bent around a tight angle in the patient¿s anatomy during attempted deployment it may also have contributed to this occurrence.Summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, no adverse effects to the patient were detailed due to this occurrence.The complaint device was replaced with another device 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
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 21217811
• Report Number: 3001845648-2025-00052
• Device Sequence Number: 15650085
• Product Code: FGE
• UDI-Device Identifier: 10827002506210
• UDI-Public: (01)10827002506210(17)261123(10)C2116653
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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-635-10-6
• Device Lot Number: C2116653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• 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 Age: 72 YR
• Patient Sex: Male