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

Model Number	G50622
Medical Device Problem Code	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	07/20/2020
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.
Event or Problem Description
Supplemental report being submitted due to the investigation being completed on 16-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.
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Annex g: g04044 - device deployer.Device evaluation: the zilbs-635-6-8 device of lot number c1520365 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-635-6-8 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 (c1520365) 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 c1520365.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 tortuous 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.

• 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
• MDR Report Key: 10417662
• Report Number: 3001845648-2020-00504
• Device Sequence Number: 2942730
• Product Code: FGE
• UDI-Device Identifier: 10827002506227
• UDI-Public: (01)10827002506227(17)210718(10)C1520365
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 07/18/2021
• Device Model Number: G50622
• Device Catalogue Number: ZILBS-635-6-8
• Device Lot Number: C1520365
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 60