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

Model Number	G23813
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user attempted to perform sbs to place the stents in the hilar bile duct.He advanced two delivery systems of zilbs-635-8-10 at the target site and he pulled the handle to deploy the stent in the left bile duct first.However the stent was not deployed at all even the handle was completely pulled.The user found the handle and the cannula with the hub moved freely but the stent was still not deployed at all.He gave up on using this device for sbs and placed zilbs-635-8-8 as sis instead to complete the procedure.Lab evaluation 03 may 2022.Visual inspection: red safety lock not returned,and outer sheath is separated approx.28,5cm from the distal end.Functional inspection: device flushed with no issues, 0.035 inch wire guide passed with no issues, and stent would not deploy from the outer sheath.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k163018.Device evaluation: the zilbs-635-8-10 device of lot number c1746424 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 03 may 2022.On evaluation of the device separation was observed on the outer sheath approximately 28.5cm from the distal end.The red safety lock was not returned.The device flushed as expected and a 0.035-inch wire guide passed without issue.The stent would not deploy from the outer sheath.Document review: prior to distribution all zilbs-635-8-10 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for zilbs-635-8-10 of lot number c1746424 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current 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 c1746424.There is no evidence to suggest the user did not follow the instructions for use (ifu0065-3).The japanese packaging insert c-es1207m03 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient`s anatomy compressing the flexor making stent release difficult.It is known that the target location was the hilar bile duct.Although it is stated that the physician did not experience any resistance while advancing the device it is possible that the angle/ position of the device in the hilar bile duct could have applied pressure which could have contributed to the separation of the outer sheath.Summary: complaint is confirmed as the failure was verified in the laboratory.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
Supplemental report are being submitted due to the completion of the investigation.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 14337822
• Report Number: 3001845648-2022-00269
• Device Sequence Number: 14786621
• Product Code: FGE
• UDI-Device Identifier: 10827002238135
• UDI-Public: (01)10827002238135(17)230724(10)C1746424
• 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
• Report Date (Section B): 09/09/2022

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: 07/24/2023
• Device Model Number: G23813
• Device Catalogue Number: ZILBS-635-8-10
• Device Lot Number: C1746424
• 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: 04/11/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• 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 Sex: Unknown