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

Model Number	G50623
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
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
Cook's wire guide awg2-35-450-a/ w4308505 could pass through the stenosed lesion in the hepatic portal region though, the zilbs- device could not.Therefore, another manufacturer's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.There have been no adverse effects to the patient reported.Physician's comment: the lesion was severely stenosed.Additional information.General questions for all complaints.(if any damages were confirmed prior to use)was the package damaged? no.(if any damages were confirmed prior to use)how was the device stored? was a sphincterotomy or balloon dilation performed prior to use of the stent device? no.Was post-dilation performed after the placement of the stent? no.What brand of endoscope was used with the device? unknown.What was the target location for the complaint device? already stated in patient/event info tab.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? already stated in patient/event info tab.Was resistance encountered when advancing the wire guide or delivery system to the target location? yes.How did the physician deal with this resistance? another device was used instead.Was the patient's anatomy tortuous? unknown.Did the tip of the delivery system cross the target location? no.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? no.Was the stent being placed through the side wall of a previously placed stent? no.Was the elevator in the down position during deployment? yes.Are images of the device of procedure available? already stated in patient/event info tab.Difficulty advancing over the wire guide: details of the wire guide used (diameter, hydrophylic, make)? already stated in patient/event info tab.Was the stent device flushed through the flushing port(s) before the procedure, as per ifu? yes.Was the patient¿s lesion heavily calcified / anatomy tortuous? unknown.
Additional Manufacturer Narrative
Pma/510(k) # k163018 device evaluation the zilbs-635-8-8 device of lot number c1783138 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review prior to distribution zilbs-635-8-8 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 manufacturing records for zilbs-635-8-8 of lot number c1783138 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 c1783138.There is no evidence to suggest the user did not follow the instructions for use (ifu0065-3).The japanese packaging insert c-es1207m06 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 from the available information.It is known that resistance was encountered by the physician while advancing to the target location, as well the patient had a severely stenosed lesion.A possible root cause could be attributed to difficult patient anatomy as it is stated that the patient had bile duct cancer in the hepatic portal region.It is possible that this resulted in the inability to advance the device through the lesion 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
Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• 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 ; 061334440
• MDR Report Key: 14346521
• Report Number: 3001845648-2022-00272
• Device Sequence Number: 5197985
• Product Code: FGE
• UDI-Device Identifier: 10827002506234
• UDI-Public: (01)10827002506234(17)231203(10)C1783138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/23/2022

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: 12/03/2023
• Device Model Number: G50623
• Device Catalogue Number: ZILBS-635-8-8
• Device Lot Number: C1783138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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