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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2020
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
While deploying the zilver stent in the left hepatic duct, the physician mentioned that the markers under fluoroscopy were not obvious and may have contributed to him deploying the stent slightly higher than anticipated.He does not want to make a complaint but felt the lack of visibility of the stent was a contributing factor to the stent being deployed too high.While deploying the zilver stent yesterday, the physician mentioned that the markers under fluoroscopy were not obvious and may have contributed to him deploying the stent slightly higher than anticipated.Additional info received 12-may-2020: the physician managed to reposition the stent just after deployment by manipulating in with spybite forceps during that procedure.Additional file created to capture user error as this device should not be moved once placed.
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Device evaluation: the zilbs-635-8-10 device of lot number cr1617396 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-635-8-10 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 (cr1617396) revealed no discrepancies that could have contributed to this complaint.There is evidence to suggest the user did not follow the ifu(ifu0125-0)."these metal biliary stents are not intended to be repositioned or removed after deployment in the bile duct".It was also noted that the patient anatomy was tortuous.Root cause review: a definitive root cause of user error was identified from the available information.The physician repositioned the stent after deployment.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
While deploying the zilver stent in the left hepatic duct, the physician mentioned that the markers under fluoroscopy were not obvious and may have contributed to him deploying the stent slightly higher than anticipated.He does not want to make a complaint but felt the lack of visibility of the stent was a contributing factor to the stent being deployed too high.While deploying the zilver stent yesterday, the physician mentioned that the markers under fluoroscopy were not obvious and may have contributed to him deploying the stent slightly higher than anticipated.Additional info received 12-may-2020: the physician managed to reposition the stent just after deployment by manipulating in with spybite forceps during that procedure.Additional file created to capture user error as this device should not be moved once placed.

• 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: 10131998
• Report Number: 3001845648-2020-00342
• Device Sequence Number: 2911533
• Product Code: FGE
• UDI-Device Identifier: 10827002238135
• UDI-Public: (01)10827002238135(17)211016(10)CR1617396
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 10/16/2021
• Device Model Number: G23813
• Device Catalogue Number: ZILBS-635-8-10
• Device Lot Number: CR1617396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1