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 Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
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
The stent did not deploy the proximal end of the stent was deviated and broke the sheet."as per complaint form": klatskin tumer type iv, dr.Could introduce one wire guide in each hepatic duct, two zilver were introduced (as written in ifu) and at the time of deployment one of the zilver didn't deploy and they have to pull it out, loosing the possibility to drain that hepatic duct.Product shows one of the gold crown of the stent itself went through the coil sheath.
Event or Problem Description
Confirmation received from quality: "there was no fracture noted by the engineers in the lab.This complaint can be cancelled as the inability to deploy the stent would have resulted from the stent strut protruding from the sheath".All malfuctions have been captured under (b)(4).This report is being submitted as a cancellation report.
Additional Manufacturer Narrative
Confirmation received from quality: "there was no fracture noted by the engineers in the lab.This complaint can be cancelled as the inability to deploy the stent would have resulted from the stent strut protruding from the sheath".All malfuctions have been captured under (b)(4).This report is being submitted as a cancellation report.

• 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: 9671253
• Report Number: 3001845648-2020-00080
• Device Sequence Number: 354019
• Product Code: FGE
• UDI-Device Identifier: 10827002506234
• UDI-Public: (01)10827002506234(17)220222(10)C1588457
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 02/22/2022
• Device Model Number: G50623
• Device Catalogue Number: ZILBS-635-8-8
• Device Lot Number: C1588457
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 62