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	Activation, Positioning or Separation Problem (2906)
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
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.
Additional Manufacturer Narrative
Pma/510(k) #: k163018.Device evaluation: the zilbs-635-8-8 device of lot number: c1588457 involved in this complaint was returned for evaluation, with 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 the 13feb2020.There was fish mouth damage at the tip.There was damage along the flexor at the coil section.The stent was protruding through the sheath near the tip.All failure modes are linked to the excessive force that was used.Document review: prior to distribution zilbs-635-8-8 devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1588457) 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: c1588457.There is no evidence to suggest the user did not follow the ifu(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 excessive force being applied to the handle.The damage along the coil section may have happened as the stent was pushed out through the sheath.The fish mouth damage may also be a result of the excessive force.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.

• 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: 9675249
• Report Number: 3001845648-2020-00079
• Device Sequence Number: 19428867
• 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): 07/13/2020

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?: Yes
• 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: 02/06/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 62