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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # = k163018.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations "during deployment of the stent, they attempted to reposition the stent and the stent ended up shredding into multiple pieces that were left behind in the biliary duct.After that, they had to retrieve the pieces.They used biopsy forceps, a snare and an extraction balloon.They were able to get all of the pieces out.They ended up placing a boston scientific wall flex uncovered biliary stent to successfully complete the procedure".
Additional Manufacturer Narrative
Pma/510(k) # = k163018.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: (b)(4).Device evaluation: the zilbs-635-8-10 device of lot number c1484442 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.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 15 november 2018.The stent was returned in three pieces and the wire guide was stuck inside the delivery system.Document review: prior to distribution all zilbs-635-8-10 devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures.A review of the relevant manufacturing records for zilbs-635-8-10 of lot number c1484442 did not reveal any discrepancies that could have contributed to this complaint.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 evidence or no evidence to suggest that there are any manufacturing issues associated with lot number c1484442.Ifu review it may be no:ted that the instructions for use states the following: ¿these metal biliary stents are not intended to be repositioned or removed after deployment in the bile duct.In case of accidental deployment or improper placement (immediately following deployment), leave the stent in place.¿ root cause review: a definitive root cause of user re-positions the stent after deployment had commenced was identified from the information provided and during the laboratory evaluation.It was confirmed that the physician repositioned the stent after deployment had commenced causing the stent to fracture into multiple pieces.Summary: complaint is confirmed as the failure was verified in the laboratory.The stent was returned in multiple pieces and was damaged.According to the initial reporter, the pieces of shredded stent had to be retrieved from the patient using a biopsy forceps, a snare and an extraction balloon.All of the pieces were retrieved and a boston scientific wall flex uncovered biliary stent was used to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations "during deployment of the stent, they attempted to reposition the stent and the stent ended up shredding into multiple pieces that were left behind in the biliary duct.After that, they had to retrieve the pieces.They used biopsy forceps, a snare and an extraction balloon.They were able to get all of the pieces out.They ended up placing a boston scientific wall flex uncovered biliary stent to successfully complete the procedure.".

• 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: 8068453
• Report Number: 3001845648-2018-00529
• Device Sequence Number: 14023284
• Product Code: FGE
• UDI-Device Identifier: 10827002238135
• UDI-Public: (01)10827002238135(17)210515(10)C1484442
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: G23813
• Device Catalogue Number: ZILBS-635-8-10
• Device Lot Number: C1484442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention