MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23128
Medical Device Problem Codes	Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).On (b)(6) 2015, 16 days post procedure -non permeability of prothesis managed by endoscopic treatment.Placement of a 3rd plastic biliary prosthesis allowing to make the junction between 2 prostheses between 2 prostheses whose angulation did not make them permeable.Patient outcome: endoscopic treatment status: resolved, treatment: endoscopic; placement of a 3rd plastic biliary prosthesis between 2 stents, to make them permeable, death: yes.Date of death - (b)(6) 2016 - unknown cause of death.
Additional Manufacturer Narrative
Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: the 1 x evo-10-11-6-b device of lot number c1127358 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to a pmcf study ¿mdr202¿ to capture ¿non permeability of prosthesis¿.'non-permeability' was deemed related to stent obstruction/occlusion as per medical advisor's input.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: as per the ifu (ifu0056), stent occlusion and death are known potential adverse events associated with ercp: ¿additional adverse events that can occur in conjunction with biliary stent placement include, but are not limited to: allergic reaction to nickel, bile duct ulceration, death (other than due to normal disease progression), fever, inflammation, ingrowth due to tumour or excessive hyperplastic tissue, nausea, obstruction of the pancreatic duct, pain/discomfort, perforation, recurrent obstructive jaundice, stent migration, stent misplacement, stent occlusion, trauma to the biliary tract or duodenum, tumour overgrowth, vomiting¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to a procedural adverse event.As per the ifu (ifu0056), stent occlusion and death (other than due to normal disease progression), is a known adverse event associated with ercp.According to the study, the patients cause of death was unknown however, as per the relationship assessment in the casebook (page 28 & 29), the occlusion was unrelated to the stent, nor did the occlusion lead to the patients death.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: as per the pmcf study casebook, there was one case of ¿non permeability of prosthesis¿ evo-10-11-6-b recorded 16 days post-stent placement requiring endoscopic placement of a 3rd plastic biliary stent.Confirmed quantity of 1 used device.The investigation and root cause concluded that the occlusion was possibly caused by a procedural adverse event as it is indicated in the ifu as being a known potential adverse event associated with ercp.The cause of death of the patient was ruled as unknown with the stent being deemed unrelated to both the occlusion and death.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplementary report is being submitted due to the completion of the investigation on 12-jul-2023.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 16991781
• Report Number: 3001845648-2023-00393
• Device Sequence Number: 7039800
• Product Code: FGE
• UDI-Device Identifier: 10827002231280
• UDI-Public: (01)10827002231280(17)170706(10)C1127358
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2017
• Device Model Number: G23128
• Device Catalogue Number: EVO-10-11-6-B
• Device Lot Number: C1127358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2015
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 65 KG