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

Catalog Number	EVO-10-11-6-B
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
On (b)(6) 2016 date of first implant procedure due to liver metastasis from ovarian cancer.2 stents placed in trans gastric evo-10-11-6-b lot c1154740.Stents were placed in each other.Patient received chemotherapy on (b)(6) 2016 to (b)(6) 2018.Stent partial migration (b)(6) 2016.13 days post procedure.Resulting in inability to perform intended function and replacement.Treatment endoscopic intervention placement of new stent.2 stents side by side (only one is from cook) one stent migrated leading to an angulation with the higher protesis.The site determined the event to possibly be related to the study device.Re-current biliary obstructions (b)(6) 2017.367 days post procedure.Due to tissue or tumor overgrowth.Obstruction noted to be within a study stent.Treatment endoscopic intervention placement of new stent.The site determined the event to not be related to the study device or procedure, related to progression of cancer.(b)(4) re-current biliary obstructions (b)(6) 2017.521 days post procedure.Due to tissue or tumor overgrowth.Obstruction noted to be within a study stent.Treatment endoscopic intervention placement of new stent.The site determined the event to not be related to the study device or procedure, related to progression of cancer.(b)(4) re-current biliary obstructions (b)(6) 2018.925 days post procedure.Due to tissue or tumor overgrowth.Obstruction noted to be within a study stent.Treatment endoscopic intervention placement of new stent.The site determined the event to not be related to the study device or procedure, related to progression of cancer.(b)(4).All three reinterventions for recurrent biliary obstruction were noted to be successful.On (b)(6) 2018, the patient died of biliary sepsis.This file will capture the off-label use of trans gastric placement which led to the partial migration 13 days post procedure.
Additional Manufacturer Narrative
Device evaluation the evo-10-11-6-b device of lot number c1154740 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4) and was created in response to the pmcf study.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.Instructions for use and/label review: it should be noted that the instructions for use (ifu0056) states the following: ¿this device is used in palliation of malignant neoplasms in the biliary tree.¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause can be attributed to the abnormal use of the device.From the information provided it is known that the location of the stent placement was trans gastric.As previously noted, the ifu states ¿¿the device is used in palliation of malignant neoplasms in the biliary tree.¿ it was reported that the stent migrated 13 days post procedure.The stent migration was likely caused by trans gastric placement.The user has not complied with the requirements of the ifu with respect to the intended use, indications for use or contraindications of the device.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of (b)(4) used device.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the initial reporter, the stent was implanted on the (b)(6) 2016.Partial stent migration was reported 13 days post procedure resulting in inability to perform its intended function.The patient required the placement of a new stent as a result of this occurrence.It was reported that the patient recovered/stabilised following this.A definitive root cause of abnormal use of the device was determined.Complaints of this nature will continue to be monitored for similar events.Confirmed quantity of (b)(4) used device.Patient death was reported on the (b)(6) 2018, the cause of death was due to biliary sepsis.As per medical advisor input the cause of death was due to biliary sepsis secondary to progression of cancer.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 16-jan-2025.

• 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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 20901929
• Report Number: 3001845648-2024-00807
• Device Sequence Number: 5052885
• Product Code: FGE
• UDI-Device Identifier: 10827002231280
• UDI-Public: (01)10827002231280(17)170924(10)C1154740
• Combination Product (Y/N): N
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 09/24/2017
• Device Catalogue Number: EVO-10-11-6-B
• Device Lot Number: C1154740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2016
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 68 KG