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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Obstruction/Occlusion (2422)
Date of Event	01/01/2020
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
(b)(6) 2019 date of first implant procedure in cbd.No adverse events related to the procedure.Not documented if fluoroscopy was used.Chemotherapy received (b)(6) 2017 to (b)(6) 2018.Re-current biliary obstructions (b)(6) 2020.At 11 days post-procedure.Due to food impaction.Patient presented with nausea.Treatment endoscopic intervention new stent inside study stent and antibiotics.The site determined the event to not be related to the study device or procedure.Patient death (b)(6) 2021.Patient outcome: the reintervention was noted to be successful.On (b)(6) 2021, the patient died.The cause of death was unknown.Dash sphincterotome used.
Event or Problem Description
A supplemental report is being submitted due to the completion of the investigation on 02-dec-2024.
Additional Manufacturer Narrative
Device evaluation: the evo-10-11-6-b device of lot number c1659873 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.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) lists ¿stent occlusion¿ as a potential adverse event.There is no 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 could not be determined.A possible root cause can be attributed to a known potential adverse event.From the study, the obstruction was due to food impaction.As previously noted, ¿stent occlusion¿ is listed as a potential adverse event in the ifu.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01 x 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) 2019.The patient presented with nausea 11 days post procedure due to recurrent biliary obstruction and required the placement of a new stent and antibiotics as a result of this occurrence.It was reported that the patient recovered/stabilised following this.Patient death was reported on the (b)(6) 2021, the cause of death was unknown, from medical advisor input the death was due to tissue or tumour ingrowth.

• 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: 20785603
• Report Number: 3001845648-2024-00690
• Device Sequence Number: 5004072
• Product Code: FGE
• UDI-Device Identifier: 10827002231280
• UDI-Public: (01)10827002231280(17)211016(10)C1659873
• 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): 12/02/2024

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 Catalogue Number: EVO-10-11-6-B
• Device Lot Number: C1659873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/01/2020
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female
• Patient Weight: 54 KG