MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

Model Number	G23127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sepsis (2067)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name: fge catheter, biliary, diagnostic - biliary stent - metal.
Event or Problem Description
According to the initial reporter: two to three days after the patient underwent an ercp procedure in which the evolution biliary controlled-release stent - uncovered, g23127, was used, the patient had biliary sepsis.
Event or Problem Description
It was further reported that the issue occurred when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal 2-3 days post procedure.The patient was hospitalized due to obstructive jaundice and underwent endoscopic retrograde cholangio-pancreatography (ercp) as an in patient; he remained hospitalized until his death.Became hypotensive evening after stent placement, transferred to icu, ct obtained, but was unstable to undergo emergency ercp.By the time he was stabilized, family opted for hospice.Furthermore, patient was not stable enough to undergo emergency ecrp on initial transfer to icu and was placed on hospice the following morning.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10010090
• Report Number: 3005580113-2020-00358
• Device Sequence Number: 16696453
• Product Code: FGE
• UDI-Device Identifier: 10827002231273
• UDI-Public: (01)10827002231273(17)210123(10)C1578915
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020
• Report Date (Section F): 05/12/2020

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: 01/23/2021
• Device Model Number: G23127
• Device Catalogue Number: EVO-10-11-4-B
• Device Lot Number: C1578915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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
• Date Report Sent to FDA: 05/12/2020