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

Model Number G23127

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Device name: fge catheter, biliary, diagnostic - biliary stent - metal.

Event 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 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
• MDR Text Key: 191426240
• Report Number: 3005580113-2020-00358
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002231273
• UDI-Public: (01)10827002231273(17)210123(10)C1578915
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/12/2020
• Distributor Facility Aware Date: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention