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

Model Number	G48026
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mum stent, metalic expandable, duodenal.
Event or Problem Description
According to the initial reporter: customer deployed stent completely, and they did pull the safety wire at the end of deploying it completely.The tech did say they only pulled the safety wire out ~4 inches, so possibly not completely.Realized that the stent wasn't fully expanding and it was still attached to the delivery system catheter.Couldn't get it dislodged from the delivery system.They pulled it back and it ended up in the stomach, where it dislodged, so they had to go back down to use an over tube to get it out of the patient.Stent observed shredded once out of the patient, but they don't know when that happened.Customer used another of the same device to complete procedure successfully, longer procedure but not prolonged hospitalization.Further information was provided: the stent was not fully deployed.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10412766
• Report Number: 3005580113-2020-00396
• Device Sequence Number: 14049754
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)220417(10)C1726654
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2020
• Report Date (Section F): 08/14/2020

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: 04/17/2022
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1726654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2020
• 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