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

Model Number G48026

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Mum stent, metalic expandable, duodenal.

Event 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
• MDR Text Key: 203352567
• Report Number: 3005580113-2020-00396
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)220417(10)C1726654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2020,08/17/2020

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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention