MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G23129
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The doctor reports that the prosthesis released correctly.At the time of removing the device and revising, it was noted that the prosthesis was in a different position from the initial.An endoscopic review observed a piece of the internal catheter of the release device and the doctor was able to removed it.Afterwards the doctor decided to place another metallic prothesis without any issues.
Event or Problem Description
It was further reported the stent remained inside the bile duct and they did not remove it and chose to place another evolution stent.

• Brand Name: EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10373012
• Report Number: 3005580113-2020-00389
• Device Sequence Number: 2567254
• Product Code: DTK
• UDI-Device Identifier: 10827002231297
• UDI-Public: (01)10827002231297(17)220124(10)C1702268
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020
• Report Date (Section F): 10/07/2020

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: 01/24/2022
• Device Model Number: G23129
• Device Catalogue Number: EVO-10-11-8-B
• Device Lot Number: C1702268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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