MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number	G48038
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	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Us clearance number: (b)(4).This file was created to deal with flexor kink / break.This report is being submitted as a cancellation report as lab evaluation received showed no evidence of flexor kink / break.
Event or Problem Description
This file was created to deal with flexor kink / break.This report is being submitted as a cancellation report as lab evaluation received showed no evidence of flexor kink / break.During a stent placement in the colon, the evolution delivery system ¿snapped¿ when pushing the trigger to move the stent forward and they had to replace it with another evolution (same size) to complete the procedure.No harm to the patient and successful procedure with the second evolution stent used.
Additional Manufacturer Narrative
Us clearance number: k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During a stent placement in the colon, the evolution delivery system ¿snapped¿ when pushing the trigger to move the stent forward and they had to replace it with another evolution (same size) to complete the procedure.No harm to the patient and successful procedure with the second evolution stent used.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9326584
• Report Number: 3001845648-2019-00601
• Device Sequence Number: 2616743
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)210208(10)C1584178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1584178
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1