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

Model Number G48038

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/04/2019

Event Type  malfunction  

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 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.

Manufacturer Narrative

Us clearance number: k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event 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
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick
• MDR Report Key: 9326584
• MDR Text Key: 170773552
• Report Number: 3001845648-2019-00601
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)210208(10)C1584178
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2019
• 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