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

Catalog Number EVO-25-30-8-C

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The complaint details received indicated the evolution stent crumpled on itself when the user released the stent.The user indicated the evolution stent would not be returned due to the infection of the patient.The evolution stent was disposed of by the user.No adverse effects to the patient have been reported as occurring.Although requested no further complaint details have been received.

Manufacturer Narrative

Initial information received indicates a possibility of the evolution stent did not expand and the stent was removed from the patient.This event meets the reporting criteria of an fda mdr report based on the reporting procedure for this product family for both 'permanent stent removal' and 'stent not opening/expanding fully'.As the device was not available to be returned; the cause of this complaint could not be conclusively determined.The customer complaint could be confirmed based on customer testimony.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure integrity.A review of the relevant manufacturing records for (b)(4) device of lot c1039412 did not reveal any discrepancies that could have contributed to this issue.From the information provided the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for emerging trends.

• Brand Name: EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior regulatory
• MDR Report Key: 4407513
• MDR Text Key: 19992176
• Report Number: 3001845648-2015-00004
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2016
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1039412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• 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