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

Catalog Number EVO-25-30-10-C

Device Problems Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device involved in this event is currently being evaluated.A follow up report will be submitted with the final device investigation conclusions.The device involved in this event is currently being evaluated.A follow up report will be submitted with the final device investigation conclusions.

Event Description

The physician encountered difficulty during the deployment of the evolution colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.

Manufacturer Narrative

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the physician encountered difficulty during the deployment of the evolution® colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided '.Then the stent retracted from the patient together with the delivery system.' it was believed that the delivery system was removed from the patient with the stent partially deployed.This incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Initial complaint description submitted as follows: the physician encountered difficulty during the deployment of the evolution® colonic controlled-release stent.The stent was retracted from the patient together with the delivery system.The procedure was successfully completed with another evolution stent the following day.No adverse effects to the patient were reported to have occurred due to this incident.From the complaint information provided '.Then the stent retracted from the patient together with the delivery system.' it was believed that the delivery system was removed from the patient with the stent partially deployed.This incident initially met reporting criteria of an fda mdr report based on the reporting precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system' regardless of patient outcome.The device evaluation confirmed that the delivery system was returned for evaluation with no part of the stent exposed.The stent was fully retracted in the sheath.Based on the device evaluation this incident no longer meets the reporting criteria of an fda mdr report.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional mfg narrative-notes section for this justification.

• 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 Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5165344
• MDR Text Key: 28823087
• Report Number: 3001845648-2015-00202
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-25-30-10-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/21/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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 Age: 53 YR
• Patient Weight: 77