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 Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

On evaluation of the returned device, it was noted that upon actuating the handle there was no movement of the device.The safety wire was not returned with the device.The stent was returned partially deployed.The handle assembly was dismantled during the evaluation by the cirl research & development engineer and it was noted that the flexor had snapped at the shuttle cap.The stent was deployed by hand when force was applied during the evaluation.It was noted that 2 crowns on the stent were displaced on the distal end of the stent and 2 crowns were displaced on the proximal end of the stent.The customer complaint was confirmed as the stent could not be deployed as the flexor was broken within the handle.A possible cause of this damage occurring may have been that it was a tortuous anatomy.Another possible cause could be that there was massive pressure and force may have been applied when attempting to deploy the stent.However, as actual use conditions could not be replicated in the laboratory we cannot conclusively determine the cause of this complaint.Prior to distribution, all evo-25-30-10-c devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for this evolution device of lot c1097209 did not reveal any discrepancies that could have contributed to this complaint issue.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

According to normal procedure to release the evo stent, the physician found the stent cannot be fully deployed after the stent was deployed about 1cm.Part of the stent was exposed from the delivery system when the device was removed from the patient.Procedure was finished by changing to a new device.Incident meets the reporting criteria of an fda mdr report based on the reporting malfunction precedence for this device family for 'deployment issue resulting in exposed stent removed from patient with the delivery system'.

• 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: 5263695
• MDR Text Key: 32602851
• Report Number: 3001845648-2015-00267
• 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: Physician
• Type of Report: Initial
• Report Date: 11/06/2015

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
• 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: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 72 YR
• Patient Weight: 65