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 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

The delivery system was returned for evaluation with the stent partially deployed and the lock wire removed.On evaluation of the returned device, deployment of the stent was possible but not retraction, as no lock wire was present.The handle assembly was dismantled during the evaluation by the (b)(4) and it was noted that the flexor had stretched within the handle.The stent was deployed by hand when force was applied during the evaluation.There was no damage to the stent.All other inner components were examined and were ok.The customer complaint was confirmed as retraction was not possible and the flexor was stretched 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 subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for this evolution device of lot c1045311 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

The evolution colonic stent was passed over a guide wire, through the biopsy channel of an olympus colonoscope cf-q165.As the surgeon was satisfied that the stent was in the right place, we started its deployment.When the marker was on the point of no return and the stylet was removed, on continuing to fire the stent, there was a click and handle did not function any more.The stent was then pulled out from the colonoscope and procedure was abandoned.

• 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: 5636984
• MDR Text Key: 44613598
• Report Number: 3001845648-2016-00121
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)161015(10)C1045311
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: K113510
• 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
• Report Date: 04/12/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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
• Patient Age: 80