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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon evaluation of the returned device, it was noted that no lockwire, stent, tip or polyimide were returned.The red shuttle deployment marker was towards the front of the handle on return.There was a kink in the flexor at the handle which did not impact deployment as deployment and retraction were possible.It was confirmed that the broken piece of device 'was not left inside the patient as the stent deployed but as they thought it hadn¿t they pulled the wire out after completing the procedure but did not keep it.' it was also confirmed that the 2 unused devices returned did not have any complaint associated with them: ¿it was more a precaution than anything.¿ the customer complaint was confirmed on customer testimony; however, as per information provided by the rep this issue was user error.The stent was not placed in the correct position.Product manager has been contact to request that training be provided.Prior to distribution all evo-25-30-10-c devices are subjected to a 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 evo-25-30-10-c of lot number c1158682 did not reveal any discrepancies that could have contributed to this issue.As per instructions for use, ¿stent should be placed endoscopically with fluoroscopic monitoring." also, ¿confirm desired stent position fluoroscopically and deploy stent by removing red safety guard from the handle.¿ ¿after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

When they went to deploy the stent the doctor says it didn't deploy but rep says there is no stent left inside when she checked so rep thinks its deployed in the patient the second procedure was require due to the first stent being placed low in the sigmoid not the colon and due to a neoplasm obstruction it did not alleviate the patients symptoms hence the need for a repeat however it was evident when a second procedure was started that this was going to be unsuccessful due to the position of the tumour.This patient had advanced cancer so they were discussing this with the surgical team but i don't believe she would be a candidate for a repeat stent placement.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6603926
• MDR Text Key: 76381303
• Report Number: 3001845648-2017-00200
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)171007(10)C1158682
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/01/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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 Outcome(s): Hospitalization