MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-10-11-6-B

Device Problem Delivery System Failure (2905)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us therefore mdr reporting criteria is applicable to this event.Equivalent rpns verified for regulatory clearance checks.(b)(4).The following additional information was provided: ¿the stent didn't deploy, because the mechanisms inside didn't work.¿ the 1 x evo-fc-10-11-6-b was returned to cirl for evaluation.Upon evaluation of the returned device it was noted that there was no stent exposure from sheath on return.Heavy resistance was noted on deployment and retraction.A kink was evident in the proximal flexor.This was straightened which significantly reduced the resistance felt on deployment and retraction.The stent was then fully deployed and noted to be fine.The customer complaint was confirmed as the flexor was kinked.As usage conditions cannot be replicated in the laboratory setting, a definitive root cause for this complaint could not be conclusively determined.Possible root causes for the issue may have been: " - damage during transportation - damage during or prior to packaging - handling damage by user - excessive forces applied to system".Prior to distribution all evo-fc-10-11-6-b 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.As per the instructions for use notes section the user is instructed of the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any 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

This initial report is being submitted due to the malfunction precedence: flexor kinked/stretched/broke/compressed the stent was correct on place but it was not possible to deploy it; the mechanism don't work inside the duct.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6743243
• MDR Text Key: 81511394
• Report Number: 3001845648-2017-00305
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)190303(10)C1332818
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

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-FC-10-11-6-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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