MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

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 06/29/2017

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 applicable to this event.Equivalent rpns verified for regulatory clearance checks.Pma/510(k) # k121430.(b)(4).The following additional information was requested: ¿was there resistance felt inserting the device into the scope or patient and was the path torturous?¿ to which the rep responded 'no'.The 1 x evo-fc-10-11-6-b was returned to (b)(4) for evaluation.Upon evaluation of the returned device it was noted that the lockwire was in place on return.The red shuttle deployment marker was at the 5th dimple towards the front of the handle.There was no stent exposure from the sheath on return.Deployment or retraction was not possible.There was no damage noted to the zip port during lab evaluation.The handle was dismantled during lab evaluation to show that the flexor had broken.There was a kink in the flexor which possibly could have caused high forces leading to the flexor breaking.Heavy resistance was noted when attempting to deploy the stent manually.The kink in the flexor was straightened which relieved the pressure slightly.The customer complaint was confirmed as the flexor was broken.As usage conditions cannot be replicated in the laboratory setting, a definitive root cause for this complaint could not be conclusively determined.Potential root cause for this issue are as follows:" - damage during transportation - damage during or prior to packaging - handling damage by user - excessive forces applied to system - incompatible accessory devices or scope selected." 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 (b)(4).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 did not open correctly and could not be released, there was a cracking sound in the trigger system during attempt of stent release.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
• 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: 6759754
• MDR Text Key: 82832171
• Report Number: 3001845648-2017-00310
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002231341
• UDI-Public: (01)10827002231341(17)190328(10)C1341065
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2017

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: 08/02/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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