MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48028

Device Problem Delivery System Failure (2905)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).The customer reported the following complaint issue: ¿the user advanced device along wire guide under colonoscopy to desired position successfully, then the user pulled the trigger with hand, the red vernier kept moving backwards but under the x-ray, the stent didn't release at all.Then the user withdraw the device and try again in vitro, the stent still could not released.At last, the user finished the procedure by change another new one.¿ the following additional information was provided: ¿was there any noise in the handle or problem with the trigger while deploying? no.Was the stent partially deployed? completely not.Was there any damage noted on the device during or prior to use? no¿.An image was provided, the image shows the back half of the device with the red shuttle past the point of no return and the lockwire partially pulled.One x evo-25-30-8-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the lockwire had partially pulled from the device on return and there was no stent exposure from the sheath.The red shuttle deployment marker was seen to be at the back of the handle.Actuation for deployment or retraction was not possible.The handle of the device was dismantled during lab evaluation to show that the flexor had broken at the shuttle cap.The stent was manually deployed and noted to be fine.Customer complaint confirmed as failure was verified in laboratory.The customer complaint was confirmed as the flexor was seen to be broken at the shuttle cap during lab evaluation.As usage condition cannot be replicated within the laboratory setting, a definitive root cause cannot be conclusively determined.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution all evo-25-30-8-c devices are subjected 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 c1184272 revealed (b)(4) devices were scrapped under nc ¿(b)(4)¿ for ¿bunching of flexor¿.As per manufacturing process, the flexor sub-assemblies would have been scrapped.The non conformances would therefore not be applicable for the failure mode involved in this complaint.There were no other discrepancies in the manufacturing records that could have contributed to this complaint issue.It may be noted that a project was assigned at this time to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.There is no evidence to suggest that this issue affects the entire lot #; upon review of complaints this failure mode has not occurred previously with this lot #.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".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for 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

Initial mdr is being submitted based on the device malfunction precedence of 'flexor kinked/stretched/broke/compressed'.The user advanced device along wire guide under colonoscopy to desired position successfully, then the user pulled the trigger with hand, the red vernier kept moving backwards but under the x-ray, the stent didn't release at all.Then the user withdraw the device and try again in vitro, the stent still could not released.At last, the user finished the procedure by change another new one.

• 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: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6998568
• MDR Text Key: 92050194
• Report Number: 3001845648-2017-00511
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)171217(10)C1184272
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/05/2017

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 Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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: 82 YR
• Patient Weight: 55