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

Model Number G48038

Device Problem Delivery System Failure (2905)

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

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).(b)(6).(b)(4).The customer reported the following complaint issue: ¿the user tried to deploy the stent during pre-test.The red marker on top of introducer worked normally but the tip of stent could not deploy.They pulled part of safety wire out but tip of stent still could not deploy.Replace new device to finish the procedure.¿ an image was provided, the image shows the red shuttle deployment marker in the back half of the handle and no part of the stent deployed from the sheath.1 x evo-25-30-10-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the lockwire had been pulled but hadn't been completely removed from the device.There was no stent exposure from the sheath.The red shuttle deployment marker was in the back half 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 during lab 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 excessive force applied.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution all evo-25-30-10-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 did not show any discrepancies in the manufacturing records that could have contributed to this complaint issue.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, this occurred prior to patient contact; there was no impact to the patient.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 tried to deploy the stent during pre-test.The red marker on top of introducer worked normally but the tip of stent could not deploy.They pulled part of safety wire out but tip of stent still could not deploy.Replace new device to finish the procedure.

• 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: 6997356
• MDR Text Key: 92059488
• Report Number: 3001845648-2017-00510
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)190316(10)C1336849
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48038
• 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: 11/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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