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 Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).The customer reported the following complaint issue: ¿the dr.Went down with the stent and upon deployment the device broke at the junction between the handle and the catheter.Removed the device and used another one to complete the case with no harm to the patient.¿ the 1 x evo-25-30-10-c was returned to (b)(4) for evaluation.On evaluation of the returned device, it was noted that the lockwire was in place on return and 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 with slight resistance 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 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-25-30-10-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 (b)(4).A review of the manufacturing records for this evolution device of lot revealed 09 devices were scrapped under a non conformance form for ¿bunching of flexor¿.As the devices were 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.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.' as reported to customer relations: "the dr.Went down with the stent and upon deployment the device broke at the junction between the handle and the catheter.Removed the device and used another one to complete the case with no harm to the patient.".

• 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: 6971002
• MDR Text Key: 90851781
• Report Number: 3001845648-2017-00482
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)180202(10)C1198077
• Combination Product (y/n): N
• PMA/PMN Number: K113510
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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