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 Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted with the investigation conclusions.(b)(4).

Event Description

This report forms part of a retrospective review of open complaints for a new malfunction precedence for this device family.Attempting to deploy stent and it would not deploy.Doctor pushed recapture button thinking it would help and heard a pop.Stent was then removed from patient.The doctor opened and used two more stents (g48028-evo-25-30-8-c) to complete the procedure successfully.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).The following additional information was also provided: ¿could you clarify if the stent was deployed in the patient and then retrieved? or if the stent was partially deployed when removed from the patient's body? the stent did not deploy.¿ 1 x evo-25-30-8-c was returned to cirl for evaluation.On evaluation of the returned device, it was noted that the stent was partially exposed from sheath on return.However, as the following information was provided: ¿could you clarify if the stent was deployed in the patient and then retrieved? or if the stent was partially deployed when removed from the patient's body? the stent did not deploy¿, it is assumed that the stent became exposed when device was removed from the patient due to pressure release.The red shuttle deployment marker was towards the back half of the handle on return.The lockwire was still in place.It was not possible to deploy or retract the stent as actuation of the device was not possible pulling the trigger.The handle was dismantled during lab evaluation to show that the flexor had broken at the shuttle cap.The stent was manually deployed and was noted to be fine.The customer complaint was confirmed as the flexor was broken at the shuttle cap.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 there were no other discrepancies in the manufacturing records that could have contributed to this complaint issue.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".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 follow up mdr is being submitted to include the investigation conclusions.Attempting to deploy stent and it would not deploy.Doctor pushed recapture button thinking it would help and heard a pop.Stent was then removed from patient.The doctor opened and used two more stents (g48028-evo-25-30-8-c) to complete the procedure successfully.

• 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: 6720841
• MDR Text Key: 80417096
• Report Number: 3001845648-2017-00276
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)180818(10)C1263177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113510
• 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,Followup
• Report Date: 07/18/2017

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: 05/12/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1