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 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).As per source doc "phone call received from rep on the (b)(6) 2017 at 11h00.While the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter"."as per complaint form": while the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter.It has been stated that the evo-25-30-8-c device of lot number c1249418 involved in this complaint is being returned to cook ireland for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.As the device was not returned at the time of the investigation, the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.Prior to distribution all evo-25-30-8-c 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 cirl.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number.As per 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 evidence to suggest that the user did not follow the instructions for use.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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: ¿flexor kinked/stretched/broke/compressed".As per source doc "phone call received from rep on the (b)(6) 2017 at 11h00.While the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter"."as per complaint form": while the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter.

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Exemption number: e2016031.(b)(4).This follow up mdr is being submitted to cancel the initial mdr report.A conservative approach was taken in initially assessing this complaint.After the lab evaluation no functional issues were noted.The flexor was not damaged and the device functioned as intended.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This cancellation mdr is being submitted to cancel the initial report as the lab evaluation found the device had no functional issues.Initial mdr submitted based on the device malfunction precedence: ¿flexor kinked/stretched/broke/compressed".As per source doc "phone call received from rep on the 27-dec-2017 at 11h00.While the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter"."as per complaint form": while the stent was launched, the stent remained inside the catheter, even though the staff pressed the launching button.They retrieved the system form the endoscope.They tried it again but not on patient, and observed that the stent remained inside the catheter.

• 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
• MDR Report Key: 7215080
• MDR Text Key: 98307671
• Report Number: 3001845648-2018-00035
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)180707(10)C1249418
• 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
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1