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 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Problem statement: operator cannot pull the trigger to release the stent.The trigger cannot be pulled.Device evaluation: the evo-25-30-8-c device of lot number c1359935 was returned to cook (b)(4) and evaluated on the 17 jan 2018.Lab evaluation: upon evaluation of the returned device, the lockwire was still in place.Upon actuation, deployment or retraction was not possible.The red shuttle deployment marker was at the back half of the handle.There was damage noted to the flexor near the handle of the device, this may have been due to patient anatomy or handling of the device.There was no stent exposure on return.The device was dismantled during the lab, and the flexor was noted to be broken at the shuttle cap.The stent was manually deployment during the lab and there were no issues noted with the stent.Customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken at the shuttle cap.Root cause: a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.Document review: 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.Ifu review: 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.Summary: customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken at the shuttle cap.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" operator cannot pull the trigger to release the stent.The trigger cannot be pulled.

• 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: 7269882
• MDR Text Key: 100278093
• Report Number: 3001845648-2018-00064
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190524(10)C1359935
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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
• Patient Age: 36 YR