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 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The evo-25-30-8-c device of lot number c1354538 was not available for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing condition: reoccurrence ureter transitional cell cancer.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.The following additional information was received from the cook representative: was the patient anatomy torturous? yes, the curves where with sharp angles.Was resistance encountered when advancing the stent and introducer through the obstructed area? yes, it was a very stiff ureter transitional cell cancer.Was the directional button fully engaged during deployment? yes.Engineering input was requested in a weekly meeting to review the imaging and information provided and determine a potential root cause of this event.No additional comments were made in relation to the image received.The most likely root cause of this event was determined to be the torturous anatomy, causing a buildup of pressure and resulting in the flexor breaking.This would account for the physicians inability to deploy the stent as reported.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.Upon review of complaints, this failure mode has not occurred previously with the lot number c1354538.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1354538.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: 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".The stenosis was seen by the colonoscope, than guide wire was delivered through cannula and colonic stent was delivered over the guide wire.While deploying the stent the trigger suddenly made a crash voice and the stent could not be deployed anymore.The stent was removed and exchanged by another same stent.Reporting based on precedence of flexor kinked/stretched/broke/compressed" issue for this device family.

• 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: 7341381
• MDR Text Key: 103146043
• Report Number: 3001845648-2018-00123
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190509(10)C1354538
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2018
• Date Device Manufactured: 05/09/2017
• 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