MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number EVO-25-30-8-C

Device Problems Break (1069); Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon evaluation of the returned device, it was noted that no lockwire was returned with the device.The stent, tip and polyimide were not returned.The red shuttle deployment marker was towards the middle of the handle on return.There was a kink in the flexor and the coiled section which did not impact deployment as deployment and retraction were possible.Scope used ¿gif2f240 evis gastroscope olympus dual channel¿, channel size of this scope was checked by cook ireland engineer: ¿i cannot find any gif-2f240 olympus gastroscope but i did find other dual channel gif-2th180 which had a 2.8mm and 3.7mm channel.¿ flexor diameter is approximately 3.4mm which would indicate user error as the incorrect channel size could have led to the peek to polyimide joint failure.The customer complaint was confirmed on customer testimony, however, it may be noted that user error is suspected as the channel size of the scope is thought to have been smaller than the diameter of the flexor.The smaller channel size of the scope was confirmed to be 2.8mm.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.There is no evidence to suggest that this issue affects the entire lot # c1246750; upon review of complaints this failure mode has not occurred previously with this lot # c1246750.As per instructions for use, precautions section: ¿refer to product package label for the minimum channel size required for this device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient was terminal and it was felt that it was unnecessary to put them through another procedure.The patient has since passed away.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

We have a colonic stent that malfunctioned when we deployed it in a patient.The stent fully deployed in the patient's colon; however, an extra piece of wire, the part with the white tip that the stent is deployed from also came off and got stuck inside the patient's colon.The metal that was then exposed on the end of the stent also caused damage to our endoscope as we pulled the wire of the scope "as per complaint form": the stent was initially placed down the small channel of the scope which was to small then it was transferred and put down the larger channel.The stent was deployed and when this was taking place the toggle and the internal wire dislodged from the end of the stent and was left inside the patient due to the stent being deployed in the incorrect place a second stent was deployed without incident.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6581485
• MDR Text Key: 75640577
• Report Number: 3001845648-2017-00185
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)180630(10)C1246750
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K113510
• 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: 04/24/2017

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?: No
• Device Operator: Health Professional
• 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: 05/22/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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
• Patient Outcome(s): Required Intervention