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 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k163468 (b)(4).The following additional information was provided: ¿the doctor advised that the stent did partially deploy, however the stent didn¿t remain in the patient.When the delivery stent was removed from the patient, it still had the stent in it.¿ 1 x evo-25-30-8-c was returned to cook (b)(4) for evaluation.Upon evaluation of the returned device it was noted that there was no stent exposure from the sheath and the lockwire was in place.There was a kink in the flexor at the handle.The red shuttle deployment marker was towards the front of the handle.Deployment was not possible during lab evaluation.The handle was dismantled during the lab to show that the flexor was broken at the shuttle cap.The stent was manually deployed and noted to be fine.The customer complaint was confirmed as the flexor was broken at the shuttle cap.A possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.Prior to distribution all evo-25-30-8-c devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cook (b)(4).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

Olympus colonoscope was advanced within the colon.A.035 guide wire was advanced through the colonic stricture.The evolution colonic stent was advanced over the pre-positioned guide wire.During deployment of the stent, a snap was heard (assuming within the delivery system) and the evolution colonic stent failed to deploy from the delivery system.

Manufacturer Narrative

Pma/510(k) # k163468.(b)(4).Exemption number: e2016031.(b)(4).Additional information: it may be noted that a project (b)(4) has been assigned to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.

Event Description

Olympus colonoscope was advanced within the colon.A.035 guide wire was advanced through the colonic stricture.The evolution colonic stent was advanced over the pre-positioned guide wire.During deployment of the stent, a snap was heard (assuming within the delivery system) and the evolution colonic stent failed to deploy from the delivery system submitting follow up report to add reference to project assigned to product development to further investigate stent deployment issues of this nature in an effort to eliminate future occurrences.26-apr-2018.

• 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: 6841033
• MDR Text Key: 85944170
• Report Number: 3001845648-2017-00378
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190207(10)C1323557
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

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 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: 09/04/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/04/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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