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

Model Number G48038

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

510(k) number: k163468.(b)(4).The evo-25-30-10-c device of lot number c1526544 was unavailable for evaluation.With the information provided, document based investigation was conducted.This complaint file is dealing with the stent migration.An additional file was opened to deal with the second issue - the yellow marker not being visible.As per customer testimony stent placement was complete prior to removal.Documents review including ifu review: prior to distribution all evo-25-30-10-c devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-25-30-10-c device of lot number c1526544 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1526544; upon review of complaints this failure mode has not occurred previously with this lot #c1526544.The instructions for use ifu0052-10 which accompanies potential complications: "additional complications include, but are not limited to: stent migration; stent occlusion, ulcerations".There is no evidence to suggest that the customer did not follow the instructions for use ifu0052-10.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient anatomy, as per instructions for use, (ifu0052-10), stent migration is listed as a complication following the placement of this device.Summary: complaint is confirmed based on customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: "yellow marker that you should be able to see endoscopically during placement was not moving in coordination with trigger deployment device.They'd never seen that occur before.Couldn't see movement between yellow marker and blue.After placement, stent migrated and then physician removed.Removed complaint device prior to placement and completed procedure with another device successfully".

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8292685
• MDR Text Key: 134592381
• Report Number: 3001845648-2019-00035
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)200803(10)C1526544
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2020
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1526544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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