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
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k163468 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
On (b)(6) 2024, when cgh start to deploy the stent, the stent was deployed without pulling back the safety wire.
Event or Problem Description
Clarification received on (b)(6)2024.The stent was deployed prematurely before safety wire being pulled and it was removed together with the delivery system.A supplemental report is being submitted due to completion of the investigation on 19 sep 2024.
Additional Manufacturer Narrative
Pma/510(k) # k163468.Device evaluation the evo-25-30-8-c device of lot number c2117663 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: it should be noted that the instructions for use (ifu0052) states the following: ¿confirm desired stent position fluoroscopically and deploy stent by removing red safety guard from the handle.¿ ¿continue deploying stent by squeezing the trigger.¿ ¿ when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port.¿ ¿continue deploying stent by squeezing trigger¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.From additional information received from the customer, the intended target location was reached, the stent partially deployed before removal of the safety wire, the stent was then removed together with the delivery system.As the stent is intended to partially deploy prior to removing the safety wire, it is possible that the customer means that the stent partially deployed prior to pulling the trigger.It is possible that during advancement difficult anatomy caused compression of the outer sheath which led to the partial premature deployment of the stent.However, as the device was not returned for evaluation, the cause of this complaint could not be conclusively determined.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of (b)(4) x used device.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another colonic sent was used to complete the procedure.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19200588
• Report Number: 3001845648-2024-00194
• Device Sequence Number: 7927847
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)251127(10)C2117663
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2025
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C2117663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown