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

Catalog Number	EVO-25-30-10-C
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
User detected the stent cannot be released.User cannot confirm if the issue was caused by the sheath or stent.User has many years experience using the device, and it may not related to user's technique.Patient outcome: "a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".
Additional Manufacturer Narrative
Pma/510(k) # k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k163468.Device evaluation the evo-25-30-10-c device of lot number c2057250 involved in this complaint was returned for evaluation, with its opened original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 14th february 2024.On evaluation of the device, the following was observed: visual inspection: ¿ red safety tab not returned.¿ directional button in 'deployment' position.¿ safety/lock wire in place upon return.¿ red shuttle at 09th dimple (before point of no return).¿ kink noted directly below the handle.¿ outer catheter break noted approximately 28cm from white tip.Functional inspection: ¿ handle actuating fine for deployment and recapture.¿ unable to deploy stent due to outer catheter break.Kink at handle and flexor break were both observed by the customer prior to returning the device to cook 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: ¿if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization¿.There is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review : an image was not returned for evaluation.Root cause analysis : a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to handling of the device during the procedure or during device prep.The kink at the handle may have occurred if the handle was not adequately supported during use.The kink at the handle would have increased deployment force, causing the outer catheter to stretch and separate, subsequently leading to the issues reported.The kink at the handle and outer catheter break were observed in the lab evaluation.03 attempts were made to gain more information about this event, if more information becomes available, the file can be re-opened and updated.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01 x used device.Summary of investigation: 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 similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 26-jul-2024.

• 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: 18607365
• Report Number: 3001845648-2024-00036
• Device Sequence Number: 9128051
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)250529(10)C2057250
• 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): 07/26/2024

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: 05/29/2025
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C2057250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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 Age: 71 YR
• Patient Sex: Male