MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number	EVO-22-27-12-D
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
User advanced the stent delivery system into patient but found out the stent cannot be deployed.User pulled the device out by force and the stent broken inside the patient.Updated on 24jun2024 tp: broken stent was removed by surgery with another procedure arrange (actual date is unknown), the surgery procedure was conducted in another department in user facility.
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
Supplemental report is being submitted due to the completion of the investigation on 03-jan-2025.
Additional Manufacturer Narrative
Pma/510(k)#: k163468 device evaluation the evo-22-27-12-d device of lot number c2123633 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 03 july 2024.On evaluation of the device, the following was observed: visual inspection: ¿ red safety tab not returned ¿ directional button in recapture position ¿ red marker on 26th dimple (past ponr) ¿ safety wire partially removed on return ¿ outer sheath kink observed directly below handle ¿ outer sheath fully withdrawn on return ¿ no stent returned functional inspection: ¿ handle actuating fine for deployment and recapture ¿ safety wire removed with no issue photographic evidence provided by the customer showed the product label of the evolution device.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 (ifu0053) 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.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined.A possible root cause can be attributed to difficult patient anatomy and/or device handling.It is possible that the introducer kinked during device preparation or if the handle wasn't supported during the procedure, the kink would hinder deployment.During the lab evaluation it was observed that the outer sheath of the device was kinked below the handle.It is also possible that during deployment, tortuous patient anatomy and/or a tight stricture may have caused compression or exerted pressure on the catheter which may have resulted in the deployment difficulties reported.As a result of the deployment failure, the user removed the delivery system by force resulting in the partially deployed stent breaking and a portion of the stent remaining inside the patient.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Confirmed quantity of 01 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 broken stent was removed during another procedure.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: 19631095
• Report Number: 3001845648-2024-00315
• Device Sequence Number: 12542370
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)251212(10)C2123633
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2025
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C2123633
• 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: 05/30/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male