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

Model Number	G48025
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event stent cannot be deployed.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
Device evaluation: the evo-22-27-6-d device of c2223540 lot number involved in this complaint was returned opened in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 07th of january 2026.On evaluation, the following was observed: visual inspection: stent partially deployed on returned, safety wire not returned, red marker before point of no return, damage on introducer observed below handle, directional button in deploy position, handle opened, outer sheath separated from shuttle, all other components intact.Functional inspection: handle actuating fine for deployment and recapture.Unable to deploy stent.The reported failure was observed.Manufacturing records review: prior to distribution, all evo-22-27-6-d devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-22-27-6-d device of lot number c2223540 did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: a review of the manufacturing records for the evo-22-27-6-d device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2223540.Instructions for use and/label review: it should be noted that as per ifu0053 which accompanies this device instructs the user to inspect the device prior to 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".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 could be attributed to the patients anatomy and the delivery path of the device in the patient.Although the user has stated that there was no resistance felt during the procedure, it is possible that the patients anatomy and the delivery path of the device may have caused a build-up of pressure within the device while advancing and resulted in the difficulty when attempting deployment.The intestines can have sharp bends with angles that can range from gentle curves to sharp bends.This natural tortuosity could have complicated the navigation and deployment of the device.During the device evaluation, the stent was noted to have been partially deployed.Deployment attempts could have increased forces within the device, leading to the separation of the outer sheath from the shuttle cap resulted in the inability to deploy the stent.Another possible root cause could be the premature removal of the safety wire.In the device evaluation, it was observed that the red marker was before the point of no return and that the safety wire was removed.Clarification on when the red safety wire was removed, was requested but this information has yet to be provided.Should this clarification be received at a later date, the file will be updated accordingly.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, stent cannot be deployed.Confirmed quantity, 01 device was confirmed used.According to the initial reporter, the patient did not require any additional procedures due to this occurrence nor experience any adverse effects due to this occurrence investigation findings conclude that a definitive root cause could not be determined.A possible root cause could be contributed to patients anatomy and the delivery path of the device in the patient causing a build-up of pressure and resulting in the issue reported.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 26-jan-2026.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM,STENT, METALLIC, EXPANDABLE, DUODENA
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23767057
• Report Number: 3001845648-2025-00626
• Device Sequence Number: 16100506
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)261010(10)C2223540
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K163468
• 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): 01/26/2026

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 Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C2223540
• 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: 10/20/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG