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

Model Number	G48038
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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
User detected the stent cannot be deployed anymore after 50% of stent was already released.And the retraction wire is already pulled out.User pulled the delivery system and stent together from patient.User changed to boston scientific stent to complete the procedure."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.".
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 30 jun 2025.
Additional Manufacturer Narrative
Device evaluation: the evo-25-30-10-c device of c2115489 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 29th jan 2025 and re-evaluated on the 10th jun 2025.Visual inspection: stent returned partially deployed.Red shuttle past ponr.Safety wire not returned.0.035 inch size wire guide returned within the device.Inner canula slightly exposed from the handle.Functional inspection: handle actuating with slight resistance for deployment and recapture.Unable to deploy stent and unable to recapture stent.Unable to remove the wire guide.Handle opened and canula observed to be kinked severely.All cogs intact.Cannula cut proximally, wire guide removed with no issues.Cut the outer sheath distal to the handle.Shuttle along cannula as intended.Outer sheath manually removed.Manually deployed the stent, with no issue.Image provided shows inner canula slightly exposed from the handle.Manufacturing records review: prior to distribution, all evo-25-30-10-c devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-25-30-10-c device of lot number c2115489 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-25-30-10-c 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 c2115489.Instructions for use and/label review: it should be noted that as per instructions for use ifu0052 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use." there is evidence to suggest that the customer did not follow the instructions for use, as per additional information provided the product was not inspected for kinks or damage before use.Therefore, as per section 6.6.3 of (b)(4) rev007 these events have been documented in the pms log.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 contributed to the torturous path causing a build-up of pressure and resulting in the issue reported.As per additional information received there was resistance when this issue occur and handle separated during stent deployment at release of 50%.It may be noted that the product was not inspected for kinks or damage before use.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 of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a possible root cause could be attributed to to the torturous path causing a build-up of pressure and resulting in the issue reported.As per additional information received there was resistance when this issue occur and handle separated during stent deployment at release of 50%.It may be noted that the product was not inspected for kinks or damage before use.Complaint is confirmed based on visual and/or functional inspection.

• 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; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 21137553
• Report Number: 3001845648-2025-00010
• Device Sequence Number: 12658288
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)251120(10)C2115489
• 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): 06/30/2025

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: 11/20/2025
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C2115489
• 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: 11/12/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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: 70 YR
• Patient Sex: Male