MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number	G48033
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The stent got stuck in the catheter and did not open fully, hence could not complete the stenting.
Additional Manufacturer Narrative
Device evaluation: the evo-20-25-15-e of lot: c2013060 was involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution, all evo-20-25-15-e devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for evo-20-25-15-e of lot number: c2013060 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred with lot number: c2013060.Instructions for use and/label: as per the instructions for use, ifu0061, which accompanies this device instructs the user to inspect the device prior to use: "visually inspect product 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 the user did not follow the ifu or label.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.There may be many possible root causes for the issue encountered, some may include the following: a possible root cause could be attributed to the difficult target site which could lead to a stent getting caught up on the delivery system tip, user technique or the suture getting caught up on the bi-lumen causing issue reported.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, stent got stuck in the catheter.Confirmed quantity of 01 device, confirmed used.According to the initial report, no adverse effect on the patient has been reported.Investigation findings conclude that a possible root cause could be attributed to the difficult target site which could lead to a stent getting caught up on the delivery system tip, user technique or the suture getting caught up on the bi-lumen causing issue reported.Complaint is confirmed based on customer and/or rep testimony.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 29 may 2025.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick ; IE
• 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: 20985887
• Report Number: 3001845648-2024-00863
• Device Sequence Number: 7760183
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)250104(10)C2013060
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K162717
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 01/04/2025
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C2013060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 50 KG