MAUDE Adverse Event Report: Cook Ireland Ltd EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW prosthesis, esophageal

Model Number	G52227
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW prosthesis, esophageal
• Manufacturer (Section D): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 50080062
• Report Number: 3001845648-2026-00308
• Device Sequence Number: 10760272
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)260711(10)C2193256
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Expiration Date: 07/11/2026
• Device Model Number: G52227
• Device Catalogue Number: EVO-FC-20-25-10-E
• Device Lot Number: C2193256
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 121 LB