MAUDE Adverse Event Report: BOLTON MEDICAL, INC TREO ABDOMINAL STENT-GRAFT SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	28-B2-26-120U
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Graft was opened and modified.Difficulty resheathing graft.

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL, INC; 799 international pkwy; sunrise FL 33325
• MDR Report Key: 22436178
• Report Number: 22436178
• Device Sequence Number: 17291488
• Product Code: MIH
• UDI-Device Identifier: 00843576152519
• UDI-Public: (01)00843576152519(11)240411(17)270411(10)2404080121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025
• Report Date (Section F): 07/01/2025

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: Other
• Device Model Number: 28-B2-26-120U
• Device Catalogue Number: 28-B2-26-120U
• Device Lot Number: 2404080121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Date Report Sent to FDA: 07/01/2025