MAUDE Adverse Event Report: BOLTOON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number	28-L2-20-080U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"on 11may2026, the core lab sent notification of a significant finding regarding >5mm growth of subject's aorta at proximal aspect of the stent for their 3-year ct dated (b)(6) 2025 in comparison to the 30-day timepoint.The investigator reviewed the finding and subject's imaging and did not agree with the core lab's assessment, specifying the following: "subject has no change in the aortic neck from implantation.Measurement of the neck on the axial image attached overcalls the diameter that is indeed aneurysmal at the top of the uncovered struts of the treo graft.There is angulation that is making that diameter larger than it really is and is best seen in the sagittal view for measurement.On direct comparison of the initial and most recent ct, there is no change in the neck at the top of the uncovered struts or at the short ring like seal zone of the neck since implantation.No further action is required." the csm inquired afterwards with the core lab regarding the site's assessment, and core lab specified that per their core lab pi "proximal aortic growth is present in the proximal aspect of the stent but still appears to have seal with minimal graft movement".The core lab also clarified "that our initial measurements that triggered a further look into growth are done in a centerline view which accounts for any angulation, etc.".' patient outcome: "subject was doing well as of their 3-year follow-up and there is no new clinical information since that visit.Subject discussed hesitations to complete any further follow-ups for the study at that visit, so the site plans to contact her leading up to the next follow-up in hopes to still obtain additional follow-ups/imaging".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2026-00092, device 2 is being reported under, and device 3 is being reported under mdr-2247858-2026-00094.Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Common Device Name: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTOON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: manuel benitez ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 25416062
• Report Number: 2247858-2026-00093
• Device Sequence Number: 5726076
• Product Code: MIH
• UDI-Device Identifier: 08435761052029
• UDI-Public: 08435761052029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/25/2024
• Device Catalogue Number: 28-L2-20-080U
• Device Lot Number: 2105170360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Female