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

Catalog Number	28-B2-33-080U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"on 13oct2025, the core lab sent notification of a significant finding for subject (b)(6) reflecting a >5mm increase in aneurysm sac size for their 3-year ct imaging dated on (b)(6) 2024 as compared to 30-day dated on (b)(6) 2022.Note that the timepoint/event date for the initial increase may be subject to change, as during the process of the clinical team notifying the site, it was identified that the subject's 2-year ct imaging has not been submitted to the core lab, therefore not yet assessed.Further, the edc database reflects that the 2-year measurements assessed by the investigator was a >5mm increase with an endoleak at that time, while the subject's 3-year data reflects no endoleak and a smaller measurement assessed by the investigator (hence possibility of initial increase at 2-year).Therefore, the core lab will assess the 2-year imaging once submitted by the site, and the core lab will determine if clarification of the imaging timepoint for the >5mm increase finding is appropriate.Site source and further details pending." patient outcome: "site source and further details pending.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported.Device 2 is being reported under mdr-2247858-2025-00265, and device 3 is being reported under mdr-2247858-2025-00266.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): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: manuel benitez ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 23534891
• Report Number: 2247858-2025-00264
• Device Sequence Number: 10074285
• Product Code: MIH
• UDI-Device Identifier: 08435761052388
• UDI-Public: 08435761052388
• 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: 2021
• 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): 11/10/2025

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: 01/23/2023
• Device Catalogue Number: 28-B2-33-080U
• Device Lot Number: 2101150213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2021
• 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: 83 YR
• Patient Sex: Female