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

Catalog Number	28-B2-26-080U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"on 26sep2025, the core lab provided a significant finding of stent fracture regarding subject (b)(6) in review of their 3-year x-ray dated on (b)(6) 2025, more specifically a barb break at the proximal aspect of the stent.In comparing the 2-year, the core lab further determined the barb break was already present at 2-year dated on (b)(6) 2024.The report for the 2-year x-ray dated on (b)(6) 2024 did not specify the barb fracture, however the pi confirmed the initial presence at 2-year and seeing it again on the 3-year imaging.Both the 2-year ct dated on (b)(6) 2024 and the 3-year ct dated on (b)(6) 2025 reflected a patent device and no evidence of endoleak.The site reported a device deficiency occurring initially for the 2-year timepoint, and no adverse event occurred as a result of the deficiency." patient outcome: "the subject had their 3-year follow-up on (b)(6) 2025 and resulted in the subject having a ct afterwards (details specified above) due to the imaging quality of the dus being limited by bowel gas.Subject is planned to return in 1-year for their next follow-up.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 2 is being reported under mdr 2247858-2025-00255, and device 3 is being reported under mdr 2247858-2025-00256.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, EDOVASCULAR 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: 23383947
• Report Number: 2247858-2025-00254
• Device Sequence Number: 15614500
• Product Code: MIH
• UDI-Device Identifier: 08435761052357
• UDI-Public: 08435761052357
• 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: 2022
• 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): 10/24/2025

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
• Device Expiration Date: 02/15/2023
• Device Catalogue Number: 28-B2-26-080U
• Device Lot Number: 2101300353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male