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

Catalog Number	28-L2-20-080U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with four devices.Device 1 is being reported under mdr-2247858-2025-00320, device 2 is being reported under mdr-2247858-2025-00321, device 3 is being reported under mdr-2247858-2025-00322, and device 4 is being reported under mdr-2247858-2025-00323.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.
Event or Problem Description
"subject (b)(6) had their 3-year follow-up on (b)(6) 2024 with the pi confirming that their ct dated (b)(6) 2024 reflected a >5mm increase in aneurysm measuring 74mm as compared to the 30-day ct dated (b)(6) 2022 with a measurement of 64mm (10mm increase overall).Through 2-year follow-up the subject's aneurysm has remained stable; however, they have had a type iia endoleak since the 1-year follow-up that did not worsen until 3-year follow-up." patient outcome: "event is ongoing and no action has been taken to date, therefore no serious criteria met.The subject had their 4-year follow-up on (b)(6) 2025 with the max aneurysm diameter remaining stable with an investigator measurement of 74.8mm.The investigator confirmed that there are no plans to intervene at this time.".
Additional Manufacturer Narrative
This complaint was involved with four devices.Device 1 is being reported under mdr-2247858-2025-00320, device 2 is being reported under mdr-2247858-2025-00321, device 3 is being reported under mdr-2247858-2025-00322, and device 4 is being reported under mdr.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.
Event or Problem Description
"subject (b)(6) had their 3-year follow-up on 03dec2024 with the pi confirming that their ct dated (b)(6) 2024 reflected a >5mm increase in aneurysm measuring 74mm as compared to the 30-day ct dated (b)(6) 2022 with a measurement of 64mm (10mm increase overall).Through 2-year follow-up the subject's aneurysm has remained stable; however, they have had a type iia endoleak since the 1-year follow-up that did not worsen until 3-year follow-up." patient outcome: "event is ongoing and no action has been taken to date, therefore no serious criteria met.The subject had their 4-year follow-up on 28oct2025 with the max aneurysm diameter remaining stable with an investigator measurement of 74.8mm.The investigator confirmed that there are no plans to intervene at this time.".

• 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: 24067095
• Report Number: 2247858-2025-00324
• Device Sequence Number: 21114778
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 02/24/2024
• Device Catalogue Number: 28-L2-20-080U
• Device Lot Number: 2102170219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2021
• 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: 67 YR
• Patient Sex: Male