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

Catalog Number	28-L2-20-100U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2026-00065 and device 3 is being reported under mdr-2247858-2026-00067.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
I was made aware last night of an explant of a treo device, physician stated there was type 3 endoleak and the decision was made to explant the device.No further details were provided.Additional information received on (b)(6) 2026 from the terumo aortic site representative: at the time of implant bilateral renal accessories were embolized.Post implant angiogram revealed successful exclusion of aneurysm without evidence of endoleak.A ct performed on (b)(6) 2021 showed a possible type 2 endoleak "likely due to a non-embolized accessory left renal", sac was stable.He had multiple interventions for a type 2 endoleak which led to a laparoscopic ligation of ima and multiple lumbars on (b)(6) 2024.He had a cv mra on (b)(6) 2025 that showed sac 7.2 cm, the report also stated "right common iliac- distal segment is ectatic, the iliac limb of aortoiliac stent graft extends into the common iliac artery.Incomplete apposition of the distal end of the stent graft." explant performed 03/28/2026.On the op report it states 'significant bleeding was noted from a defect in the graft from the posterior main body.Patient outcome: "no info provided on patient.Additional information received on (b)(6) 2026 from the terumo aortic site representative: to my limited knowledge, the patient is doing well.".

• 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: 24967241
• Report Number: 2247858-2026-00066
• Device Sequence Number: 10363806
• Product Code: MIH
• UDI-Device Identifier: 00843576152090
• UDI-Public: 00843576152090
• 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
• Device Explanted Year: 2026
• 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): 04/23/2026

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: 02/03/2024
• Device Catalogue Number: 28-L2-20-100U
• Device Lot Number: 2101230236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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; Required Intervention
• Patient Sex: Male