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

Catalog Number	28-L2-17-080U
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Stenosis (2263); Restenosis (4576)
Date of Event	10/15/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2025-00083, device 2 is being reported under mdr-2247858-2025-00084, and device 3 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
"on 28feb2025, the core lab sent notification of significant finding for subject (b)(6) of stenosis in the proximal graft for 3-year imaging dated (b)(6) 2024 and unscheduled imaging dated (b)(6) 2024.The unscheduled imaging was obtained during the same hospitalization for the initial >5mm increase noted on their late 2-year imaging." patient outcome: "the subject was hospitalized again and death occurred on (b)(6) 2024 due to septic shock unrelated to the study.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2025-00083, device 2 is being reported under mdr-2247858-2025-00084, and device 3 is being reported under mdr-2247858-2025-00085.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
"on 28feb2025, the core lab sent notification of significant finding for subject (b)(6) of stenosis in the proximal graft for 3-year imaging dated (b)(6) 2024 and unscheduled imaging dated (b)(6) 2024.The unscheduled imaging was obtained during the same hospitalization for the initial >5mm increase noted on their late 2-year imaging that resulted in a re-intervention.(complaint (b)(4)).Both ct reports note thrombus along the posterior wall of the abdominal aorta propagating into the proximal left renal artery resulting in 80% stenosis with the (b)(6) 2024 ct report further specifying the thrombus in the stent graft.On 06mar2025, the investigator re-reviewed the imaging stating "there is not significant stenosis in the graft.It appears widely patent.I see no issues with the device.None of this is device related".Therefore, there was no adverse event that occurred." patient outcome: "the subject was discharged (b)(6) 2024 after their re-intervention hospitalization resulted in a prolongation due to the subject developing acute cholecystitis.On 06mar2025, the investigator confirmed that the cholecystitis was likely not reintervention related.The subject was hospitalized again due to complications from his cholecystitis resulting in septic shock and then non-study related death occurred on (b)(6) 2024.".

• 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: matthew cleary ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 21643512
• Report Number: 2247858-2025-00085
• Device Sequence Number: 12668633
• Product Code: MIH
• UDI-Device Identifier: 08435761052012
• UDI-Public: 08435761052012
• 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): 05/30/2025

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: 01/21/2024
• Device Catalogue Number: 28-L2-17-080U
• Device Lot Number: 2101120079
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2021
• 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; Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male