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

Catalog Number	28-L2-09-100U
Medical Device Problem Codes	Device Slipped (1584); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with four devices.Device 1 is being reported under mdr-2247858-2025-00090, device 2 is being reported under mdr-2247858-2025-00091, device 3 is being reported under mdr-2247858-2025-00092, and device 4 is being reported under mdr-2247858-2025-00093.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
"(b)(6) had their 3-year follow-up on (b)(6)2025 without any complaints.The ct dated (b)(6)2025 noted a persistent suspected type ii endoleak, confirmed as suspected by the investigator initially, prompting an angio with possible reintervention.The max diameter of lesion was confirmed by the investigator as 55mm, which is the same as the prior 2-year follow-up and <5mm increase compared to 30-day follow-up.The investigator additionally noted a 10mm migration of the device, however it was still deemed patent.The subject was admitted on (b)(6)2025 and underwent angio with reintervention due to what was determined to be a new type ia endoleak by the investigator.A small endoleak on the right posterior aspect of the graft was noted prompting placement of a 30mm terumo aortic cuff (lot: 2402010416) proximally.There were no complications during the procedure.The event was assessed as related to device and index procedure.The investigator further specified there was not a device deficiency nor did the reintervention occur due to a device deficiency." patient outcome: "the subject was discharged on (b)(6)2025 in stable condition, but the event is currently ongoing.Additional site details pending regarding an additional follow-up planned (b)(6) 2025 to discuss post-op ct results from (b)(6)2025.".
Additional Manufacturer Narrative
This complaint was involved with four devices.Device 1 is being reported under mdr-2247858-2025-00090, device 2 is being reported under mdr-2247858-2025-00091, device 3 is being reported under mdr-2247858-2025-00092, and device 4 is being reported under mdr-2247858-2025-00093.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
"(b)(6) had their 3-year follow-up on (b)(6) 2025 without any complaints.The ct dated (b)(6) 2025 noted a persistent suspected type ii endoleak, confirmed as suspected by the investigator initially, prompting an angio with possible reintervention.The max diameter of lesion was confirmed by the investigator as 55mm, which is the same as the prior 2-year follow-up and <5mm increase compared to 30-day follow-up.The investigator additionally noted a 10mm migration of the device, however it was still deemed patent.The subject was admitted on (b)(6) 2025 and underwent angio with reintervention due to what was determined to be a new type ia endoleak by the investigator.A small endoleak on the right posterior aspect of the graft was noted prompting placement of a 30mm terumo aortic cuff (lot: 2402010416) proximally.There were no complications during the procedure.The event was assessed as related to device and index procedure.The investigator further specified there was not a device deficiency nor did the reintervention occur due to a device deficiency." patient outcome: "the subject was discharged on (b)(6) 2025 in stable condition, but the event is currently ongoing.Additional site details pending regarding an additional follow-up planned (b)(6) 2025 to discuss post-op ct results from (b)(6) 2025.".

• 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: 21756271
• Report Number: 2247858-2025-00093
• Device Sequence Number: 18180853
• Product Code: MIH
• UDI-Device Identifier: 08435761052043
• UDI-Public: 08435761052043
• 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,Followup
• Report Date (Section B): 02/27/2026

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: 06/03/2024
• Device Catalogue Number: 28-L2-09-100U
• Device Lot Number: 2105280173
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• 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 Age: 84 YR
• Patient Sex: Female