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

Catalog Number	28-L2-15-160U
Medical Device Problem Codes	Failure to Seal (4070); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"the core lab sent notification of a significant finding on (b)(6) 2025 for subject (b)(6) regarding a >5mm increase sac enlargement for 2-year imaging dated (b)(6) 2024 as compared to the 30-day imaging.The 2-year ct was non-constrast, therefore the core lab also used the recent 3-year ct with/without contrast for comparison of continued growth as noted on the finding.Pending site details" patient outcome: "pending site details".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2025-00130, device 2 is being reported under mdr-2247858-2025-00131, and device 3 is being reported under mdr-2247858-2025-00132.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.
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under(b)(4), device 2 is being reported under (b)(4), and device 3 is being reported under (b)(4).All relevant device history records (dhrs) for the treo bifurcate (b2) abdominal stent-graft system - device 1 (28-b2-33-080u) with final assembly lot# 2009110180, treo limb extension (l2) abdominal stent-graft system - device 2 (28-l2-15-160u) with final assembly lot# 2204300027, and treo limb extension (l2) abdominal stent-graft system - device 3 (28-l2-13-140u) with final assembly lot# 2105170230, including final assembly (labeling), stent-graft system/packaging, delivery system assembly and stent-graft assembly, were inspected and no discrepancies were found.No discrepancies were noted in the qc inspections performed within the corresponding sub-assembly and final assembly processes.Sterilization records show device 1 received the required sterilization dose on (b)(6) , 2020, device 2 received the required sterilization dose on (b)(6) , 2022, and device 3 received the required sterilization dose on (b)(6) , 2021.There were no nonconformances or reworks in relation to device 1, 2, or 3.The patient underwent an endovascular aortic repair (evar) procedure on (b)(6) , 2022, in which a treo bifurcate (catalog # 28-b2-33-080u) stent-graft and two treo leg (catalog # 28-l2-15-160u, 28-l2-13-140u) stent-grafts were implanted to treat an abdominal aneurysm.The event narrative indicated an aneurysm sac enlargement of >5mm from the 30-day post-operative ct scan, the 2-year ct scan, and the 3-year ct scan.An update provided by the site on (b)(6) , 2025, mentioned a persistent type ii endoleak was observed in the two-year and three-year follow-up ct imaging.A review of the device history records showed no issues were found during the manufacture of the devices.The ct imaging (pre-operative and post-operative) was provided.Table 1 identifies the requirements from the treo (b)(4) rev.B and compares it with the device selected and the patient's anatomy.Table 1.Comparison between requirements in ifu, device selected, and patient anatomy.Component target vessel diameter ifu graft diameter indication proximal graft diameter selected ifu minimum neck length patient's actual neck length comment bifurcate 28.6mm 33mm 33mm 15mm 36mm infrarenal neck diameter and length oversizing met the ifu patient selection criteria.The ct imaging was reviewed.The pre-operative aneurysm sac size was measured to be approximately 57.7 mm.A post-operative angiogram performed on (b)(6) , 2022, was provided in which no endoleaks were observed.The ct scans dated (b)(6) , 2022, showed an aneurysm sac size of approximately 59.3 mm.The ct scan performed on (b)(6) , 2023, showed ongoing disease progression as the aneurysm sac diameter was measured to be approximately 62.8 mm.The reported failure was confirmed, as the 3-year follow-up ct scans dated (b)(6) , 2025, showed an aneurysm sac size of approximately 69.5 mm.The aneurysm sac enlargement from the 30-day ct scan to the 3-year ct scan was measured to be approximately 10 mm.The reported persistent type ii endoleak was confirmed in the 30-day post-operative ct scan, and in the one-year follow-up ct scan.The 30-day post-op and one-year post-op ct scan did not include contrast so the endoleak might not have been initially observed at the time by the site.Multiple type ii endoleaks were observed in the three-year follow-up ct scans, both near the proximal end of the stent-graft and at the region of bifurcation.The multiple type ii endoleaks likely became more evident since contrast was used during the three-year follow-up ct scan.Within each post-operative ct scan reviewed, the type ii endoleak was evident as the lumbar arteries were observed to feed the aneurysm sac, causing the aneurysm enlargement between each ct scan performed on the patient.An aortic aneurysm, by definition, is a progressive disease that will generally grow over time and may not have any symptoms (asymptomatic) in the beginning.The endovascular "repair" procedure does not heal the vessel from the atherosclerotic disease but reinforces the aortic wall and creates a "bypass" through which the blood can flow, without touching the aortic wall, to prevent the aneurysm from rupturing or to seal a rupture aneurysm.So, if the atherosclerotic disease allows the aneurysm to form, it also allows the radial load of the stent-graft to stretch the aortic wall.In conclusion, a review of the device history records showed no issues were found during the manufacture of the devices.The root cause of the reported failure mode of post-implant aortic disease progression was the persistent type ii endoleak.The root cause of the type ii endoleak was the lumbar arteries feeding the aneurysm sac.Type ii endoleaks are not device related.Endoleaks are known adverse events of evar procedures.

• 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: 22100140
• Report Number: 2247858-2025-00131
• Device Sequence Number: 20921228
• Product Code: MIH
• UDI-Device Identifier: 00843576152281
• UDI-Public: 00843576152281
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 05/05/2025
• Device Catalogue Number: 28-L2-15-160U
• Device Lot Number: 2204300027
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2022
• 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: 74 YR
• Patient Sex: Male