MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number	28-N4-34-154-30U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
"endoleak: tevar using the relay pro stent-graft was performed on (b)(6) 2024.The patient had no problems after the procedure.However, a follow-up ct scan that was performed a year after the procedure revealed the enlargement of the aneurysm.The type of endoleak is unknown, but the physician suspects it is type 3b.Operation type: tevar (zone 3) no blood loss.Image available (we received a postoperative ct scan.Due to its large file size, koga-san will share the image via a file-sharing service.) pre-case plan available upon request no additional information available due to hospital policy.(tc#(b)(4).Patient outcome: "no damage to the patient's health.".
Additional Manufacturer Narrative
All relevant device history records (dhrs) for the relay pro nbs (n4) thoracic stent-graft system ((b)(6)) with final assembly lot# 2210140005, 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 the device received the required sterilization dose on (b)(6) 2022.There were no nonconformances or reworks in relation to the device.A review of the device history records showed no issues were found during the manufacture of the devices.The pre-case plan in the form of a schema and post-procedure ct imaging were provided for evaluation.Review of the aortic schema confirmed the aortic measurements that determined the graft selection.The patient underwent a tevar procedure on (b)(6) 2024 for treatment of a thoracic aneurysm of 66.0mm in diameter.The access vessels were suitable for advancement and deployment of the device with femoral arteries >8.0mm in diameter for a 21fr device introducer; the physician used the right side as the access side.Review of the post-procedure ct imaging confirmed the aortic measurements in the pre-case plan used to determine the graft selection.The requirements from the relay pro nbs ifu 2844-8324 rev.H and comparison between the selected device and the patient's anatomy is depicted below: component target vessel diameter ifu graft diameter indication graft diameter selected ifu minimum neck length patient's actual neck length comment proximal neck 30.4mm 34.0mm 34.0mm 25mm 30mm proximal neck diameter met the ifu patient and graft selection criteria.Distal neck 27.1mm 30.0mm 30.0mm 20mm 50mm distal neck diameter met the ifu patient and graft selection criteria.Based on the aortic schema analysis, the graft selection (relay pro 28-n4-34-154-30u device) was within the ifu graft selection criteria.There were no issues reported during the advancement and deployment of the device.No endoleaks were observed after procedure completion.The narrative states that a follow-up ct scan 1-year post-procedure, dated (b)(6) 2025, revealed a suspected type iiib endoleak which led to an aneurysm sac enlargement.Review of the post-procedure ct scan imaging shows no evidence of a type ii endoleak due to intercostals branches; the endoleak appears to be localized leading to the determination of type iii endoleak.Evaluation from r&d engineers frank borrego, r&d manager, and michael lee, r&d engineer ii, was provided stating the following: "according to the complaint, the unidentified patient was treated with a relaypro (nbs) device implanted (b)(6) 2024.No issues were reported at the time.On december 4, 2025, it was reported that a follow-up ct scan indicated an enlargement of the patient's aneurysm.As per the complaint, the source of this enlargement is unknown, however the treating physician suggested it may be the result of a type 3b endoleak.As per the complaint form, the device is not being returned for inspection, nor is there any indication the physician intends to explant the device.Durability test engineering team observations: tas r&d's durability test engineering team member michael lee reviewed the provided images taken from the postoperative and follow-up ct scans.Comparison between the postoperative and follow-up images show no discernable migration or repositioning of the sealing stent.The feature shown in red in the follow-up images has been identified as blood, suggesting a potential type 3b endoleak.From the provided images, this feature appears to be located along a distally pointing apex of the second nbs proximal spring, which is partially obscured in the provided images.Without additional imaging (e.G., x-ray) or examination of the device, the integrity of the stent at the anomaly site cannot be confirmed to be free of fractures and the graft fabric cannot be confirmed to be free of a potential breach.The relaypro product line has had the range of its stent types and spiral support strut sizes subjected to various finite element analysis (fea) studies simulating worst-case clinical loads based on published aortic morphology studies to determine worst-case mean and alternating strain (fatigue) loads, followed by a variety of empirical benchtop tests of both integral prostheses and worst-case isolated components' strain 'hot zones' based on those worst-case parameters for cyclic durations equivalent to a minimum of 10 years.The relaypro fatigue test regimens have also included 10-year cyclic duration fatigue tests of the product's graft fabric at hypertensive cyclic tensile loads.Although a classic fatigue-related (cyclic deformation) root cause cannot be conclusively ruled out with the available evidence, one would seem unlikely given the aortic curvature and duration of this prosthesis' implantation.There does appear to be some calcification prevalent along the greater aortic curve (indicated in blue in green in figures 1 - 4), local to (and possibly obstructed by) the apparent endoleak in the ct images, that may have focused exacerbating stress concentrations on the fabric during distension, curvature and/or torsional deformations associated with the cardiac cycle." in conclusion, a review of the device history records showed no issues were found during the manufacture of the device.After evaluation of the provided imaging, the root cause of the reported failure of type iii endoleak found post-procedure could not be determined.

• Brand Name: RELAY PRO NBS THORACIC 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: 23898635
• Report Number: 2247858-2025-00311
• Device Sequence Number: 20080969
• Product Code: MIH
• UDI-Device Identifier: 00843576150966
• UDI-Public: 00843576150966
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/24/2026

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: 10/19/2024
• Device Catalogue Number: 28-N4-34-154-30U
• Device Lot Number: 2210140005
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• 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 Sex: Unknown