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

Catalog Number	28-N4-34-154-34U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
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 (suspected type iiib) and enlarged aneurysm: a patient who had the relay pro stent-graft implanted on (b)(6) 2024, underwent a follow-up ct scan this month, which revealed an endoleak in the aneurysm and enlargement of the aneurysm.The endoleak was suspected of being type iiib.No endoleak was noted during and after the procedure.The patient will undergo additional tevar this month, using a stent-graft of a different model.Physician's comment on causality: causal relationship with the product cannot be ruled out.Operation type: tevar no blood loss complications: unknown medical history: unknown.No image available due to hospital policy no pre-case plan available due to hospital policy no additional information available due to hospital policy.(tc# (b)(4).Patient outcome: "the patient's outcome is unknown.".
Additional Manufacturer Narrative
All relevant device history records (dhrs) for the relay pro nbs (n4) abdominal stent-graft system (28-n4-34-154-34u) with final assembly lot# 2301240003, 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 january 31, 2023.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, post-procedure ct imaging, and additional information were not available for evaluation due to hospital policy.The narrative reports a suspected type iiib endoleak and enlarged aneurysm at the post procedure follow up.No issues were reported during device implantation and no evidence of endoleak at the time of procedure completion.A type iiib endoleak refers to a tear/hole in the graft fabric; to investigate this reported failure, evaluation of imaging is required to confirm the endoleak and specific location of the fabric's tear.Without pre-op and post-op procedure imaging, the aortic anatomy, sizing, graft selection, device positioning, and evidence of the endoleak could not be confirmed.In conclusion, a review of the device history records showed no issues were found during the manufacture of the device.Without imaging for evaluation, the root cause of the reported failure of suspected 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: 24384018
• Report Number: 2247858-2026-00018
• Device Sequence Number: 10518657
• Product Code: MIH
• UDI-Device Identifier: 00843576150607
• UDI-Public: 00843576150607
• 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): 03/23/2026

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: 01/30/2025
• Device Catalogue Number: 28-N4-34-154-34U
• Device Lot Number: 2301240003
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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