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

Catalog Number	28-N4-34-154-34U
Medical Device Problem Codes	Device Slipped (1584); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All relevant device history records (dhrs) for the relay pro nbs (n4) thoracic stent-graft system (28-n4-34-154-34u) with final assembly lot# 2301120016, 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) 2023.There were no nonconformances or reworks in relation to this 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 patient underwent a tevar procedure under suspected aneurysm rupture emergency condition; the narrative reports a device migration leading to an endoleak.The physician opted to correct the endoleak by using another competitor device, and the procedure was successfully completed.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 and the root cause determined.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 reported migration and endoleak could not be confirmed.The root cause of the reported failure of migration and suspected endoleak post-procedure could not be determined.
Event or Problem Description
Endoleak (type ib or iiib) a patient in whom the relay pro stent graft was implanted was brought to the hospital due to suspected aorta rupture.Since a type 1b or type 3b caused by migration was suspected based on a ct scan, an emergency tevar was performed.Angiography during the procedure also showed an endoleak flowing into the aneurysm.Therefore, the physician additionally implanted a ctag stent graft (gore).After implanting the ctag stent graft, the endoleak disappeared, and the procedure was successfully completed.Operation type: tevar: no blood loss, no image available due to hospital policy, no pre-case plan available due to hospital policy, no additional information available due to hospital policy, delivery system was discarded by user, ((b)(4)).Patient outcome: "no health hazard to the patient".

• Brand Name: RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
• Common Device Name: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTOON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: manuel benitez ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 25172568
• Report Number: 2247858-2026-00079
• Device Sequence Number: 10566315
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 02/03/2025
• Device Catalogue Number: 28-N4-34-154-34U
• Device Lot Number: 2301120016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown