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

Catalog Number	28-N4-32-164-28U
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"dissection: on (b)(6) 2025, the relay pro stent-graft (nbs) was implanted for emergency type b dissection.Although the patient had no symptoms after the procedure, follow-up contrast-enhanced ct on (b)(6) revealed retrograde type a aortic dissection (rtad) with an entry at the lesser curvature around the proximal end of the stent-graft.Emergency tar-fet using a frozenix (japan lifeline) was then performed.Physician's comment: as the stent-graft is not oversized for the native vessel, the physician does not known why rtad occurred.Operation type: tevar blood loss: 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: "health damage to the patient is unknown.".
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.
Additional Manufacturer Narrative
During an internal review, bolton medical, inc.Determined that the applicable standard operating procedure did not clearly define the reporting timelines for supplemental mdrs.We have initiated corrective actions to address this gap and will be documented in our quality system under capa-2026-0002.All relevant device history records (dhrs) for the relay pro nbs (n4) thoracic stent-graft system (28-n4-32-164-28u) with final assembly lot# 2409260203, 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 october 15, 2024.There were no nonconformances or reworks in relation to this device.Review of the device history records showed no issues were found during the manufacture of the device.As stated in the narrative, the pre-case plan and ct images are not available due to hospital policy.The patient underwent an emergency tevar procedure with a relay pro nbs device (28-n4-32-164-28u) to treat a thoracic type b dissection on (b)(6) 2025.There were no issues reported during the advancement and deployment of the device.However, a follow-up ct scan showed a type a dissection - retrograde type a aortic dissection (rtad) with an entry at the proximal end of the stent-graft.A retrograde type a aortic dissection is a rare but potentially catastrophic complication.The physician opted to perform a frozen elephant trunk (fet) technique which can facilitate the distal anastomosis of total arch replacement (tar); the technique is increasingly being used in tar cases.Without the ct imaging, the full assessment of the patient's anatomy, sizing, graft selection and device positioning, and post procedure evaluation could not be performed and thus the cause of the rtad could not be determined.In conclusion, a review of the device history records showed no issues were found during the manufacture of the device.With the limited information provided, the root cause of the reported failure of type b and type a dissection (rtad) 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: 23884489
• Report Number: 2247858-2025-00305
• Device Sequence Number: 9464891
• Product Code: MIH
• UDI-Device Identifier: 00843576150959
• UDI-Public: 00843576150959
• 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: 2025
• 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): 04/08/2026

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 Catalogue Number: 28-N4-32-164-28U
• Device Lot Number: 2409260203
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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