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 Codes	Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"leakage of blood from the controller: the relay pro stent graft was used for tevar.During insertion of the delivery system into the artery, blood leakage was observed on the left side of the controller.As the amount of blood leakage was small (only a slight drop), it was determined that the leakage did not affect either the procedure or the patient.There was no problem with the use of the stent graft itself.The procedure was then successfully completed.Operation type: tevar blood loss: unknown ancillary device used: 28-n4-32-164-32u.No image available due to hospital policy pre-case plan available upon request no additional information available due to hospital policy.(tc#(b)(4)).Patient outcome: "no health damage to the patient.".
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.A review of the device history records showed no issues were found during the manufacture of the device.The device was not returned for investigation.As indicated in the narrative, additional information was not available due to hospital policy.As indicated in the narrative, the patient underwent a tevar procedure in which a relay pro nbs device was implanted.During insertion of the delivery system into the entry vessel, it was observed that a small amount of blood was leaking from the controller knob.The procedure was completed successfully, and no harm was reported to the patient.Without the return of the delivery system or additional information, it is not possible to determine the root cause of the reported failure of loss of hemostasis.Without the return of the device, the root cause of the reported failure of loss of hemostasis 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: matthew cleary ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 22036172
• Report Number: 2247858-2025-00126
• Device Sequence Number: 20873089
• 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: 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): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 28-N4-34-154-34U
• Device Lot Number: 2502240415
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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: 82 YR
• Patient Sex: Male