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

Catalog Number	28-N4-34-209-34U
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
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
"tevar of descending thoracic aorta proximal zone 4 to distal zone 5/proximal zone 6.Patient has previously placed gore tevar in distal zone 4 to mid-distal zone 5.Access gained with 8 fr and pigtail catheter tracked over glidewire into aortic arch.Angiogram and marking landmarks on screen, lunderquist wire advanced through catheter and catheter removed.Relay pro device per ifu.8 fr sheath removed and relay pro device attached into position.Delivery system switched to position 2 and inner curved sheath advanced without issue.Attempted to retract fabric sheath to start uncovering stent graft by turning handle counterclockwise but noticed d marker not moving.Switched back to position 1 and advance the system slightly, switched back to position 2 and depressed button and unsheathed stent without issue.Turned position 3 and tried to disconnect stent but was meeting resistance.A little more effort and stent was detached.Switched to position 4 and nose cone was retracted into outer sheath.Device removed, 18 fr dryseal inserted so that final run could be done which showed good seal proximal and distal and exclusive of aneurysm.Closure with two perclose devices." patient outcome: "patient is doing very well post-op.".

• Brand Name: RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
• Common Device Name: AORTIC, 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: 23512849
• Report Number: 2247858-2025-00268
• Device Sequence Number: 21258863
• Product Code: MIH
• UDI-Device Identifier: 00843576150737
• UDI-Public: 00843576150737
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/19/2026

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 Expiration Date: 02/21/2026
• Device Catalogue Number: 28-N4-34-209-34U
• Device Lot Number: 2402130213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Female