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

Catalog Number	28-N4-36-199-36U
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"the device was opened and flushed correctly.I had the physician advance the device to our distal landing zone.He began to advance the inner cannula in position 1.When he began turning the mechanical advantage in the correct direction, it sounded like the internals of the "device" were grinding and breaking.The physician expressed that he could feel "grinding" in the mechanical advantage.I had him immediately remove the device for a new device." patient outcome:"patient was not injured/harmed.No further surgical procedures were required due to the device.We proceeded with the procedure with another relay pro graft that performed perfectly.".
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.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.

• 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 33325 ; 9548389699
• MDR Report Key: 21566751
• Report Number: 2247858-2025-00062
• Device Sequence Number: 21124706
• Product Code: MIH
• UDI-Device Identifier: 00843576150744
• UDI-Public: 00843576150744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P200045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2026

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-N4-36-199-36U
• Device Lot Number: 2501290393
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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
• Patient Age: 36 YR
• Patient Sex: Male