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

Catalog Number	28-N4-34-259-34U
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978); Separation Problem (4043)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/11/2024
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
"device was prepped and flushed with 60cc of heparinized saline.No issues were noticed while flushing, no leaks, etc.Device was introduced over a lunderquist wire and advanced in to position.The inner sheath was advanced out of the coiled outer sheath to the proximal landing zone.It was noticed at that time that there was blood coming from the nose cone and flush port area.Case continued without issue and was completed successfully.After the device was withdrawn, the flush port was flushed.The saline seemed to be leaking between the nose cone and the grey stationary grip.It did not appear to be leaking from the flush port or flush port tubing.Type of procedure performed: thoracic stenting to treat type b dissection estimated blood loss: <250 cc.Concomitant medical products: 22fr gore dryseal lunderquist wire".Patient outcome: "reported event did not result in patient injury and/or require medical or surgical intervention.".
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
"device was prepped and flushed with 60cc of heparinized saline.No issues were noticed while flushing, no leaks, etc.Device was introduced over a lunderquist wire and advanced in to position.The inner sheath was advanced out of the coiled outer sheath to the proximal landing zone.It was noticed at that time that there was blood coming from the nose cone and flush port area.Case continued without issue and was completed successfully.After the device was withdrawn, the flush port was flushed.The saline seemed to be leaking between the nose cone and the grey stationary grip.It did not appear to be leaking from the flush port or flush port tubing.Type of procedure performed: thoracic stenting to treat type b dissection estimated blood loss: <250 cc concomitant medical products: 22fr gore dryseal lunderquist wire." patient outcome: "reported event did not result in patient injury and/or require medical or surgical intervention.".

• 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: 21073408
• Report Number: 2247858-2025-00009
• Device Sequence Number: 8498239
• Product Code: MIH
• UDI-Device Identifier: 00843576150867
• UDI-Public: 00843576150867
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 11/16/2025
• Device Catalogue Number: 28-N4-34-259-34U
• Device Lot Number: 2311100113
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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
• Patient Sex: Unknown