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

Catalog Number	28-N4-46-209-46U
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"an extension procedure was planned but not at the same time as the thoraflex hybrid.Thoraflex hybrid was implanted on (b)(6) 2024.No distal seal was intended due to a planned evar extension and distal seal was obtained.No endoleak was present at the end of the procedure.Delivery of the thoraflex hybrid was successful, deployed in planned location and withdrawal of delivery system was successful.No device deficiencies occurred during the index th procedure.Patient received a extension on (b)(6) 2024.A relay pro nbs was implanted.The procedure was endovascular - tevar and right groin cutdown.A type ib endoleak was present at the end of the procedure - this was intentional.No device deficiencies occurred during the procedure.Delivery of the stent graft was successful, deployed in planned location and withdrawal of delivery system was successful.Event details: aneurysm expansion a follow up ct chest/abdomen/pelvis showing aneurism expansion to 8.9cm (after nbs extension procedure)." patient outcome: "surgical procedure carried out - tevar, 4 vessel pmeg, evar.Ae is ongoing, unresolved still treating and the subject remains in the study.".
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
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
"an extension procedure was planned but not at the same time as the thoraflex hybrid.Thoraflex hybrid was implanted on (b)(6) 2024.No distal seal was intended due to a planned evar extension and distal seal was obtained.No endoleak was present at the end of the procedure.Delivery of the thoraflex hybrid was successful, deployed in planned location and withdrawal of delivery system was successful.No device deficiencies occurred during the index th procedure.Patient received a extension on (b)(6) 2024.A relay pro nbs was implanted.The procedure was endovascular - tevar and right groin cutdown.A type ib endoleak was present at the end of the procedure - this was intentional.No device deficiencies occurred during the procedure.Delivery of the stent graft was successful, deployed in planned location and withdrawal of delivery system was successful.Event details - aneurysm expansion a follow up ct chest/abdomen/pelvis showing aneurism expansion to 8.9cm (after nbs extension procedure)." patient outcome: "surgical procedure carried out - tevar, 4 vessel pmeg, evar.Ae is ongoing, unresolved still treating and the subject remains in the study.".

• 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: 20075638
• Report Number: 2247858-2024-00220
• Device Sequence Number: 3024194
• Product Code: MIH
• UDI-Device Identifier: 00843576150799
• UDI-Public: 00843576150799
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/19/2025

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 Expiration Date: 12/06/2024
• Device Catalogue Number: 28-N4-46-209-46U
• Device Lot Number: 2211300190
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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: 48 YR
• Patient Sex: Male