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

Catalog Number	28-N4-24-159-24S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
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 performed on (b)(6) 2024 with a relaypro nbs (catalogue and lot number as provided on page 1 of event form) and a gore c-tag with active control (catalogue number tgm262610, serial number (b)(6)).On post operative day 239 ((b)(6) 2024) from extension procedure, (246 days post operative from index procedure), the patient experienced worsening thoracoabdominal aorta dissection.There was increasing dilation of downstream residually dissected thoracoabdominal aorta and bilateral common iliac arteries.There is a planned 2 stage hybrid repair: stage 1 - infrarenal aorta-bi-iliac replacement with abdominal debranching.Stage 2 - completion tevar (interpreted as thoracic endovascular aortic repair).On (b)(6) 2025, planned major open surgery was performed: an aorto-bi-iliac bypass with debranching of visceral vessels (ilio-coeliac, ilio-sma (interpreted as superior mesenteric artery), ilio-ima (interpreted as inferior mesenteric artery), ilio-renal (left renal, right renal).The site have documented in edc that the intervention required was not as a result of a device deficiency but did result in the implantation of a new device.The device information section is blank in the edc system at time of reporting.Concomitant medications (taken at the time of the event) as per edc include: warfarin, aspirin and metoprolol succinate.The site have documented in the electronic data capture (edc) system that the event was anticipated, not related to the procedure, not related to the device with no device deficiency, but related to a pre-existing condition.However, the medical monitor on reviewing the event has deemed the event to be possibly related to the device and related to the relay stent graft." patient outcome: "the event is ongoing, unresolved and patient is still being treated.The patient 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.
Event or Problem Description
"an extension procedure was performed on (b)(6) 2024 with a relaypro nbs (catalogue and lot number as provided on page 1 of event form) and a gore c-tag with active control (catalogue number tgm262610, serial number (b)(6)).On post operative day 239 ((b)(6) 2024) from extension procedure, (246 days post operative from index procedure), the patient experienced worsening thoracoabdominal aorta dissection.There was increasing dilation of downstream residually dissected thoracoabdominal aorta and bilateral common iliac arteries.There is a planned 2 stage hybrid repair: stage 1 - infrarenal aorta-bi-iliac replacement with abdominal debranching.Stage 2 - completion tevar (interpreted as thoracic endovascular aortic repair).On (b)(6) 2025, planned major open surgery was performed: an aorto-bi-iliac bypass with debranching of visceral vessels (ilio-coeliac, ilio-sma (interpreted as superior mesenteric artery), ilio-ima (interpreted as inferior mesenteric artery), ilio-renal (left renal, right renal).The site have documented in edc that the intervention required was not as a result of a device deficiency but did result in the implantation of a new device.The device information section is blank in the edc system at time of reporting.Concomitant medications (taken at the time of the event) as per edc include: warfarin, aspirin and metoprolol succinate.The site have documented in the electronic data capture (edc) system that the event was anticipated, not related to the procedure, not related to the device with no device deficiency, but related to a pre-existing condition.However, the medical monitor on reviewing the event has deemed the event to be possibly related to the device and related to the relay stent graft." patient outcome: "the event is ongoing, unresolved and patient is still being treated.The patient 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: manuel benitez ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 21396859
• Report Number: 2247858-2025-00040
• Device Sequence Number: 18038806
• Product Code: MIH
• UDI-Device Identifier: 00843576150553
• UDI-Public: 00843576150553
• 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): 01/08/2026

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: 09/11/2025
• Device Catalogue Number: 28-N4-24-159-24S
• Device Lot Number: 2308020124
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 31 YR
• Patient Sex: Female