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

Catalog Number	28-M4-44-200-40U
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Failure to Seal (4070); Device Endoleak (4074)
Health Effect - Clinical Codes	Insufficient Information (4580); Clinical Endoleak (4843)
Date of Event	12/10/2024
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
"endoleak (type1a): only two-debranching procedure was performed the day before tevar and only tevar was performed on (b)(6).As per the standard procedure, 28-n4-36-109-36u (2310160270) was implanted peripherally and the relaypro concerned was attempted to be implanted centrally from just below the bca.The relaypro was implanted, but it could not be sufficiently confirmed whether the bca was completely covered with the relaypro or not.The final angiography showed no leaks, and the procedure was successfully completed.However, on (b)(6), a leak was confirmed on post-operative angiography.The physician also suspected a type 3b endoleak, but when the physician checked the actual implantation site, the relaypro was implanted not just below the bca, but where it covered half of the lcca.There is a possibility that an additional tevar will be performed, but this is still undecided at this time.Operation type: tevar after 2 debranching.Ancillary device: 28-n4-36-109-36u (2310160270).Blood loss: small amount.Image available upon request.Pre-case plan available: schema attached.Additional information available upon request.(tc#:(b)(4)".Patient outcome: "no health damage to the patient.".
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
"endoleak (type1a): only two-debranching procedure was performed the day before tevar and only tevar was performed on (b)(6).As per the standard procedure, 28-n4-36-109-36u (2310160270) was implanted peripherally and the relaypro concerned was attempted to be implanted centrally from just below the bca.The relaypro was implanted, but it could not be sufficiently confirmed whether the bca was completely covered with the relaypro or not.The final angiography showed no leaks, and the procedure was successfully completed.However, on december 10, a leak was confirmed on post-operative angiography.The physician also suspected a type 3b endoleak, but when the physician checked the actual implantation site, the relaypro was implanted not just below the bca, but where it covered half of the lcca.There is a possibility that an additional tevar will be performed, but this is still undecided at this time.Operation type: tevar after 2 debranching.Ancillary device: 28-n4-36-109-36u (2310160270).Blood loss: small amount.Image available upon request.Pre-case plan available: schema attached.Additional information available upon request.(tc#(b)(4))".Patient outcome: "no health damage to the patient.".

• Brand Name: RELAY PRO 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
• MDR Report Key: 21091868
• Report Number: 2247858-2025-00008
• Device Sequence Number: 9155120
• Product Code: MIH
• UDI-Device Identifier: 00843576150294
• UDI-Public: 00843576150294
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/10/2025

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: 05/30/2026
• Device Catalogue Number: 28-M4-44-200-40U
• Device Lot Number: 2405170344
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown