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

Catalog Number	28-M4-40-195-36U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"endoleak (type iiia): stent-graft implementation was performed to treat a descending aortic aneurysm.A stent-graft (28-n4-34-209-34u) was first implemented on the distal side and the stent-graft (28-m4-40-195-36u) was then implemented on the proximal side.Post dilatation was performed, and the procedure was successfully completed.One week after the procedure, however, contrast-enhanced ct revealed a type iiia endoleak.Since the patient is old, the patient is being followed up.If the aneurysm tends to enlarge, additional treatment will be scheduled.Operation type: stent graft implantation blood loss: unknown ancillary device used: 28-n4-34-209-34u.No image available due to hospital policy pre-case plan available (see the attached schema.) additional information will be able to be obtained.(tc# (b)(4).Patient outcome: "no health damage to the patient.".
Additional Manufacturer Narrative
This complaint was involved with two devices.Device 1 is being reported under mdr and device 2 is being reported under mdr-2247858-2024-00261.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 (type iiia): stent-graft implementation was performed to treat a descending aortic aneurysm.A stent-graft (28-n4-34-209-34u) was first implemented on the distal side and the stent-graft (28-m4-40-195-36u) was then implemented on the proximal side.Post dilatation was performed, and the procedure was successfully completed.One week after the procedure, however, contrast-enhanced ct revealed a type iiia endoleak.Since the patient is old, the patient is being followed up.If the aneurysm tends to enlarge, additional treatment will be scheduled.Operation type: stent graft implantation.Blood loss: unknown.Ancillary device used: 28-n4-34-209-34u.No image available due to hospital policy.Pre-case plan available (see the attached schema.) additional information will be able to be obtained.(tc# (b)(6))." patient outcome: "no health damage to the patient.".
Additional Manufacturer Narrative
This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2024-00260 and device 2 is being reported under mdr 2247858-2024-00261.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.

• 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 ; 9548389699
• MDR Report Key: 20465866
• Report Number: 2247858-2024-00260
• Device Sequence Number: 12665565
• Product Code: MIH
• UDI-Device Identifier: 00843576150270
• UDI-Public: 00843576150270
• 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): 03/11/2025

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: 09/05/2025
• Device Catalogue Number: 28-M4-40-195-36U
• Device Lot Number: 2308280202
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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: Other
• Patient Age: 89 YR
• Patient Sex: Male