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

Catalog Number	28-M4-34-145-34U
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with two devices.Device 2 is being reported under mdr-2247858-2024-00342.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 (minor type ia endoleak remained): only 2-debranching was performed on november 15, and tevar was then performed on november 22.As the access artery could not be punctured due to its poor condition, a cut-down method was used instead.Tevar was then performed as usual.As a 200 mm long stent-graft would be too long, two 150 mm long stent-grafts were used.The stent-graft concerned (28-m4-34-145-34u, lot#2406220121) was first implanted from right under zone 1, and the second stent-graft (28-m4-34-145-34u, lot#2407190457) was then implanted right above a descending thoracic aortic aneurysm on the distal side.The final angiography revealed a type ia endoleak.After careful post dilatation, another angiography confirmed that a slight type ia endoleak remained.Since the descending thoracic aortic aneurysm on the distal side is going to be treated in the near future, this procedure was completed and the patient was to be followed up.Additional information obtained on november 27: contrast-enhanced ct confirmed on november 26 that the endoleak had disappeared.Operation type: 2-debranching tevar.Blood loss: unknown.No image available due to hospital policy.Pre-case plan available (see the attached schema).Additional information will be able be obtained.(tc# (b)(4) )." patient outcome: "no health damage to the patient.".
Event or Problem Description
"endoleak (minor type ia endoleak remained): only 2-debranching was performed on november 15, and tevar was then performed on november 22.As the access artery could not be punctured due to its poor condition, a cut-down method was used instead.Tevar was then performed as usual.As a 200 mm long stent-graft would be too long, two 150 mm long stent-grafts were used.The stent-graft concerned (28-m4-34-145-34u, lot#2406220121) was first implanted from right under zone 1, and the second stent-graft (28-m4-34-145-34u, lot#2407190457) was then implanted right above a descending thoracic aortic aneurysm on the distal side.The final angiography revealed a type ia endoleak.After careful post dilatation, another angiography confirmed that a slight type ia endoleak remained.Since the descending thoracic aortic aneurysm on the distal side is going to be treated in the near future, this procedure was completed and the patient was to be followed up.Additional information obtained on november 27: contrast-enhanced ct confirmed on november 26 that the endoleak had disappeared operation type: 2-debranching tevar.Blood loss: unknown.No image available due to hospital policy.Pre-case plan available (see the attached schema).Additional information will be able 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-2247858-2024-00328 and device 2 is being reported under mdr-2247858-2024-00342.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: 20989433
• Report Number: 2247858-2024-00328
• Device Sequence Number: 8466734
• Product Code: MIH
• UDI-Device Identifier: 00843576149786
• UDI-Public: 00843576149786
• 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): 04/02/2025

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: 06/30/2026
• Device Catalogue Number: 28-M4-34-145-34U
• Device Lot Number: 2406220121
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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: Other
• Patient Sex: Unknown