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

Catalog Number	28-N4-32-104-32U
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Rupture (2208)
Date of Event	08/23/2024
Type of Reportable Event	Death
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
"aortic aneurysm rupture: tevar was attempted to be performed on the patient with an aortic arch aneurysm with thrombus, planning to place the stent-grafts in zone 2 just below the left common carotid artery (lca).Initially, a 28 mm-104 mm stent-graft was placed distally.No rupture of the aneurysm was observed at this point.The stent graft landed more distally than planned, resulting in the proximal portion of the stent graft being placed without properly apposed against the arch curvature.The stent graft concerned was then attempted to be delivered to the planned implantation site (just below the proximal zone2 and distal to the initial stent graft).However, delivery of the stent graft was difficult, the delivery system tip stressed the aortic arch aneurysm and the aneurysm ruptured during delivery.Due to a sharp drop in blood pressure, implantation of the stent graft was aborted and the stent graft was removed from the patient.A stent-graft (tag 34 mm- 150 mm, gore) was implanted.However, blood pressure did not recover after implantation of the tag stent graft and angiography revealed a type 2 endoleak 2 from the left subclavian artery.Percutaneous cardiopulmonary support (pcps) was started urgently, and repair of the ruptured aneurysm was performed via lateral thoracotomy.Limited view due to lateral thoracotomy might have resulted in secondary lung injury (details unknown as of 23 august).After all repairs were completed, the patient was returned to icu under pcps at a flow rate of 1.5-2.0 l.Physician's comment on health damage: delivery of the stent graft was difficult and stress on the arch aneurysm by the delivery system tip resulted in the rupture of the aneurysm.Although repairs were carried out, self-pressure might have not regained sufficiently.The patient's prognosis is unclear due to secondary lung injury.Physician's comment on causal link: the physician commented that the distal tip of the delivery system stressed the aortic arch aneurysm during delivery and the aneurysm ruptured.Additional information obtained on 27 august: the patient died on the morning of (b)(6) 2024.Regarding lung injury: when approaching the rupture site via lateral thoracotomy, the lung had not been deflated.The treatment of the aorta was performed while avoiding the lung, but the lung was injured.Operation type: tevar blood loss: there was blood loss, but amount is unknown.Image available pre-case plan available additional information will be obtained delivery system was discarded by user (tc#bm (b)(4)".Patient outcome: "the patient died on the morning of (b)(6) 2024.".
Event or Problem Description
"aortic aneurysm rupture: tevar was attempted to be performed on the patient with an aortic arch aneurysm with thrombus, planning to place the stent-grafts in zone 2 just below the left common carotid artery (lca).Initially, a 28 mm-104 mm stent-graft was placed distally.No rupture of the aneurysm was observed at this point.The stent graft landed more distally than planned, resulting in the proximal portion of the stent graft being placed without properly apposed against the arch curvature.The stent graft concerned was then attempted to be delivered to the planned implantation site (just below the proximal zone2 and distal to the initial stent graft).However, delivery of the stent graft was difficult, the delivery system tip stressed the aortic arch aneurysm and the aneurysm ruptured during delivery.Due to a sharp drop in blood pressure, implantation of the stent graft was aborted and the stent graft was removed from the patient.A stent-graft (tag 34 mm- 150 mm, gore) was implanted.However, blood pressure did not recover after implantation of the tag stent graft and angiography revealed a type 2 endoleak 2 from the left subclavian artery.Percutaneous cardiopulmonary support (pcps) was started urgently, and repair of the ruptured aneurysm was performed via lateral thoracotomy.Limited view due to lateral thoracotomy might have resulted in secondary lung injury (details unknown as of 23 august).After all repairs were completed, the patient was returned to icu under pcps at a flow rate of 1.5-2.0 l.Physician's comment on health damage: delivery of the stent graft was difficult and stress on the arch aneurysm by the delivery system tip resulted in the rupture of the aneurysm.Although repairs were carried out, self-pressure might have not regained sufficiently.The patient's prognosis is unclear due to secondary lung injury.Physician's comment on causal link: the physician commented that the distal tip of the delivery system stressed the aortic arch aneurysm during delivery and the aneurysm ruptured.Additional information obtained on 27 august: the patient died on the morning of (b)(6) 2024.Regarding lung injury: when approaching the rupture site via lateral thoracotomy, the lung had not been deflated.The treatment of the aorta was performed while avoiding the lung, but the lung was injured.Operation type: tevar.Blood loss: there was blood loss, but amount is unknown.Image available.Pre-case plan available.Additional information will be obtained.Delivery system was discarded by user.(tc#(b)(4))".Patient outcome: "the patient died on the morning of (b)(6) 2024.".
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.

• 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: 20262814
• Report Number: 2247858-2024-00243
• Device Sequence Number: 15528393
• Product Code: MIH
• UDI-Device Identifier: 00843576150461
• UDI-Public: 00843576150461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/12/2025

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: 01/17/2026
• Device Catalogue Number: 28-N4-32-104-32U
• Device Lot Number: 2312140511
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Female