Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.

Additional unanticipated surgical procedure or endovascular procedure related to TBE, TBE implant procedure, or revascularization procedure for TBE implant after the revascularization procedure or TBE implant procedure.

Anticipated or unanticipated status will be determined at the discretion of the investigator.

Surgical procedures include conversion to thoracotomy. Endovascular procedures include stent graft implants for endoleaks, aortic enlargement and loss of patency, and procedures on the branch to improve or restore patency.

Events will not include access site(s) complications, interventions to address issues related to non-treated area of the index lesion, such as bare stent implant to address bowel ischemia associated with aortic dissection.

Ischemia reported by sites as a serious adverse event determined to be related to the device.

Device-related ischemic adverse events reported by sites as serious adverse events that required bypass surgery, surgical procedures, or amputation, or that resulted in death.

New events of aortic dissection reported as serious adverse events by sites.

Myocardial infarction reported as a serious adverse event by the sites.

Nerve damage events reported by the sites as serious adverse events that required retreatment.

Heart failure or hypotension reported as serious adverse events by the sites.

An increase of 5 mm or more in arterial diameter at the treated area compared to images taken at the first follow-up after the TBE implant procedure.

Serious adverse events reported or confirmed by imaging by the sites.

The definitions of each type of endoleaks are as follows:

• Type I endoleak is defined as a sealing failure at one of the attachment sites of the graft to the vessel wall. Arterial flow therefore leaks alongside the graft and into the perigraft space.
• Type Ia: Proximal leak
• Type Ib: Distal leak
• Type Ic: Inadequate seal at distal landing zone for side branch component
• Type II endoleak is defined as retrograde flow from branch arteries arising from the treated segment of the aorta.
• Type III endoleak
• Type IIIA endoleak : Attachment of aortic components (aortic-aortic).
• Type IIIB endoleak : Fabric tear or disruption.
• Type IIIC endoleak : Attachment of aortic component-side-branch or side-branch-side-branch
• Type IV endoleak is defined as flow through porous fabric.
• Indeterminate : Endoleak detected with unknown source.

Defined as any of the following:

• Wire fractures identified in the sealing row stents of the aortic component (AC), branch component (SB) or aortic extender (AE).
• Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow
• Disruption / tears in the graft component of the stent graft
• Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic or branch vessel luminal diameter.
• If the device loses function due to other malformations

No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the TBE implant procedure.

Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by imaging, relative to anatomical landmarks and device positioning at the first post-operative imaging.

Confirm the presence or absence of blood flow from a proximal aortic source through the primary entry tear into the aortic false lumen, based on imaging.

Among the aortic dissections reported by sites as serious adverse events, those in which proximal or distal progression of the lesion from the TBE implant procedure was confirmed on imaging.

The thrombosis state of the false lumen at the treated and untreated segments at the TBE implant procedure is confirmed using the following three stages.

• Patent is defined as flow present throughout the aortic false lumen in the absence of evidence of thrombus.
• Partially thrombosed false lumen is defined as clot within the aortic false lumen that has a residual patent flow channel.
• Thrombosed false lumen is defined as complete thrombosis of the aortic false lumen.