GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure

Great vessel surgical revascularization procedure is completed, and the endovascular implantation procedure is initiated for the implantation of the TBE Device, without interim death or study discontinuation.

Device Technical Success (index procedure only)

* Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. * Patency of the endovascular aortic and side branch components. * The absence of any unanticipated additional corrective procedure related to the device, procedure, or withdrawal of the delivery system.

Lesion-related mortality

Death meeting at least one of the following characteristics: * Death during the hospitalization or within 30 days following the surgical revascularization procedure. * Death during the hospitalization or within 30 days following the index endovascular procedure or following conversion to open repair. * Death during the hospitalization or within 30 days following a complication from a secondary procedure associated with the index lesion or study device. * Any death where the treated disease / index lesion or study device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.

Disabling Stroke

Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that: * Is identified within 30-days following the surgical revascularization procedure or within 30-days following the index endovascular procedure -AND- * Persists for ≥ 24 hours or until death, or has symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction -AND- * Has an mRS ≥ 2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days post index endovascular procedure.

Access-related complications (index endovascular procedure only)

Complications associated with the access sites used during treatment and any subsequent unplanned access-related reinterventions. This may include pseudoaneurysm, thrombosis, or complications associated with percutaneous closure devices.

Life threatening bleed (index endovascular procedure only)

An event associated with the index endovascular procedure leading to any of the following events as prior to discharge: * Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells within 48 hours of index endovascular procedure. * Cardiac tamponade * Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding * Bleeding requiring intravenous vasoactive drugs * Fatal bleeding is bleeding that directly causes death with no other explainable cause

Stroke

Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that: * Persists for ≥ 24 hours or until death -OR- * Symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction. Disabling stroke will be determined based on mRS ≥ 2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days following the suspected stroke event.

Transient Ischemic Attack (TIA)

Transient focal neurological signs or symptoms (lasting \< 24 h) presumed to be due to focal brain ischemia but without evidence of acute infarction by neuroimaging or pathology (or in the absence of imaging).