The Fibrin Pad CV Phase III Study

Inclusion Criteria:

- Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical
procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20
years of age will require consent by the subject's legal representative

- Subjects must be willing to participate in the study and provide written informed
consent.

- Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture
line, involving a synthetic aortic graft, as identified intra-operatively by the
investigator;

Exclusion Criteria:

- Subjects with known intolerance to blood products or to one of the components of the
study product or unwilling to receive blood products;

- Exposure to another investigational drug or device in a clinical trial within 30 days
prior to surgery or anticipated in the 60 day follow up period after surgery.

- Female subjects who are pregnant or nursing.

- TBS is from a large defects in visible arteries or veins where the injured vascular
wall requires repair and maintenance of vessel patency or where there would be
persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure
during absorption of the product;

- TBS with major arterial bleeding requiring suture or mechanical ligation;

- TBS involves an expanded polytetrafluoroethylene (ePTFE) graft

- TBS within an actively infected field;

- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
confine;

- Subjects with any intra-operative findings identified by the investigator that may
preclude conduct of the study procedure;