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INDICATIONS The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm
WHAT ARE THE POTENTIAL RISKS AND COMPLICATIONS? Treatment options for CAD have become increasingly common but, as with any invasive procedure, there are potential risk factors and complications. Serious complications do not occur often, and research is ongoing to make these procedures even safer and more effective. The risk of complications from percutaneous treatment methods may be higher for individuals:
75 years of age and older
Who are women
Who have kidney disease or diabetes
Who have serious heart disease
Who have had prior cardiac interventions
POTENTIAL RISKS Listed below are known potential risks that may occur to you during or after placement of the Absorb GT1 BVS. These risks are not specific to the Absorb GT1 BVS device and may occur with any similar coronary artery stent:
Allergic reaction or hypersensitivity to rubber, contrast agent, anesthesia, device materials (platinum, polymer), and everolimus, anticoagulation, or antiplatelet drugs
Vascular complications in arteries used to access the coronary artery which may require blood transfusion or surgical artery repair, including: • Complications at groin or arm access site • Bleeding • Formation of an abnormal connection between an artery and a vein next to it • Leaking of blood from an artery to the surrounding tissue (usually as a result of a puncture to the artery) • Weakness in wall of artery (causing possible serious bleeding complications) • Partial/complete tear of the wall of the artery • Vessel puncture or rupture • Movement of air, tissue, plaque, thrombotic or device material downstream in the arteries resulting in blockage in blood flow • Nerve damage caused by compression of the nerves, injury to the nerve or interruption of blood supply to the nerves • Decreased blood supply to the arms and / or legs which may cause cramping or pain
Complications at the heart arteries which may require additional treatment or surgery, including: • Complete blockage of the coronary artery, which may require a repeat procedure or emergency surgery to reopen the coronary artery • Formation of an abnormal connection between a heart artery and a vein next to it, • Leaking of blood from a heart artery to the surrounding tissue (usually as a result of a puncture to the artery) • Weakness in wall of the heart artery (causing possible serious bleeding complications) • Partial or complete tear of the wall of the artery supplying the heart muscle • Puncture or rupture of the wall of the artery supplying the heart muscle • Tissue extending from an artery wall and projecting into the lumen between stent struts after implantation • Movement of air, tissue, plaque, thrombotic or device material that partially or completely blocks the heart artery and/or implanted scaffold. Development of blood clots partially or completely blocking blood flow within the artery and/or the implanted scaffold • Narrowing or Re-narrowing of the treated heart artery
Complications in the sac around the heart which may require additional treatment, including: • Rapid accumulation of blood in the sac around the heart resulting in squeezing of the heart so it cannot pump out blood to the rest of the body, which may require additional treatment or emergency surgery
An abnormal accumulation of blood around the heart. Inflammation of the tissue around the heart (causing possible chest pain)
Irregular heartbeats (originating from abnormal electrical activity in the heart, or from the upper or lower chambers of the heart)
Decreased blood and/or oxygen supply to a part of the heart muscle which may cause: • Heart attack (permanent damage of an area of the heart tissue, due to interruption in the blood flow to the heart muscle) • Chest pain (which may radiate to jaw or arm) or discomfort, temporary contraction of the heart arteries
Stroke or temporary stroke symptoms as a result of a brief episode of decreased oxygen to the brain causing blurred vision, dizziness, faintness, and numbness
Altered organ function in acutely ill patients, usually involving two or more organ systems, including: • Stoppage of heart and lung function• Heart function failure • Kidneys fail to function normally • Heart and lung function failure (potentially leading to development of fluid in the lungs and severe difficulty breathing) • Shock (inability to maintain enough blood pressure to keep enough blood delivered to your organs. Shock is a life threatening condition that may require hospitalization)
Blood cell abnormalities • Low / high blood pressure • Feeling of the heart beating rapidly, dizziness, fainting • Infection • Chest pain • Fever • Pain • Death
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