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• Bleeding
• Anemia
• Abnormal lab values (including electrolyte imbalance)
• Hypertension or hypotension
• Allergic reaction to anesthesia, contrast media, or device materials
• Hematoma
• Syncope
• Pain or changes at the access site
• Exercise intolerance or weakness
• Inflammation
• Angina
• Heart murmur
• Fever
Additional potential risks associated with the use of the valve, delivery system, and/or accessories
include:
• Cardiac arrest
• Cardiogenic shock
• Emergency cardiac surgery
• Cardiac failure or low cardiac output
• Coronary flow obstruction/transvalvular flow disturbance
• Device thrombosis requiring intervention
• Valve thrombosis
• Device embolization
• Device migration or malposition requiring intervention
• Valve deployment in unintended location
• Valve stenosis
• Structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts,
leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis)
• Device degeneration
• Paravalvular or transvalvular leak
• Valve regurgitation
• Hemolysis
• Device explants
• Nonstructural dysfunction
• Mechanical failure of delivery system, and/or accessories
• Non-emergent reoperation
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