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6.0 Potential Adverse Events
Potential risks associated with the overall procedure including access, cardiac
catheterization, local and/or general anesthesia:
• Allergic reaction to antithrombotic therapy or contrast medium or
anesthesia
• Anemia
• Aneurysm
• Angina
• Arrhythmias including ventricular fibrillation (VF) and ventricular
tachycardia (VT)
• AV fistula or pseudoaneurysm
• Cardiogenic shock
• Compartment syndrome
• Death
• Dissection: aortic or other vessels
• Emboli, distal (air, tissue or thrombotic emboli)
• Hematoma
• Hypertension or hypotension
• Inflammation
• Myocardial ischemia or infarction
• Pain or changes at the access site
• Perforation or rupture of cardiac structures
• Perforation or rupture of vessels
• Pericardial effusion or cardiac tamponade
• Peripheral ischemia or nerve injury or brachial plexus injury
• Pulmonary edema
• Renal insufficiency or renal failure
• Respiratory insufficiency or respiratory failure
• Syncope
• Thoracic bleeding
• Vasovagal response
• Vessel spasm
• Vessel thrombosis/occlusion
• Vessel trauma requiring surgical repair or intervention
Additional potential risks associated with the TAVR procedure, the
bioprosthesis, and the use of its associated devices and accessories include:
• Allergic/immunologic reaction to the implant
• Atrial fibrillation/Atrial flutter
• Bleeding requiring transfusion or intervention
• Cardiac arrest
• Cardiac failure or low cardiac output
• Cardiogenic shock
• Conduction system injury (defect) including AV block, which may require
a permanent pacemaker
• Coronary occlusion
• Dissection, rupture, trauma of the aortic annulus and surrounding
structures including ascending aorta, coronary ostia and ventricular
septum
• Emergency cardiac surgery
• Hemolysis
• Infection, fever, septicemia, abscess, endocarditis
• Injury to mitral valve
• Left ventricular outflow tract obstruction
• Mechanical failure of delivery system, and/or accessories, including
balloon rupture and tip separation
• Silent cerebral ischemia, stroke, transient ischemic attack, cognitive
impairment
• Structural valve deterioration (wear, fracture, calcification, stenosis)
• Valve deployment in unintended location
• Valve explants
• Valve migration, malposition or embolization requiring intervention
• Valve regurgitation, paravalvular or transvalvular
• Valve thrombosis
7.0 Directions for Use
7.1 System Compatibility
20 mm
System
Product
Name
Edwards
SAPIEN 3
9600TFX
Transcatheter
(20 mm)
Heart Valve
Edwards
Commander
9610TF20
Delivery
System
Sheath provided by Edwards Lifesciences
Inflation device, Qualcrimp Crimping Accessory, Crimp Stopper and
Loader provided by Edwards Lifesciences
Edwards
Crimper
*If using the eSheath introducer set, use 16F or equivalent
Additional Equipment:
• Standard cardiac catheterization lab equipment
• Fluoroscopy (fixed, mobile or semi-mobile fluoroscopy systems
appropriate for use in percutaneous coronary interventions)
• Transesophageal or transthoracic echocardiography capabilities
• Exchange length 0.035 inch (0.89 mm) extra-stiff guidewire
• Pacemaker (PM) and pacing lead
• Edwards Transfemoral Balloon catheter or equivalent
4
Table 5
23 mm
26 mm
29 mm
System
System
System
Model
9600TFX
9600TFX
9600TFX
(23 mm)
(26 mm)
(29 mm)
9610TF23
9610TF26
9610TF29*
9600CR
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