Repair or replacement of mitral valve

LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.

LVEF as determined by the core echo laboratory.

LVEF as determined by the core echo laboratory.

LVEF as determined by the core echo laboratory.

LVEF as determined by the core echo laboratory.

LVEF as determined by the core echo laboratory.

Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.

Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.

Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.

Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.

Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years

Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.

Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

Cardiac output as measured by core lab echocardiography.

Cardiac output as measured by core lab echocardiography.

Cardiac output as measured by core lab echocardiography.

Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.

Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.

Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.

Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

Regurgitant volume as determined by the core echo laboratory.

Regurgitant volume as determined by the core echo laboratory.

RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

Defined as the rate of successful implantation of MitraClip(s).

Defined as successful MitraClip implantation with resulting MR of 2+ or less.

Defined as successful mitral valve repair or replacement surgery.

Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.

Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.

Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.

Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arteriovenous (AV) fistula;
• Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
• Vascular Surgical Repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arteriovenous (AV) fistula;
• Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 hours;
• Vascular Surgical Repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.

Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.

Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.

Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.

Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.

Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:

Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.

Minor: Does not require intervention.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:

Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.

Minor: Does not require intervention.

Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Mitral valve area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).

Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.

Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.

Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.

Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.

Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

"Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.