Trial Outcomes & Findings for ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) (NCT NCT01757665)

NCT ID: NCT01757665

Last Updated: 2025-11-17

Results Overview

The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 777 participants
• Primary outcome timeframe: 1 Year Post Implant
• Results posted on: 2025-11-17

Participant Flow

Participant milestones

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Overall Study STARTED	694	83
Overall Study Implanted With Device	689	82
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	694	83

Reasons for withdrawal

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Overall Study Still on Study - Visit Completed	240	30
Overall Study Still on Study - Visit Pending	398	40
Overall Study Still on Study - Missed Visit	14	1
Overall Study Death	25	8
Overall Study Explant	1	2
Overall Study Withdrawal by Subject	10	0
Overall Study Lost to Follow-up	1	1
Overall Study Not Implanted with Device	5	1

Baseline Characteristics

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

Baseline characteristics by cohort

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A n=694 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M n=83 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Total n=777 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 11.6 • n=202 Participants	68.9 years STANDARD_DEVIATION 9.3 • n=283 Participants	67.2 years STANDARD_DEVIATION 11.4 • n=120 Participants
Sex: Female, Male Female	196 Participants n=202 Participants	49 Participants n=283 Participants	245 Participants n=120 Participants
Sex: Female, Male Male	498 Participants n=202 Participants	34 Participants n=283 Participants	532 Participants n=120 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=202 Participants	0 Participants n=283 Participants	2 Participants n=120 Participants
Race (NIH/OMB) Asian	6 Participants n=202 Participants	2 Participants n=283 Participants	8 Participants n=120 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=202 Participants	0 Participants n=283 Participants	2 Participants n=120 Participants
Race (NIH/OMB) Black or African American	23 Participants n=202 Participants	2 Participants n=283 Participants	25 Participants n=120 Participants
Race (NIH/OMB) White	622 Participants n=202 Participants	73 Participants n=283 Participants	695 Participants n=120 Participants
Race (NIH/OMB) More than one race	2 Participants n=202 Participants	0 Participants n=283 Participants	2 Participants n=120 Participants
Race (NIH/OMB) Unknown or Not Reported	37 Participants n=202 Participants	6 Participants n=283 Participants	43 Participants n=120 Participants

PRIMARY outcome

Timeframe: 1 Year Post Implant

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately.

The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow-up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=716 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subjects With Structural Valve Deterioration	—	—	—	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Events occuring within 30 days of procedure

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Percentage of Subjects With Early Adverse Events All Cause Mortality	—	—	—	1.2 percentage of subjects	1.2 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Trial Valve Related Mortality	—	—	—	0.4 percentage of subjects	1.2 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Thromboembolism	—	—	—	2.2 percentage of subjects	2.4 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Valve Thrombosis	—	—	—	0.0 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events All Bleeding	—	—	—	0.9 percentage of subjects	1.2 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Major Bleeding	—	—	—	0.7 percentage of subjects	1.2 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Endocarditis	—	—	—	0.0 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Hemolysis	—	—	—	0.0 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events All Paravalvular Leak (OPC)	—	—	—	0.3 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Major Paravalvular Leak (OPC)	—	—	—	0.1 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Non-structural Valve Dysfunction	—	—	—	0.0 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Reoperation	—	—	—	0.1 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Subjects With Early Adverse Events Explant	—	—	—	0.0 percentage of subjects	0.0 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Events occurring >= 31 days and up through 3 years post-implant

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Percentage of Late Adverse Events Divided by Late Patient Years All Cause Mortality	—	—	—	2.2 percentage of events/late patient years	6.1 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Trial Valve Related Mortality	—	—	—	0.7 percentage of events/late patient years	0.9 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Thromboembolism	—	—	—	2.1 percentage of events/late patient years	1.7 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Valve Thrombosis	—	—	—	0.0 percentage of events/late patient years	0.0 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years All Bleeding	—	—	—	2.6 percentage of events/late patient years	8.7 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Major Bleeding	—	—	—	1.4 percentage of events/late patient years	5.2 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Endocarditis	—	—	—	0.6 percentage of events/late patient years	0.9 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Hemolysis	—	—	—	0.0 percentage of events/late patient years	0.0 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years All Paravalvular Leak (OPC)	—	—	—	0.2 percentage of events/late patient years	0.0 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Major Paravalvular Leak (OPC)	—	—	—	0.1 percentage of events/late patient years	0.0 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Non-structural Valve Dysfunction	—	—	—	0.0 percentage of events/late patient years	0.9 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Reoperation	—	—	—	0.2 percentage of events/late patient years	2.6 percentage of events/late patient years	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Explant	—	—	—	0.2 percentage of events/late patient years	1.7 percentage of events/late patient years	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Year Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Mean Gradient Measurements - 11000A 3 Months	6.8 mmHg Standard Deviation 2.6	4.7 mmHg Standard Deviation 1.3	9.1 mmHg Standard Deviation 4.0	13.8 mmHg Standard Deviation 6.1	10.7 mmHg Standard Deviation 4.2	9.4 mmHg Standard Deviation 3.8	8.7 mmHg Standard Deviation 3.4
Subject's Average Mean Gradient Measurements - 11000A 1 Year	8.2 mmHg Standard Deviation 3.5	—	10.4 mmHg Standard Deviation 4.9	17.6 mmHg Standard Deviation 7.8	12.6 mmHg Standard Deviation 4.7	10.1 mmHg Standard Deviation 3.8	9.6 mmHg Standard Deviation 5.2
Subject's Average Mean Gradient Measurements - 11000A 2 Year	8.3 mmHg Standard Deviation 3.5	—	10.1 mmHg Standard Deviation 4.3	16.1 mmHg Standard Deviation 6.4	11.2 mmHg Standard Deviation 4.0	9.9 mmHg Standard Deviation 4.4	9.2 mmHg Standard Deviation 3.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Mean Gradient Measurements - 11000M 3 Months	3.3 mmHg Standard Deviation 1.4	4.0 mmHg Standard Deviation 1.6	—	5.6 mmHg Standard Deviation 0.7	4.1 mmHg Standard Deviation 1.7	4.0 mmHg Standard Deviation 1.5	3.4 mmHg Standard Deviation 1.3
Subject's Average Mean Gradient Measurements - 11000M 1 Year	3.3 mmHg Standard Deviation 1.4	4.0 mmHg Standard Deviation 1.5	—	4.9 mmHg Standard Deviation 1.2	4.1 mmHg Standard Deviation 1.4	4.1 mmHg Standard Deviation 1.5	3.9 mmHg Standard Deviation 2.0
Subject's Average Mean Gradient Measurements - 11000M 2 Year	3.4 mmHg Standard Deviation 2.5	3.8 mmHg Standard Deviation 1.5	—	—	3.9 mmHg Standard Deviation 1.8	3.8 mmHg Standard Deviation 1.0	3.5 mmHg Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Peak Gradients Measurements Over Time - 11000A 3 Month	13.8 mmHg Standard Deviation 4.9	10.1 mmHg Standard Deviation 3.0	18.4 mmHg Standard Deviation 7.6	27.5 mmHg Standard Deviation 12.3	21.7 mmHg Standard Deviation 8.2	18.8 mmHg Standard Deviation 6.9	17.5 mmHg Standard Deviation 6.3
Subject's Average Peak Gradients Measurements Over Time - 11000A 1 Year	16.7 mmHg Standard Deviation 6.9	—	20.9 mmHg Standard Deviation 9.3	35.0 mmHg Standard Deviation 16.3	25.2 mmHg Standard Deviation 8.9	20.1 mmHg Standard Deviation 7.5	19.2 mmHg Standard Deviation 8.9
Subject's Average Peak Gradients Measurements Over Time - 11000A 2 Year	16.4 mmHg Standard Deviation 6.6	—	20.1 mmHg Standard Deviation 8.2	31.7 mmHg Standard Deviation 12.0	22.0 mmHg Standard Deviation 7.5	19.8 mmHg Standard Deviation 8.5	18.2 mmHg Standard Deviation 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Peak Gradients Measurements Over Time - 11000M 3 Months	17.4 mmHg Standard Deviation 22.1	10.5 mmHg Standard Deviation 7.1	—	12.0 mmHg Standard Deviation 1.4	9.8 mmHg Standard Deviation 4.0	10.2 mmHg Standard Deviation 4.2	9.0 mmHg Standard Deviation 2.8
Subject's Average Peak Gradients Measurements Over Time - 11000M 1 Year	9.0 mmHg Standard Deviation 4.1	10.1 mmHg Standard Deviation 3.8	—	10.6 mmHg Standard Deviation 3.0	9.9 mmHg Standard Deviation 3.2	10.4 mmHg Standard Deviation 3.7	10.2 mmHg Standard Deviation 5.5
Subject's Average Peak Gradients Measurements Over Time - 11000M 2 Year	8.3 mmHg Standard Deviation 3.4	9.4 mmHg Standard Deviation 4.0	—	—	9.5 mmHg Standard Deviation 4.7	10.5 mmHg Standard Deviation 3.4	6.6 mmHg Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Effective Orifice Area Measurements - 11000A 3 Months	2.3 Centimeters Squared Standard Deviation 0.7	2.5 Centimeters Squared Standard Deviation 0.8	1.8 Centimeters Squared Standard Deviation 0.6	1.4 Centimeters Squared Standard Deviation 0.4	1.5 Centimeters Squared Standard Deviation 0.4	1.7 Centimeters Squared Standard Deviation 0.4	1.8 Centimeters Squared Standard Deviation 0.5
Subject's Average Effective Orifice Area Measurements - 11000A 1 Year	2.2 Centimeters Squared Standard Deviation 0.6	—	1.7 Centimeters Squared Standard Deviation 0.5	1.1 Centimeters Squared Standard Deviation 0.2	1.3 Centimeters Squared Standard Deviation 0.3	1.6 Centimeters Squared Standard Deviation 0.4	1.8 Centimeters Squared Standard Deviation 0.5
Subject's Average Effective Orifice Area Measurements - 11000A 2 Year	1.8 Centimeters Squared Standard Deviation 0.5	—	1.6 Centimeters Squared Standard Deviation 0.5	1.0 Centimeters Squared Standard Deviation 0.4	1.3 Centimeters Squared Standard Deviation 0.3	1.6 Centimeters Squared Standard Deviation 0.4	1.9 Centimeters Squared Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Effective Orifice Area Measurements - 11000M 3 Months	1.8 Centimeters Squared Standard Deviation 0.4	1.5 Centimeters Squared Standard Deviation 0.5	—	1.2 Centimeters Squared Standard Deviation 0.3	1.4 Centimeters Squared Standard Deviation 0.4	1.6 Centimeters Squared Standard Deviation 0.6	1.6 Centimeters Squared Standard Deviation 0.4
Subject's Average Effective Orifice Area Measurements - 11000M 1 Year	1.5 Centimeters Squared Standard Deviation 0.7	1.4 Centimeters Squared Standard Deviation 0.5	—	1.1 Centimeters Squared Standard Deviation 0.4	1.2 Centimeters Squared Standard Deviation 0.3	1.5 Centimeters Squared Standard Deviation 0.6	1.4 Centimeters Squared Standard Deviation 0.5
Subject's Average Effective Orifice Area Measurements - 11000M 2 Year	1.2 Centimeters Squared Standard Deviation 0.3	1.4 Centimeters Squared Standard Deviation 0.4	—	—	1.3 Centimeters Squared Standard Deviation 0.5	1.4 Centimeters Squared Standard Deviation 0.4	1.6 Centimeters Squared Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A 3 Months	1.1 cm^2/m^2 Standard Deviation 0.3	1.1 cm^2/m^2 Standard Deviation 0.3	0.9 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.3	0.9 cm^2/m^2 Standard Deviation 0.3	0.9 cm^2/m^2 Standard Deviation 0.3
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A 1 Year	1.0 cm^2/m^2 Standard Deviation 0.3	—	0.8 cm^2/m^2 Standard Deviation 0.3	0.6 cm^2/m^2 Standard Deviation 0.1	0.7 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A 2 Year	0.8 cm^2/m^2 Standard Deviation 0.2	—	0.8 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.3	0.7 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M 3 Months	0.9 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.3	—	0.7 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.2
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M 1 Year	0.7 cm^2/m^2 Standard Deviation 0.3	0.7 cm^2/m^2 Standard Deviation 0.2	—	0.6 cm^2/m^2 Standard Deviation 0.2	0.7 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.3	0.7 cm^2/m^2 Standard Deviation 0.2
Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M 2 Year	0.6 cm^2/m^2 Standard Deviation 0.1	0.7 cm^2/m^2 Standard Deviation 0.3	—	—	0.8 cm^2/m^2 Standard Deviation 0.3	0.7 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Performance Index Measurements - 11000A 3 Months	0.9 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.3	0.9 cm^2/m^2 Standard Deviation 0.2	1.1 cm^2/m^2 Standard Deviation 0.3	0.9 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2
Subject's Average Performance Index Measurements - 11000A 1 Year	0.9 cm^2/m^2 Standard Deviation 0.2	—	0.8 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2
Subject's Average Performance Index Measurements - 11000A 2 Year	0.7 cm^2/m^2 Standard Deviation 0.2	—	0.8 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.3	0.8 cm^2/m^2 Standard Deviation 0.2	0.8 cm^2/m^2 Standard Deviation 0.2	0.9 cm^2/m^2 Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Performance Index Measurements - 11000M 3 Months	0.6 cm^2/m^2 Standard Deviation 0.1	0.6 cm^2/m^2 Standard Deviation 0.2	—	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.2	0.5 cm^2/m^2 Standard Deviation 0.1
Subject's Average Performance Index Measurements - 11000M 1 Year	0.5 cm^2/m^2 Standard Deviation 0.2	0.5 cm^2/m^2 Standard Deviation 0.2	—	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.2	0.5 cm^2/m^2 Standard Deviation 0.2
Subject's Average Performance Index Measurements - 11000M 2 Year	0.4 cm^2/m^2 Standard Deviation 0.1	0.6 cm^2/m^2 Standard Deviation 0.2	—	—	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.2	0.6 cm^2/m^2 Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Cardiac Output Over Time - 11000A 3 Months	5.2 Liters/minute Standard Deviation 1.8	4.4 Liters/minute Standard Deviation 1.2	4.8 Liters/minute Standard Deviation 1.4	5.1 Liters/minute Standard Deviation 1.3	4.5 Liters/minute Standard Deviation 1.2	4.7 Liters/minute Standard Deviation 1.4	4.8 Liters/minute Standard Deviation 1.2
Subject's Average Cardiac Output Over Time - 11000A 1 Year	5.4 Liters/minute Standard Deviation 1.6	—	4.7 Liters/minute Standard Deviation 1.6	4.5 Liters/minute Standard Deviation 0.9	4.7 Liters/minute Standard Deviation 1.8	4.4 Liters/minute Standard Deviation 1.2	4.8 Liters/minute Standard Deviation 1.7
Subject's Average Cardiac Output Over Time - 11000A 2 Year	4.4 Liters/minute Standard Deviation 1.4	—	4.5 Liters/minute Standard Deviation 1.4	3.7 Liters/minute Standard Deviation 1.1	4.3 Liters/minute Standard Deviation 1.1	4.4 Liters/minute Standard Deviation 1.2	4.9 Liters/minute Standard Deviation 1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Cardiac Output Over Time - 11000M 3 Months	4.6 Liters/Minute Standard Deviation 1.0	4.0 Liters/Minute Standard Deviation 1.1	—	4.0 Liters/Minute Standard Deviation 1.2	3.6 Liters/Minute Standard Deviation 0.9	4.3 Liters/Minute Standard Deviation 1.4	3.9 Liters/Minute Standard Deviation 0.8
Subject's Average Cardiac Output Over Time - 11000M 1 Year	3.8 Liters/Minute Standard Deviation 0.8	3.8 Liters/Minute Standard Deviation 1.4	—	3.7 Liters/Minute Standard Deviation 1.0	3.3 Liters/Minute Standard Deviation 1.1	4.4 Liters/Minute Standard Deviation 1.9	3.8 Liters/Minute Standard Deviation 1.1
Subject's Average Cardiac Output Over Time - 11000M 2 Year	3.3 Liters/Minute Standard Deviation 0.6	3.6 Liters/Minute Standard Deviation 1.1	—	—	3.3 Liters/Minute Standard Deviation 1.1	4.1 Liters/Minute Standard Deviation 1.3	3.6 Liters/Minute Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Cardiac Index Over Time- 11000A 3 Months	2.4 L/min/m^2 Standard Deviation 0.9	2.0 L/min/m^2 Standard Deviation 0.4	2.4 L/min/m^2 Standard Deviation 0.7	3.0 L/min/m^2 Standard Deviation 0.8	2.4 L/min/m^2 Standard Deviation 0.7	2.4 L/min/m^2 Standard Deviation 0.8	2.3 L/min/m^2 Standard Deviation 0.6
Subject's Average Cardiac Index Over Time- 11000A 1 Year	2.4 L/min/m^2 Standard Deviation 0.7	—	2.3 L/min/m^2 Standard Deviation 0.8	2.6 L/min/m^2 Standard Deviation 0.5	2.5 L/min/m^2 Standard Deviation 1.0	2.2 L/min/m^2 Standard Deviation 0.6	2.2 L/min/m^2 Standard Deviation 0.8
Subject's Average Cardiac Index Over Time- 11000A 2 Year	2.0 L/min/m^2 Standard Deviation 0.6	—	2.2 L/min/m^2 Standard Deviation 0.7	2.2 L/min/m^2 Standard Deviation 0.8	2.3 L/min/m^2 Standard Deviation 0.6	2.2 L/min/m^2 Standard Deviation 0.7	2.3 L/min/m^2 Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Cardiac Index Over Time - 11000M 3 Months	2.1 L/min/m^2 Standard Deviation 0.8	2.1 L/min/m^2 Standard Deviation 0.6	—	2.2 L/min/m^2 Standard Deviation 0.7	2.1 L/min/m^2 Standard Deviation 0.6	2.2 L/min/m^2 Standard Deviation 0.6	1.9 L/min/m^2 Standard Deviation 0.4
Subject's Average Cardiac Index Over Time - 11000M 1 Year	1.8 L/min/m^2 Standard Deviation 0.4	2.0 L/min/m^2 Standard Deviation 0.7	—	2.0 L/min/m^2 Standard Deviation 0.5	1.9 L/min/m^2 Standard Deviation 0.5	2.2 L/min/m^2 Standard Deviation 0.9	1.9 L/min/m^2 Standard Deviation 0.5
Subject's Average Cardiac Index Over Time - 11000M 2 Year	1.6 L/min/m^2 Standard Deviation 0.3	1.9 L/min/m^2 Standard Deviation 0.6	—	—	1.9 L/min/m^2 Standard Deviation 0.7	2.1 L/min/m^2 Standard Deviation 0.5	1.9 L/min/m^2 Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 3 Months · 0 None	69 Participants	11 Participants	531 Participants	17 Participants	106 Participants	166 Participants	162 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 1 Year · +3 Moderate	0 Participants	—	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 3 Months · +1 Trivial/Trace	20 Participants	1 Participants	80 Participants	3 Participants	11 Participants	25 Participants	20 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 1 Year · +4 Severe	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 3 Months · +2 Mild	1 Participants	0 Participants	10 Participants	1 Participants	1 Participants	3 Participants	4 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 3 Months · +3 Moderate	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 3 Months · +4 Severe	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 1 Year · 0 None	49 Participants	—	385 Participants	11 Participants	88 Participants	125 Participants	112 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 1 Year · +1 Trivial/Trace	17 Participants	—	64 Participants	3 Participants	6 Participants	26 Participants	12 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 1 Year · +2 Mild	2 Participants	—	21 Participants	2 Participants	2 Participants	8 Participants	7 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 2 Year · 0 None	11 Participants	—	136 Participants	4 Participants	32 Participants	51 Participants	38 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 2 Year · +1 Trivial/Trace	5 Participants	—	32 Participants	2 Participants	5 Participants	11 Participants	9 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 2 Year · +2 Mild	2 Participants	—	14 Participants	2 Participants	5 Participants	3 Participants	2 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 2 Year · +3 Moderate	0 Participants	—	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000A 2 Year · +4 Severe	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 3 Months · 0 None	4 Participants	51 Participants	—	4 Participants	15 Participants	18 Participants	10 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 3 Months · +1 Trivial/Trace	2 Participants	18 Participants	—	1 Participants	7 Participants	5 Participants	3 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 3 Months · +2 Mild	0 Participants	5 Participants	—	0 Participants	3 Participants	0 Participants	2 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 3 Months · +3 Moderate	0 Participants	1 Participants	—	0 Participants	1 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 3 Months · +4 Severe	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 1 Year · 0 None	3 Participants	42 Participants	—	3 Participants	15 Participants	13 Participants	8 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 1 Year · +1 Trivial/Trace	2 Participants	19 Participants	—	1 Participants	5 Participants	7 Participants	4 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 1 Year · +2 Mild	1 Participants	5 Participants	—	0 Participants	4 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 1 Year · +3 Moderate	0 Participants	2 Participants	—	0 Participants	1 Participants	1 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 1 Year · +4 Severe	0 Participants	1 Participants	—	0 Participants	0 Participants	0 Participants	1 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 2 Year · 0 None	0 Participants	13 Participants	—	—	6 Participants	6 Participants	1 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 2 Year · +1 Trivial/Trace	2 Participants	6 Participants	—	—	2 Participants	1 Participants	1 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 2 Year · +2 Mild	0 Participants	4 Participants	—	—	4 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 2 Year · +3 Moderate	0 Participants	1 Participants	—	—	1 Participants	0 Participants	0 Participants
Subject's Amount of Total Valvular Regurgitation Over Time - 11000M 2 Year · +4 Severe	0 Participants	0 Participants	—	—	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=100 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=20 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total n=689 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=22 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=131 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=214 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=202 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Amount of Paravalvular Leak Over Time - 11000A 3 Months · 0 None	87 Participants	12 Participants	610 Participants	20 Participants	118 Participants	191 Participants	182 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 3 Months · +1 Trivial/Trace	2 Participants	0 Participants	7 Participants	1 Participants	0 Participants	3 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 3 Months · +2 Mild	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 3 Months · +3 Moderate	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 3 Months · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 1 Year · 0 None	67 Participants	—	450 Participants	12 Participants	92 Participants	152 Participants	127 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 1 Year · +1 Trivial/Trace	0 Participants	—	8 Participants	2 Participants	1 Participants	3 Participants	2 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 1 Year · +2 Mild	2 Participants	—	10 Participants	1 Participants	3 Participants	3 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 1 Year · +3 Moderate	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 1 Year · +4 Severe	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 2 Year · 0 None	16 Participants	—	166 Participants	6 Participants	37 Participants	61 Participants	46 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 2 Year · +1 Trivial/Trace	2 Participants	—	6 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 2 Year · +2 Mild	0 Participants	—	9 Participants	2 Participants	4 Participants	2 Participants	1 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 2 Year · +3 Moderate	0 Participants	—	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000A 2 Year · +4 Severe	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000M device where data is available.

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm n=6 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm n=82 Participants The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=6 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=29 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm n=25 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm n=16 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Amount of Paravalvular Leak Over Time - 11000M 3 Months · 0 None	6 Participants	75 Participants	—	5 Participants	26 Participants	23 Participants	15 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 3 Months · +1 Trivial/Trace	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 3 Months · +2 Mild	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 3 Months · +3 Moderate	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 3 Months · +4 Severe	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 1 Year · 0 None	6 Participants	67 Participants	—	4 Participants	25 Participants	21 Participants	11 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 1 Year · +1 Trivial/Trace	0 Participants	2 Participants	—	0 Participants	0 Participants	0 Participants	2 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 1 Year · +2 Mild	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 1 Year · +3 Moderate	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 1 Year · +4 Severe	0 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 2 Year · 0 None	2 Participants	24 Participants	—	—	13 Participants	7 Participants	2 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 2 Year · +1 Trivial/Trace	0 Participants	0 Participants	—	—	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 2 Year · +2 Mild	0 Participants	0 Participants	—	—	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 2 Year · +3 Moderate	0 Participants	0 Participants	—	—	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time - 11000M 2 Year · +4 Severe	0 Participants	0 Participants	—	—	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months, 1 Year, and 2 Years Post Implant

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Improved	—	—	—	431 Participants	66 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Same	—	—	—	200 Participants	7 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Worsened	—	—	—	14 Participants	2 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Improved	—	—	—	331 Participants	66 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Same	—	—	—	161 Participants	7 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Worsened	—	—	—	17 Participants	0 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Improved	—	—	—	157 Participants	26 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Same	—	—	—	75 Participants	3 Participants	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Worsened	—	—	—	8 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and one year post-implant

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Physical Health-Baseline	—	—	—	42.9 units on a scale Standard Deviation 9.7	40.1 units on a scale Standard Deviation 8.9	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Physical Health-1 Year	—	—	—	49.1 units on a scale Standard Deviation 9.2	48.8 units on a scale Standard Deviation 7.0	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Mental Health-Baseline	—	—	—	50.9 units on a scale Standard Deviation 9.5	49.2 units on a scale Standard Deviation 11.5	—	—
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey Mental Health-1 Year	—	—	—	53.8 units on a scale Standard Deviation 8.5	52.3 units on a scale Standard Deviation 9.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average White Blood Cell Count 1 Year	—	—	—	7.3 10^3 cells /microliter Standard Deviation 1.9	7.1 10^3 cells /microliter Standard Deviation 2.3	—	—
Subject's Average White Blood Cell Count 2 Year	—	—	—	7.3 10^3 cells /microliter Standard Deviation 1.8	7.4 10^3 cells /microliter Standard Deviation 1.8	—	—
Subject's Average White Blood Cell Count Baseline	—	—	—	7.2 10^3 cells /microliter Standard Deviation 1.9	7.4 10^3 cells /microliter Standard Deviation 2.6	—	—
Subject's Average White Blood Cell Count Discharge	—	—	—	9.1 10^3 cells /microliter Standard Deviation 2.8	10.4 10^3 cells /microliter Standard Deviation 5.3	—	—
Subject's Average White Blood Cell Count 3 Months	—	—	—	7.1 10^3 cells /microliter Standard Deviation 1.7	7.1 10^3 cells /microliter Standard Deviation 2.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.

Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Red Blood Cells Count 1 Year	—	—	—	4.7 10^6 cells/microliters Standard Deviation 0.5	4.5 10^6 cells/microliters Standard Deviation 0.6	—	—
Subject's Average Red Blood Cells Count 2 Year	—	—	—	4.6 10^6 cells/microliters Standard Deviation 0.5	4.6 10^6 cells/microliters Standard Deviation 0.5	—	—
Subject's Average Red Blood Cells Count Baseline	—	—	—	4.5 10^6 cells/microliters Standard Deviation 0.5	4.4 10^6 cells/microliters Standard Deviation 0.6	—	—
Subject's Average Red Blood Cells Count Discharge	—	—	—	3.3 10^6 cells/microliters Standard Deviation 0.5	3.3 10^6 cells/microliters Standard Deviation 0.4	—	—
Subject's Average Red Blood Cells Count 3 Months	—	—	—	4.7 10^6 cells/microliters Standard Deviation 0.5	4.5 10^6 cells/microliters Standard Deviation 0.7	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Hematocrit Percentage Baseline	—	—	—	41.0 percentage of red blood cells Standard Deviation 4.0	40.3 percentage of red blood cells Standard Deviation 4.6	—	—
Subject's Average Hematocrit Percentage Discharge	—	—	—	30.1 percentage of red blood cells Standard Deviation 4.1	30.1 percentage of red blood cells Standard Deviation 3.9	—	—
Subject's Average Hematocrit Percentage 3 Months	—	—	—	41.0 percentage of red blood cells Standard Deviation 4.2	39.3 percentage of red blood cells Standard Deviation 5.3	—	—
Subject's Average Hematocrit Percentage 1 Year	—	—	—	41.9 percentage of red blood cells Standard Deviation 4.1	41.3 percentage of red blood cells Standard Deviation 4.8	—	—
Subject's Average Hematocrit Percentage 2 Year	—	—	—	42.0 percentage of red blood cells Standard Deviation 3.9	42.4 percentage of red blood cells Standard Deviation 4.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Hemoglobin Count Baseline	—	—	—	13.8 g/dl Standard Deviation 1.5	13.3 g/dl Standard Deviation 1.6	—	—
Subject's Average Hemoglobin Count Discharge	—	—	—	10.0 g/dl Standard Deviation 1.4	9.9 g/dl Standard Deviation 1.2	—	—
Subject's Average Hemoglobin Count 3 Months	—	—	—	13.5 g/dl Standard Deviation 1.6	12.7 g/dl Standard Deviation 1.9	—	—
Subject's Average Hemoglobin Count 1 Year	—	—	—	14.0 g/dl Standard Deviation 1.7	13.6 g/dl Standard Deviation 1.6	—	—
Subject's Average Hemoglobin Count 2 Year	—	—	—	14.0 g/dl Standard Deviation 1.5	14.0 g/dl Standard Deviation 1.3	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year, and 2 Years

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Platelet Count Discharge	—	—	—	217.7 10^3 platelets per microliter Standard Deviation 90.1	196.0 10^3 platelets per microliter Standard Deviation 75.3	—	—
Subject's Average Platelet Count Baseline	—	—	—	208.6 10^3 platelets per microliter Standard Deviation 59.0	203.6 10^3 platelets per microliter Standard Deviation 52.1	—	—
Subject's Average Platelet Count 3 Months	—	—	—	215.3 10^3 platelets per microliter Standard Deviation 62.6	221.0 10^3 platelets per microliter Standard Deviation 71.8	—	—
Subject's Average Platelet Count 1 Year	—	—	—	207.7 10^3 platelets per microliter Standard Deviation 65.8	207.8 10^3 platelets per microliter Standard Deviation 51.7	—	—
Subject's Average Platelet Count 2 Year	—	—	—	200.6 10^3 platelets per microliter Standard Deviation 54.5	204.0 10^3 platelets per microliter Standard Deviation 54.1	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Plasma Free Hemoglobin Baseline	—	—	—	11.6 mg/dl Standard Deviation 18.4	19.8 mg/dl Standard Deviation 32.5	—	—
Subject's Average Plasma Free Hemoglobin Discharge	—	—	—	7.3 mg/dl Standard Deviation 12.2	7.2 mg/dl Standard Deviation 6.5	—	—
Subject's Average Plasma Free Hemoglobin 3 Months	—	—	—	12.4 mg/dl Standard Deviation 22.2	10.6 mg/dl Standard Deviation 12.1	—	—
Subject's Average Plasma Free Hemoglobin 1 Year	—	—	—	13.8 mg/dl Standard Deviation 25.5	8.6 mg/dl Standard Deviation 12.3	—	—
Subject's Average Plasma Free Hemoglobin 2 Year	—	—	—	17.3 mg/dl Standard Deviation 33.9	20.5 mg/dl Standard Deviation 33.9	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average International Normalized Ratio Baseline	—	—	—	1.1 Ratio Standard Deviation 0.2	1.4 Ratio Standard Deviation 0.7	—	—
Subject's Average International Normalized Ratio Discharge	—	—	—	1.3 Ratio Standard Deviation 0.4	1.7 Ratio Standard Deviation 0.6	—	—
Subject's Average International Normalized Ratio 3 Months	—	—	—	1.3 Ratio Standard Deviation 0.7	1.9 Ratio Standard Deviation 0.8	—	—
Subject's Average International Normalized Ratio 1 Year	—	—	—	1.2 Ratio Standard Deviation 0.5	1.7 Ratio Standard Deviation 0.8	—	—
Subject's Average International Normalized Ratio 2 Year	—	—	—	1.2 Ratio Standard Deviation 0.6	1.6 Ratio Standard Deviation 0.8	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year and 2 Year

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Partial Thromboplastin Time Discharge	—	—	—	32.1 Seconds Standard Deviation 8.5	37.2 Seconds Standard Deviation 14.5	—	—
Subject's Average Partial Thromboplastin Time Baseline	—	—	—	30.0 Seconds Standard Deviation 6.0	35.1 Seconds Standard Deviation 14.4	—	—
Subject's Average Partial Thromboplastin Time 3 Months	—	—	—	31.2 Seconds Standard Deviation 15.8	36.0 Seconds Standard Deviation 8.1	—	—
Subject's Average Partial Thromboplastin Time 1 Year	—	—	—	29.4 Seconds Standard Deviation 5.7	35.3 Seconds Standard Deviation 14.3	—	—
Subject's Average Partial Thromboplastin Time 2 Year	—	—	—	31.4 Seconds Standard Deviation 14.4	33.7 Seconds Standard Deviation 9.5	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year, and 2 Years

Population: The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.

Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm n=82 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subject's Average Prothrombin Time Baseline	—	—	—	12.7 Seconds Standard Deviation 2.5	16.2 Seconds Standard Deviation 8.0	—	—
Subject's Average Prothrombin Time Discharge	—	—	—	15.0 Seconds Standard Deviation 5.0	20.1 Seconds Standard Deviation 7.3	—	—
Subject's Average Prothrombin Time 3 Months	—	—	—	15.2 Seconds Standard Deviation 7.4	21.0 Seconds Standard Deviation 8.4	—	—
Subject's Average Prothrombin Time 1 Year	—	—	—	13.8 Seconds Standard Deviation 5.7	19.1 Seconds Standard Deviation 8.8	—	—
Subject's Average Prothrombin Time 2 Year	—	—	—	14.1 Seconds Standard Deviation 6.4	17.3 Seconds Standard Deviation 7.9	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)

Population: The outcome is reported for subjects who received the Model 11000A device where data is available.

Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 27mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - 29mm The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Aortic Bioprosthesis, Model 11000A - Total The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 25mm n=689 Participants The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 27mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 29mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M - 31mm The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Subjects Average Serum Glycerol Levels Pre-Implant	—	—	—	405.4 micromol/L Standard Deviation 270.2	—	—	—
Subjects Average Serum Glycerol Levels Post-Implant	—	—	—	245.6 micromol/L Standard Deviation 345.8	—	—	—

Adverse Events

Edwards Pericardial Aortic Bioprosthesis, Model 11000A

Serious events: 317 serious events

Other events: 542 other events

Deaths: 26 deaths

Edwards Pericardial Mitral Bioprosthesis, Model 11000M

Serious events: 58 serious events

Other events: 66 other events

Deaths: 8 deaths

Serious adverse events

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A n=589 participants at risk；n=689 participants at risk The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M n=82 participants at risk The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
Cardiac disorders Arrhythmia - Bundle branch block - Left	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Bleeding related - Major	1.7% 12/689 • Number of events 12 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	1.6% 11/689 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Non-bleeding related	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Angina, stable	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Angina, unstable	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Atrial flutter	1.0% 7/689 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 1st degree	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 2nd degree	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 3rd degree	3.5% 24/689 • Number of events 24 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	7.3% 6/82 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Bradycardia	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Bundle branch block - Right	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Other	1.5% 10/689 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	5.7% 39/689 • Number of events 41 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	9.8% 8/82 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Permanent atrial fibrillation	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Persistent atrial fibrillation	2.0% 14/689 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	7.3% 6/82 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Supraventricular Tachycardia (SVT)	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Tachy-bradycardia	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Tachycardia - Ventricular	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Ventricular fibrillation	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Biliary (gallbladder)	0.73% 5/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Major	3.0% 21/689 • Number of events 21 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Minor	0.73% 5/689 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Gastrointestinal lower - Major	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Gastrointestinal lower - Minor	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Gastrointestinal upper - Major	0.58% 4/689 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Genitourinary - Minor	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Musculoskeletal/Dermatological - Major (e.g. ecchymosis)	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Neurological - Minor (e.g. CVA)	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax)	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Blood sepsis	1.3% 9/689 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Blood/Lymphatic - Other	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Bone fracture/Break	1.2% 8/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Cancer - Newly diagnosed	1.3% 9/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Cancer - Progression of underlying disease	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiac arrest	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiac decompensation	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiogenic shock	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiovascular - Other	3.3% 23/689 • Number of events 24 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	7.3% 6/82 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Coronary artery ostial obstruction	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Endocarditis	1.0% 7/689 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Endocrine complications	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Fever - Unknown origin	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Gastrointestinal - Esophageal rupture/tear	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Gastrointestinal - Infection	1.0% 7/689 • Number of events 8 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Gastrointestinal - Other	2.9% 20/689 • Number of events 25 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Genitourinary - Other	1.3% 9/689 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Heart failure - Acute	1.0% 7/689 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Heart Failure - Chronic (CHF)	1.6% 11/689 • Number of events 13 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Hepatic complication - Other	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Hypertension - Systemic	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Hypotension	1.2% 8/689 • Number of events 8 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Hypoxemia	0.73% 5/689 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Infection/Inflammation - Other	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Metabolic complications	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Muscular skeletal/Dermatologic - Other	3.9% 27/689 • Number of events 31 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Myocardial infarction	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Nonspecific, unknown, or other body system - Other complication	6.2% 43/689 • Number of events 51 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +2 Minor	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +3 Major	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +4 Major	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Pancreatic complication	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericardial effusion - Major	1.2% 8/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericardial effusion - Minor	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericardial tamponade	1.5% 10/689 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericarditis	0.73% 5/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Bilateral	1.9% 13/689 • Number of events 13 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Left	1.0% 7/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Right	2.2% 15/689 • Number of events 15 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 14/689 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Psychiatric disorders Psychiatric - Other	1.0% 7/689 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Psychiatric disorders Psychiatric disorder	0.15% 1/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism - Bilateral	0.87% 6/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory - Other	1.2% 8/689 • Number of events 8 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Tricuspid-indeterminate +4	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal dysfunction	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal - Other	0.73% 5/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal failure - Acute	1.2% 8/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal failure - Chronic	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory dysfunction/Insufficiency	1.2% 8/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)	0.73% 5/689 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - COPD	0.73% 5/689 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Hemothorax	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Other	1.5% 10/689 • Number of events 12 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Pneumonia	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Pneumothorax	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory infection - Pneumonia	1.0% 7/689 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory infection - Upper (URI)	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Speech disorder	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Splenic complication	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Sternal wound/Thoracic infection	1.9% 13/689 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders SVD - Study valve leaflet tear	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Thrombocytopenia - Heparin Induced (HIT)	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Thrombocytopenia - Non-heparin induced	0.29% 2/689 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Other - Central - No paresis	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Other - Peripheral - No paresis	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Stroke	2.2% 15/689 • Number of events 17 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Transient Ischemic Attack (TIA)	1.0% 7/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Urinary Tract Infection (UTI)	0.58% 4/689 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Valve thrombosis - Aortic	0.00% 0/689 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Vascular disorders Vascular - Deep Vein Thrombosis (DVT)	0.44% 3/689 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Vascular disorders Vascular - Other	1.0% 7/689 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Vision disorder	0.15% 1/689 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Wound infection - Other	0.73% 5/689 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.

Other adverse events

Measure	Edwards Pericardial Aortic Bioprosthesis, Model 11000A n=589 participants at risk；n=689 participants at risk The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for patients who require replacement of their native or prosthetic aortic valve.	Edwards Pericardial Mitral Bioprosthesis, Model 11000M n=82 participants at risk The Edwards Pericardial Mitral Bioprosthesis, Model 11000M, is indicated for patients who require replacement of their native or prosthetic mitral valve.
General disorders Allergic reaction - Medication related	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Allergic reaction - Other	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Bleeding related - Major	1.9% 11/589 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	14.8% 87/589 • Number of events 87 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	22.0% 18/82 • Number of events 18 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Anemia - Non-bleeding related	10.4% 61/589 • Number of events 61 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	17.1% 14/82 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Angina, stable	0.85% 5/589 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Angina, unstable	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Atrial flutter	1.7% 10/589 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 1st degree	6.6% 39/589 • Number of events 40 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	13.4% 11/82 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 2nd degree	1.2% 7/589 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - AV block - 3rd degree	1.2% 7/589 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Bradycardia	2.9% 17/589 • Number of events 19 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Bundle branch block - Left	4.2% 25/589 • Number of events 25 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Bundle branch block - Right	4.8% 28/589 • Number of events 30 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Other	8.5% 50/589 • Number of events 50 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	9.8% 8/82 • Number of events 8 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Pacemaker/ICD malfunction	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	23.1% 136/589 • Number of events 137 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	14.6% 12/82 • Number of events 12 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Permanent atrial fibrillation	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Persistent atrial fibrillation	3.9% 23/589 • Number of events 23 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Supraventricular Tachycardia (SVT)	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Tachy-bradycardia	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Tachycardia - Non-ventricular	3.4% 20/589 • Number of events 21 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Arrhythmia - Tachycardia - Ventricular	2.7% 16/589 • Number of events 16 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Atelectasis	20.7% 122/589 • Number of events 122 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	12.2% 10/82 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Biliary (gallbladder)	0.34% 2/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Major	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Minor	1.7% 10/589 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Gastrointestinal lower - Minor	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Gastrointestinal upper - Minor	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Genitourinary - Major	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Genitourinary - Minor	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Musculoskeletal/Dermatological - Minor (e.g. ecchymosis)	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Neurological - Major (e.g. CVA)	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Bleeding - Pulmonary/Respiratory - Minor (e.g. hemothorax)	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Blood sepsis	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Blood/Lymphatic - Other	23.4% 138/589 • Number of events 159 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	17.1% 14/82 • Number of events 20 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Bone fracture/Break	0.85% 5/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Cancer - Progression of underlying disease	0.51% 3/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiogenic shock	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Cardiovascular - Other	14.4% 85/589 • Number of events 95 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	15.9% 13/82 • Number of events 16 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Endocrine complications	1.0% 6/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	11.0% 9/82 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Fever - Unknown origin	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Gastrointestinal - Infection	1.2% 7/589 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Gastrointestinal - Other	4.9% 29/589 • Number of events 31 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	11.0% 9/82 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Genitourinary - Other	3.7% 22/589 • Number of events 24 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Hearing disorder	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Heart failure - Acute	11.0% 65/589 • Number of events 65 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Heart Failure - Chronic (CHF)	2.5% 15/589 • Number of events 15 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Hepatic complication - Other	0.51% 3/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Hypertension - Pulmonary	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Hypertension - Systemic	2.9% 17/589 • Number of events 17 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Hypotension	6.5% 38/589 • Number of events 40 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	17.1% 14/82 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Hypoxemia	0.85% 5/589 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Infection/Inflammation - Other	1.9% 11/589 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Liver Failure - Chronic	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Metabolic complications	1.5% 9/589 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Muscular skeletal/Dermatologic - Other	14.8% 87/589 • Number of events 103 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	12.2% 10/82 • Number of events 12 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Nonspecific, unknown, or other body system - Other complication	18.3% 108/589 • Number of events 133 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	17.1% 14/82 • Number of events 21 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +1 Minor	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +2 Minor	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders NSD - Paravalvular leak +3 Major	0.51% 3/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Gastrointestinal disorders Pancreatic complication	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Perforation - Other	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericardial effusion - Minor	3.6% 21/589 • Number of events 21 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pericarditis	1.0% 6/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Bilateral	2.2% 13/589 • Number of events 13 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	8.5% 7/82 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Left	1.7% 10/589 • Number of events 10 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	8.5% 7/82 • Number of events 7 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Pleural effusion - Right	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 31/589 • Number of events 31 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Psychiatric disorders Psychiatric - Other	7.5% 44/589 • Number of events 46 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	7.3% 6/82 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Psychiatric disorders Psychiatric disorder	1.0% 6/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	4.4% 26/589 • Number of events 26 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism - Left	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism - Right	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory - Other	5.3% 31/589 • Number of events 32 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	6.1% 5/82 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Aortic-central/Transvalvular +3	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-central/Transvalvular +1	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-central/Transvalvular +2	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-central/Transvalvular +3	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-central/Transvalvular +4	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-indeterminate +2	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Mitral-indeterminate +3	0.51% 3/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Tricuspid-indeterminate +3	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Regurgitation - Tricuspid-indeterminate +4	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal - Other	3.1% 18/589 • Number of events 18 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal dysfunction	1.7% 10/589 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal failure - Acute	3.2% 19/589 • Number of events 19 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	4.9% 4/82 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Renal failure - Chronic	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory dysfunction/Insufficiency	3.6% 21/589 • Number of events 21 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Acute Respiratory Distress Syndrome (ARDS)	0.00% 0/589 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Asthma	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - COPD	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Other	2.2% 13/589 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Pneumonia	0.85% 5/589 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory failure - Pneumothorax	0.85% 5/589 • Number of events 5 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory infection - Pneumonia	1.0% 6/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Respiratory, thoracic and mediastinal disorders Respiratory infection - Upper (URI)	1.9% 11/589 • Number of events 11 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Speech disorder	0.17% 1/589 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Sternal wound/Thoracic infection	1.5% 9/589 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Thrombocytopenia - Heparin Induced (HIT)	0.51% 3/589 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	2.4% 2/82 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Blood and lymphatic system disorders Thrombocytopenia - Non-heparin induced	22.8% 134/589 • Number of events 134 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	22.0% 18/82 • Number of events 18 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Stroke	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Cardiac disorders Thromboembolic event - Transient Ischemic Attack (TIA)	1.0% 6/589 • Number of events 6 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Psychiatric disorders Transient psychotic syndrome	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Renal and urinary disorders Urinary Tract Infection (UTI)	4.4% 26/589 • Number of events 26 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	7.3% 6/82 • Number of events 9 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Vascular disorders Vascular - Access site complication	0.34% 2/589 • Number of events 2 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	0.00% 0/82 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Vascular disorders Vascular - Deep Vein Thrombosis (DVT)	0.68% 4/589 • Number of events 4 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Vascular disorders Vascular - Other	3.2% 19/589 • Number of events 19 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
General disorders Vision disorder	2.0% 12/589 • Number of events 14 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	3.7% 3/82 • Number of events 3 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.
Musculoskeletal and connective tissue disorders Wound infection - Other	1.4% 8/589 • Number of events 8 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.	1.2% 1/82 • Number of events 1 • Events occurring from baseline through three years post implant for the 11000A, and four years post implant for 11000M. Adverse event table is reported for Subjects who received the Model 11000A or 11000M Device.

Additional Information

Aya Westbrook, PhD, Director of Clinical Program Management

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: aya_westbrook@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
• Publication restrictions are in place

Restriction type: OTHER