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Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies
IDE G030052 Pivotal
15
FTW
(n=32)
Bleeding
74
27
84%
Respiratory Failure 14
14
44%
Arrhythmias
14
12
38%
Hypertension
1
1
3%
Hypotension
1
1
3%
Hepatic
1
1
3%
Dysfunction
Renal Failure/
8
8
25%
Dysfunction
Neurologic
0
0
0%
Dysfunction
Venous
2
2
6%
Thromboembolism
Pericardial Fluid
0
0
0%
Collection
Right Heart
2
2
6%
Failure
Hemolysis
4
4
13%
Myocardial
0
0
0%
Infarction
Psychiatric
2
2
6%
Episode
Arterial non-CNS
1
1
3%
Thromboembolism
Wound
1
1
3%
Dehiscence
Cardiac
0
0
0%
Tamponade
14
IDE G030052 Pilot
IDE G040029 Pilot
16
Cardiogenic Shock (BVAD)
RVAD w/ LVAD
(n=26)
(n=12)
34
20
77%
29
20
20
77%
9
14
9
35%
14
0
0
0%
0
5
5
19%
2
8
7
27%
3
3
3
12%
1
8
8
31%
2
0
0
0%
3
0
0
0%
0
14
14
54%
1
7
4
15%
1
0
0
0%
0
0
0
0%
0
0
0
0%
0
0
0
0%
0
3
3
12%
2
RVAD HDE PAS
17
RVAD w/ HMII LVAD
(n=25)
11
92%
51
20
8
67%
20
16
4
33%
17
16
0
0%
9
5
2
17%
0
0
2
17%
0
0
1
8%
12
12
2
17%
4
4
3
25%
1
1
0
0%
5
4
1
8%
7
6
1
8%
2
2
0
0%
1
1
0
0%
3
3
0
0%
1
1
0
0%
0
0
2
17%
0
0
28
All CentriMag System Clinical
Patients
18
(n=95)
80%
188
78
82%
64%
63
58
61%
64%
59
41
43%
20%
10
6
6%
0%
8
8
8%
0%
12
10
11%
48%
24
24
25%
16%
14
14
15%
4%
6
6
6%
16%
5
4
4%
24%
24
23
24%
8%
14
11
12%
4%
1
1
1%
12%
5
5
5%
4%
2
2
2%
0%
1
1
1%
0%
5
5
5%
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