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