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Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies
IDE G030052 Pivotal
15
FTW
(n=32)
Limb Ischemia
0
0
Aneurysm
0
0
Device Failure
0
0
Device
1
1
Malfunction
Other
12
19
9
Right arm compartment syndrome, bronchorrhea and desaturation, cardiogenic shock with suspected platelet dysfunction, tear in ventricular tissue near durable LVAD sewing ring, bilateral lower extremity ischemia with gangrene, coagulopathy, pressure ulcer, right abdominal
19
wall hematoma, critical illness myopathy, septic shock, pleural effusion (x2)
20
Pressure ulcer; ischemic bowel, mediastinal washout/wound management (x7), device thrombosis, thrombus in tubing RVAD circuit (x2), thrombocytopenia (x2), microcytic hypochromic anemia (x2), thrombus on pump impellar, leukocytosis, pleural effusion, pneumothorax,
thrombus
14
IDE G030052 Pilot
16
Cardiogenic Shock (BVAD)
(n=26)
0%
0
0
0%
0%
0
0
0%
0%
0
0
0%
3%
2
2
8%
28%
0
0
0%
IDE G040029 Pilot
RVAD HDE PAS
17
RVAD w/ LVAD
RVAD w/ HMII LVAD
(n=12)
(n=25)
2
2
17%
0
1
1
8%
0
0
0
0%
0
1
1
8%
0
0
0
0%
21
20
29
All CentriMag System Clinical
Patients
18
(n=95)
0
0%
2
2
0
0%
1
1
0
0%
0
0
0
0%
4
4
10
40%
33
19
2%
1%
0%
4%
20%
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