Abbott CentriMag, Reference Manual, Page: 28 / 32

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Table 13. Summary of Adverse Events, All CentriMag System Clinical Studies 14
IDE G030052 Pivotal IDE G030052 Pilot IDE G040029 Pilot RVAD HDE PAS All CentriMag System Clinical
Patients
FTW 15 Cardiogenic Shock (BVAD) 16 RVAD w/ LVAD 17 RVAD w/ HMII LVAD 18
(n=32) (n=26) (n=12) (n=25) (n=95)
Limb Ischemia 0 0 0% 0 0 0% 2 2 17% 0 0 0% 2 2 2%
Aneurysm 0 0 0% 0 0 0% 1 1 8% 0 0 0% 1 1 1%
Device Failure 0 0 0% 0 0 0% 0 0 0% 0 0 0% 0 0 0%
Device
Malfunction 1 1 3% 2 2 8% 1 1 8% 0 0 0% 4 4 4%
Other 12 19 9 28% 0 0 0% 0 0 0% 21 20 10 40% 33 19 20%
19 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
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