SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 8
6.3
Adverse Events
Adverse events collected for all 81 core patients while on the SynCardia TAH-
t device are presented in descending order below. The adverse events
represent 17.6 device years of experience for an overall event rate of 1.9 events
per month while on the device awaiting transplant.
Table 1
Incidence of Adverse Events in Core Patients During
Device Implantation,
in Decreasing Order of Frequency
(Represents 17.6 years or 6411 days on the device)
Adverse Event
Number of
Events
Number (%) of
Patients
n=81
Any Adverse Event
400
76 (93.8%)
Infection 125
58
(71.6%)
Bleeding 55
34
(42.0%)
Respiratory Dysfunction
44
24 (29.6%)
Hepatic Dysfunction
30
29 (35.8%)
Neurological Event
26
20 (24.7%)
Renal Dysfunction
23
21 (25.9%)
Reoperation 18
17
(21.0%)
Device Malfunction
18
15 (18.5%)
Peripheral
Thromboembolism
14 9
(11.1%)
Reduced Blood Pressure
13
12 (14.8%)
Reduced Cardiac Index
11
7 (8.6%)
Technical/Procedural 11 3
(3.7%)
Fit Complication
5
5 (6.2%)
Hemolysis 3
3
(3.7%)
Miscellaneous 3
3
(3.7%)
