Berlin Heart EXCOR Pediatric VAD, Manual, Page: 53 / 250

Chapter 3 Summary of Clinical Studies
In Cohort 1 there were 7 subjects (7/20=35%) who were sedated and intubated at 2
weeks with 1 sedated and awake (1/20=5%). The other 12 (12/20=60%) were awake
with some of those also ambulating and eating.
In Cohort 2, 6 subjects (6/20=30%) were still sedated and intubated at 2 weeks with 1
awake and intubated (1/20=5%) and the remaining 13 awake (13/20=65%). At 1
month post, those numbers drop to only 3 of the Cohort 1 and 4 of the Cohort 2
subjects remaining sedated and intubated.
Tab. 3-10 Support status at each follow-up visit
3.6.6.2 Primary Safety
The total time on device of the Cohort 1 subjects was 1411 days. There were 96
serious adverse events (SAEs) for this cohort yielding a rate of
0.068 events per
patient-day . The 95% Poisson confidence interval was calculated as: [0.055, 0.083].
The total time on device for Cohort 2 was 1376 days. There were 109 SAEs for this
cohort yielding a rate of
0.079 events per patient-day with the confidence interval as
[0.065, 0.096]. A summary of SAEs rates for each cohort is included in the first table
of this clinical study section.
a) Infection Serious Adverse Events
Major Infection events were reported according to the Investigational Plan definition
(which is the same as the INTERMACS definition). Any time an additional medication
was added for treating a different organism a new SAE was reported (or adjudicated
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