10
9
8
7
6
5
4
3
2
1
Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
PumpOverviewIntroduction
17Introduction
1.7 Pivotal US Clinical Study: Bridge-to-Transplant (continued)
Table 5: Summary of Serious Adverse Events (HeartWare
™
HVAD
™
System N=140)
Serious Adverse Events (SAEs)
Subjects
Total Serious Adverse Events 452 118 (84.3)
287 98 (70.0)
“Other” 164 75 (53.6)
UADE 1 1 (0.7)
Device Exchange
Device exchange occurred in 7 patients (7/140, 5.0%) in the SAF population during the period
180 days post-implant. Of these 7 exchanges, 3 were resultant from retained tissue being pulled
into the pump from the ventricle in the very early post-operative period and were deemed to be
procedure related, 2 were exchanged due to thrombus inside the pump, one was exchanged
for a high power event of unknown cause and one due to latent right heart failure which
caused the patient to require a biventricular support system.
Device Malfunctions
HeartWare
™
HVAD
™
System, which either directly causes or could potentially, cause or induce
a state of inadequate circulatory support (low cardiac output state) or death. There was
information on 26 malfunctions from 20 subjects entered into the clinical database during the
study period (Table 6).
Table 6: Malfunctions by Suspected Component
HeartWare
™
HVAD
™
Device Component ID
Events
Pump 7 (5.0) *
Controller 7 (5.0)
Battery 1 (0.7)
Battery Charger 0
Monitor 0
Driveline 2 (1.4)
Controller AC Adapter 6 (4.3)
Other Component 3 (2.1)
*Described in Pump Exchange section
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