HeartWare Ventricular Assist System Patient Manual page 17

machine and a breathing machine. Each of these procedures may lead to serious complications.
Complications associated with HeartWare® System use and the percentages of patients who
develop these complications are shown in the table below. It is possible that a complication not
listed in this table may occur.
WARNING! Serious and life threatening adverse events, including stroke, have been
associated with use of this device. A user must fully consider the risks of this device with
that of other treatment modalities before deciding to proceed with device implantation.
Complications That May Occur with the HeartWare® System:
Complication
Infection
Bleeding
Irregular Heart Beat
Failure of the Right Side of
the Heart
Lung Problems
HeartWare® System
Malfunction/Failure
Nervous System (brain or
nerve) Problems
Stroke
Blood Clots in the
Bloodstream
Psychological Problems
Kidney Problems
Liver Problems
HeartWare® Ventricular Assist System Patient Manual
Percent Chance for
Patients to Have
this Complication
40%
Hospitalization, blood transfusion, surgery,
39%
32%
Hospitalization, medication, pump for right
22%
18%
16% Hospitalization, medication, surgery, death
15%
12%
10%
8%
8% Hospitalization, medication, dialysis, death
5%
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Result of Having a Complication
Hospitalization, medication, death
death
Hospitalization, medication,
cardioversion*, death
side of heart, death
Hospitalization, medication, ventilator,
death
Confusion, loss of memory, pain, death
Hospitalization, medication, surgery,
rehabilitation, death
Hospitalization, medication, death
Hospitalization, medication, depression
Hospitalization, medication, death