4
1.0 Introduction
1.5 Potential Complications and Risks
The HeartWare
™
HVAD
™
System has been studied in clinical trials and a variety of
potential complications were identied. Many of these complications were well
known from prior experience with other VADs. However it is important that you
understand all of the potential complications that may occur with the HeartWare
™
HVAD
™
System.
Talk to your clinician to understand your risks and potential complications if
implanted with the HeartWare
™
HVAD
™
System, especially the risk of having a stroke.
The risk of death as a result of stroke has been observed in randomized clinical trials
to be higher with the HVAD than with alternative treatment options. The overall rate
of stroke was shown to be higher with the HVAD than with alternative treatment
options; however, one of the trials suggested that closely following a blood pressure
treatment plan as recommended by your physician may reduce your stroke risk.
Please refer to Section 1.8, the Summary of Clinical Study Information, to learn more
about strokes that have occurred in patients with an HVAD
®
Pump. Complications
can occur around the time of implant as well as any time while the system is
providing support.
Implantation of any VAD is a major operation that may lead to serious complications.
Complications associated with HearWare
™
HVAD
™
System use and the percentages
of patients who develop these complications are shown in the next table. It is possi-
ble that a complication not listed in this table may occur.
WARNING! Serious and life threatening adverse events, especially stroke, have been associated
with use of this device. The risk of death as a result of stroke has been observed in randomized
clinical trials to be higher with the HVAD than with alternative treatment options. The overall rate
of stroke was shown in randomized clinical trials to be higher with the HVAD than with alternative
treatment options; however, one of the trials suggested that closely following a blood pressure
treatment plan as recommended by your physician may reduce your stroke risk. You must fully
consider and discuss with your physician the risks of this device with that of other treatment
modalities before deciding to proceed with device implantation.
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