CentriMag Blood Pump IFU (RVAS HDE)
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© 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
SUPPLIED STERILE AND READY FOR USE – DO
NOT USE IF PACKAGING IS DAMAGED OR ANY
STERILE SEALS ARE BROKEN.
WARNING (Definition)
Warnings are used if there is a potential for a
serious hazard with misuse of the device, when
special attention is required for safety of the
patient, or when special care should be
exercised to prevent improper operation of the
device that may cause damage.
CAUTION (Definition)
Cautions are used to alert the user to exercise
special care for the safe use of the device.
DESCRIPTION
The CentriMag RVAD (“Blood Pump”) has a spinning
impeller that imparts rotary motion to the incoming
blood, directing it through the outlet port. When used
as a right ventricular support system, blood from the
failing right heart is directed from the right ventricle or
atrium to the inlet of the pump via an inlet cannula.
Blood exits through the outlet of the pump, through the
outlet cannula, and ultimately to the pulmonary
circulation.
Figure 1 – CentriMag RVAD
The CentriMag Blood Pump couples to a magnetic
drive motor which is connected to a console. The
CentriMag Blood Pump, magnetic drive motor and
console comprise the CentriMag Right Ventricular
Assist System (RVAS).
ADVERSE EVENTS
Based on a review of the published literature on other
ventricular assist devices, the risks usually associated
with use of these devices and from a review of the data
obtained from the CentriMag VAD worldwide
experience, potential medical risks associated with use
of the CentriMag VAD include:
•
Death
•
Stroke
•
Bleeding
•
Reoperation
•
Hemolysis
•
Infection (all cause)
•
Renal failure or dysfunction
•
Respiratory dysfunction
•
Hepatic Dysfunction
•
Cardiac arrhythmias (atrial or ventricular)
•
Limb ischemia or loss of limb
•
Myocardial Infarction
•
Neurological dysfunction
•
Thromboembolism
•
Mechanical or electrical malfunction or possible
failure
•
Psychiatric events
•
Hypotension
•
Hypertension
In addition, risks due to the implantation procedure or
anesthesia may also occur.
HOW SUPPLIED
Each CentriMag RVAD Kit contains the following sterile
components:
Contents of the CentriMag RVAD Kit
DESCRIPTION
QUANTITY
CentriMag Blood Pump
1
CentriMag Inlet Cannula
1
CentriMag Outlet Cannula
1
Tubing Set
2
3/8” Straight Connector
2
CLINICAL SUMMARY
Patients that received a CentriMag RVAD suffered right
ventricular failure after placement of either a
commercially available left ventricular assist device
(LVAD) or after placement of a CentriMag LVAD.
These patients were enrolled either intraoperatively or
postoperatively. The CentriMag RVAD was used for
short-term support until recovery, transplantation or
implantation with a long term device. A total of 24
patients were implanted with a CentriMag RVAD in
U.S. clinical studies. Ten patients received a CentriMag
RVAD after placement of a commercially available
