Abiomed Impella RP User manual

Impella® RP
with the Automated Impella®Controller
Circulatory Support System
INSTRUCTIONS FOR USE
& CLINICAL REFERENCE MANUAL
(United States only)
Humanitarian Device. Authorized by Federal law (USA) to provide circulatory
assistance for up to 14 days in pediatric or adult patients with a body surface
area ≥1.5 m2who develop acute right heart failure or decompensation following
left ventricular assist device implantation, myocardial infarction, heart transplant,
or open-heart surgery. The effectiveness of this device for this use has not been
demonstrated.

IMPORTANT NOTICE: Readthis entire manual beforeusingthe Automated Impella
®
Controller and Impella
®
RPCirculatorySupport
System(Impella
®
RPSystem).TheImpella
®
RPSystem is to be used onlyinaccordance withthismanual.Thismanual is onlyapplicable
toImpella
®
systems using the Automated Impella
®
Controller.
Information containedin this document is subject to change without notice.
©2012 Abiomed
®
, Inc. Allrights reserved.
TheABIOMEDlogoand ABIOMED areregisteredtrademarks of Abiomed, Inc.in theU.S.A. and certain foreign countries.
Recovering hearts.Saving lives. is a trademark of Abiomed, Inc.
Impella is a registered trademark of Abiomed EuropeGmbH, a wholly owned subsidiary of Abiomed, Inc.,in the U.S.A. and certain
foreigncountries.

IMPELLA®RPWITHTHE
AUTOMATEDIMPELLA®CONTROLLER
INSTRUCTIONSFORUSE
&CLINICALREFERENCEMANUAL
(UNITEDSTATESONLY)
Rx Only
Abiomed, Inc.
22 Cherry Hill Drive
Danvers, MA 01923
978-777-5410 (voice)
978-777-8411 (fax)
[e-mail] (email)
Abiomed EuropeGmbH
Neuenhofer Weg 3
52074Aachen,Germany
[phone](voice)
[phone](fax)
[e-mail](email)
www.abiomed.com
24-Hour Emergency Hotlines:
N. America 1-800-422-8666
Europe [phone]
June2012
Document No. 0046-9051 Rev. A

INTRODUCTION
Introduction .....................................................................................................I
1 INDICATIONS,CONTRAINDICATIONS,ANDPOTENTIAL
ADVERSE EVENTS
Indications(UnitedStates)...............................................................................1.1
Contraindications(UnitedStates)...................................................................1.1
PotentialAdverseEvents(UnitedStates)........................................................1.2
2 WARNINGSANDCAUTIONS
Warnings........................................................................................................2.1
Cautions......................................................................................................2.3
3 THEIMPELLA®RPCATHETERANDAUTOMATEDIMPELLA®
CONTROLLER
Overview............................................................................................................3.1
Impella®RPCatheter..................................................................................... 3.3
AutomatedImpella®Controller......................................................................3.5
PurgeCassette.................................................................................................3.6
Accessories.......................................................................................................3.8
4 USINGTHEAUTOMATEDIMPELLA
®
CONTROLLER
Overview ..................................................................................................... 4.1
AutomatedImpella
®
ControllerFeatures.........................................................4.1
AutomatedImpella
®
ControllerDisplay............................................................4.5
PlacementScreen............................................................................................4.8
PurgeScreen.................................................................................................4.9
InfusionHistory............................................................................................4.10
MobileOperation...........................................................................................4.11
5 USINGTHEAUTOMATEDIMPELLA
®
CONTROLLER WITHTHE
IMPELLA
®
RP CATHETER
Startup............................................................................................................5.1
CaseStart......................................................................................................5.4
InsertingtheImpella
®
RPCatheter.................................................................5.10
PositioningandStartingtheImpella
®
RPCatheter...........................................5.12
PerformanceLevels.......................................................................................5.13
Suction..........................................................................................................5.13
UseoftheRepositioningSheathandthe23FrPeel-awayIntroducer....... 5.14
PurgeCassetteProcedures............................................................................5.15
TroubleshootingthePurgeSystem...............................................................5.18
PatientWeaning.......................................................................................... 5.20
RemovingtheImpella
®
RPCatheter.............................................................5.20
6 CLINICALEXPERIENCE
PivotalClinicalStudyDesign–RECOVER RIGHT ................................ 6.1
AccountabilityofCohort……..........................................................................6.3
7 AUTOMATEDIMPELLA
®
CONTROLLERALARMS
AlarmsOverview ........................................................................................7.1
AlarmMessageSummary..........................................................................7.3
8 GENERALSYSTEMINFORMATION
Terminology,Abbreviations,andSymbols.....................................................8.1
AutomatedImpella
®
ControllerMechanicalSpecifications..........................8.3
AutomatedImpella
®
ControllerElectricalSpecifications...............................8.3
EquipmentDesign.........................................................................................8.4
EquipmentClassifications ..........................................................................8.4
FederalCommunicationsCommission(FCC)Notice....................................8.5
ElectromagneticCompatibility......................................................................8.5
TransportBetweenHospitals………………………………………...8.10
TransportWithintheHospital………………………………………...8.11
SlaveMonitorConnection..........................................................................8.11
AlarmDelayInformation.............................................................................8.12
PatientEnvironment....................................................................................8.12
WhiteConnectorCable..............................................................................8.13
Impella
®
RPCatheterParameters...............................................................8.13
Cleaning.....................................................................................................8.14
StoringtheAutomatedImpella
®
Controller.................................................8.14
ReturninganImpella
®
RPCathetertoAbiomed(UnitedStates)..................8.14
APPENDICES
AppendixA:AutomatedImpella
®
ControllerMenuStructure................... A.1
..
TABLEOFCONTENTS

FIGURES
Figure3.1 Impella
®
RPCatheterintheHeart..........................................3.1
Figure3.2 AutomatedImpella
®
Controller,Impella
®
RPCatheter,and
Accessories.............................................................................3.2
Figure3.3 Impella
®
RP Catheter.............................................................3.3
Figure3.4 AutomatedImpella
®
Controller–FrontView........................3.5
Figure3.5 PurgeCassette.................................................................... 3.6
Figure3.6 WhiteConnectorCable.........................................................3.8
Figure 3.7 Introducer kit ......................................................................... 3.8
Figure3.8 0.025inch,260cmPlacementGuidewire............................3.8
Figure3.9 DextroseSolution.................................................................3.9
Figure3.10 AutomatedImpella
®
ControllerCart.......................................3.9
Figure4.1 AutomatedImpella
®
ControllerFeatures–FrontView...........4.1
Figure4.2 AutomatedImpella
®
ControllerFeatures–SideViews..........4.3
Figure4.3 AutomatedImpella
®
ControllerDisplayElements.................4.5
Figure4.4 PlacementScreen...................................................................4.8
Figure4.5 PurgeScreen..........................................................................4.9
Figure4.6 InfusionHistoryScreen........................................................4.11
Figure5.1 AutomatedImpella
®
ControllerPowerSwitch.........................5.2
Figure5.2 AutomatedImpella
®
ControllerStartupScreen.......................5.3
Figure5.3 InitialCaseStartScreen.........................................................5.4
Figure5.4 InsertingthePurgeCassetteintotheAutomatedImpella
®
Controller ............................................................................... 5.5
Figure5.5 InsertingtheCatheterPlugintotheConnectorCable.........5.6
Figure5.6 SnappingPlasticCliptoConnectorCable............................5.6
Figure5.7 PrimingtheImpellaPurgeLumen..........................................5.7
Figure5.8 ConnectingtheLuertotheImpella
®
RPCatheter..................5.7
Figure5.9 EnteringPurgeFluidInformation..........................................5.8
Figure5.10 ConnectingthePurgeTubingtotheConnectorCable...........5.9
Figure5.11 Impella
®
RPSystemConfiguration.........................................5.9
Figure5.12 MaximumPerformanceLevel..................................................5.12
Figure5.13 DisconnectingtheYConnectorfromthePurgeCassette
Tubing......................................................................................5.15
Figure6.1 StudyFlow Schematic …………………………………. 6.3
Figure6.2 Cardiacindexandcentralvenouspressuremeasured
duringthestudy………………………………………….6.8
Figure6.3 LVADflowchangesfrom baselinetoon-support……….6.8
Figure6.4 Useofinotropes duringImpellaRPsupport..…………. 6.9
Figure6.5 Right ventricularfunctionchanges………………………6.10
Figure7.1 AlarmWindow......................................................................7.2
Figure 8.1 AutomatedImpella
®
ControllerPatientEnvironment............8.12
TABLES
Table3.1 Impella
®
RP CatheterComponents ..........................................3.3
Table3.2 PurgeCassetteComponents .................................................... 3.7
Table3.3 Impella
®
RPCatheterandAutomatedImpella
®
Controller
Accessories.................................................................................3.8
Table4.1 AutomatedImpella
®
ControllerFrontViewFeatures..................4.2
Table4.2 AutomatedImpella
®
ControllerSideViewFeatures...................4.4
Table4.3 AutomatedImpella
®
ControllerDisplayElements.....................4.5
Table5.1 PerformanceLevelFlowRates.................................................5.13
Table6.1 Patient Characteristics...............................................................6.4
Table6.2 BaselineLaboratoryParameters………………………….. 6.5
Table6.3 ProceduralCharacteristics …………………………………6.6
Table6.4 SupportandHemodynamicCharacteristics ………………. 6.6
Table6.5 Patient Outcome …………………………………………… 6.7
Table6.6 SecondarySafetyEndpoints ………………………………. 6.7
Table7.1 AlarmLevels..............................................................................7.1
Table7.2 AutomatedImpella
®
ControllerAlarmMessages .....................7.3
TABLEOFCONTENTS

INTRODUCTION
PURPOSE OF MANUAL
This Instructions for Use & Clinical Reference Manual is designed for healthcare professionals. It
contains clinical and technical information to guide healthcare professionals in their use of the
Impella® RP Catheter with the Automated Impella® Controller. The Impella® RP System performs
life-sustaining functions. To use the system you must understand and follow these instructions. The
Impella® RP System may be used only for its intended purpose.
MANUAL OVERVIEW
This manual provides instructions for use of the Impella
®
RP Catheter with the Automated Impella®
Controller. The following summarizes the contents of each section of the manual.
• Section 1: Indications, Contraindications, and Potential Adverse Events discusses
indications for use of the Impella
®
RP Catheter with the Automated Impella
®
Controller,
contraindications, and potential adverse events that may be associated with the use of the
system.
• Section 2: Warnings and Cautions discusses the warnings and cautions pertaining to the
use of the Impella
®
RP Catheter with the Automated Impella
®
Controller.
• Section 3: The Impella® RP Catheter and Automated Impella® Controller provides an
overview of the system and describes its major components and features.
• Section 4: Using the Automated Impella® Controller describes the controls and various
screen types on the Automated Impella® Controller.
• Section 5: Using the Automated Impella® Controller with the Impella® RP Catheter
provides the procedures for using the Impella® RP System.
• Section 6: Clinical Experience provides an overview of the RECOVER RIGHT trial, which
studied the use of the Impella® RP System in a U.S. clinical trial. The results of this trial
were reviewed by the FDA prior to its approval of the Impella® RP System.
• Section 7: Automated Impella® Controller Alarms provides a listing of Automated
Impella® Controller alarms as well as information on what to do to resolve them.
• Section 8: General System Information contains information including definitions for key
terms that appear in the manual, descriptions of the abbreviations and symbols that appear
on Impella® RP Catheter and Automated Impella® Controller components and packaging,
technical information pertaining to the Impella® RP Catheter and Automated Impella®
Controller, and instructions on cleaning and storing system components as well as returning
components to Abiomed.
• Appendices at the end of the manual provide supplemental information about topics
including the Automated Impella® Controller menu structure.
Impella
®
RP with the Automated Impella
®
Controller
I

1 INDICATIONS, CONTRAINDICATIONS,
AND POTENTIAL ADVERSE EVENTS
INDICATIONS (UNITED STATES) ...................................................................... 1.1
CONTRAINDICATIONS (UNITED STATES)…................................................... 1.1
POTENTIAL ADVERSE EVENTS (UNITED STATES) ......................................... 1.2

INDICATIONS (UNITED STATES)
The Impella RP System is indicated for providing circulatory assistance for up to 14 days in pediatric
or adult patients with a body surface area ≥1.5 m
2
who develop acute right heart failure or
decompensation following left ventricular assist device implantation, myocardial infarction, heart
transplant, or open-heart surgery.
CONTRAINDICATIONS (UNITED STATES)
• Disorders of the pulmonary artery wall that would preclude placement or correct positioning
of the Impella RP device
• Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve
or pulmonary valve
• Mural thrombus of the right atrium or vena cava
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump
• Presence of a vena cava filter or caval interruption device, unless there is clear access from
the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter
Impella®RP with the Automated Impella®Controller
1.1

1.2 Instructions for Use & Clinical Reference Manual (US)
POTENTIAL ADVERSE EVENTS (UNITED STATES)
Below is a list of the potential adverse effects (e.g., complications) associated with the use of the
Impella RP system:
• Arrhythmia
• Atrial fibrillation
• Bleeding
• Cardiac tamponade
• Cardiogenic shock
• Death
• Device Malfunction
• Hemolysis
• Hepatic failure
• Insertion site infection
• Perforation
• Phlegmasia cerulea dolens (a severe form of deep venous thrombosis)
• Pulmonary valve insufficiency
• Respiratory dysfunction
• Sepsis
• Thrombocytopenia
• Thrombotic vascular (non-central nervous system) complication
• Tricuspid valve injury
• Vascular injury
• Venous thrombosis
•
Ventricular fibrillation and/or tachycardia

2
WARNINGS AND CAUTIONS
WARNINGS...................................................................................................
2
.1
CAUTIONS...................................................................................................
2
.3