Possible Complications; Intended Use; Contraindications - Abiomed ImpellaCP Manuel D'utilisation

Never advance the guidewire or sheath when resistance is met.
Determine the cause of resistance using fluoroscopy and take remedial
action
When injecting or aspirating through the sheath, use the sideport
only.
Operation of the system without heparin in the purge solution has not
been tested. In the event that a patient is intolerant to heparin, due to
heparin-induced thrombocytopenia or bleeding, physicians should use
their clinical judgment to assess the risks versus benefits of operating
the Impella System without heparin. If it is in the best interest of the
patient to operate the system without heparin, the glucose solution is still
required, and physicians should consider systemic delivery of an alternative
anticoagulant. Do NOT add any alternative anticoagulant (such as a
direct thrombin inhibitor) to the purge fluid. The Impella Catheter has not
been tested with any alternative anticoagulants in the purge solution.
Do not insert the repositioning sheath into the peel-away sheath during
catheter insertion; slide the repositioning sheath towards the red pump
handle prior to inserting the device.
Never remove the guidewire when increased resistance is met. Determine
the cause of resistance using fluoroscopy and verify the repositioning
sheath is not inserted into the peal-away sheath.
In patients with transcatheter aortic valves position the Impella system
carefully to avoid interaction with the TAV prosthesis. In this situation,
avoid repositioning while the device is running; turn the device to P0
during repositioning or any movement that could bring the outlet
windows into proximity to the valve stent structures. If there is low
flow observed in a patient implanted with a transcatheter aortic valve
prosthesis, consider damage of the impeller and replace the Impella
pump as soon as possible.

INTENDED USE

The Impella (intracardiac pump for supporting the left ventricle) is intended
for clinical use in cardiology and in cardiac surgery for up to 5 days for the
following indications, as well as others:
• The Impella is a circulatory support system for patients with reduced
left ventricular function, eg, post-cardiotomy, low output syndrome,
cardiogenic shock after acute myocardial infarction, or for myocardial
protection after acute myocardial infarction
• The Impella may also be used as a cardiovascular support system
during coronary bypass surgery on the beating heart, particularly in
patients with limited preoperative ejection fraction with a high risk of
postoperative low output syndrome
• Support during high risk percutaneous coronary intervention (PCI)
• Post PCI

CONTRAINDICATIONS

• Mechanical aortic valves, severe aortic valvular stenosis or valvular
regurgitation
• Hematological disorder causing fragility of the blood cells or hemolysis
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aneurysm or necrotomy or severe anomaly of the ascending aorta and/
or the aortic arch
• Mural thrombus in the left ventricle
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump
• Severe peripheral arterial occlusion disease (PAOD) is a relative
contraindication
2

POSSIBLE COMPLICATIONS

There are risks of complications with every procedure using a blood pump.
These include among others:
• Hemolysis
• Bleeding
• Limb ischemia
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Positioning problems causing haemolysis or reduced haemodynamic
support
• Infection and septicemia
• Dislocation of the pump
• Cardiovalvular injuries due to extreme movement of the suction
cannula in relation to the cardiac valve or as a result of attachment by
suction of the pump to the valve system following incorrect positioning
• Endocardiac injuries as a result of attachment of the pump due to
suction
• Pump failure, loss of pump components following a defect
• Patient dependency on the pump after use for support
OVERVIEW
The Impella Catheter is an intravascular microaxial blood pump that
supports a patient's circulatory system. The Impella Catheter is inserted
percutaneously through the femoral artery and into the left ventricle.
When properly positioned, the Impella Catheter delivers blood from the
inlet area, which sits inside the left ventricle, through the cannula, to the
outlet opening in the ascending aorta. Physicians and device operators
monitor the correct positioning and functioning of the Impella Catheter on
the display screen of the Automated Impella Controller.
The clinical benefit of the Impella CP with SmartAssist is described in the
Summary of Safety and Clinical Performance (SSCP) and can be accessed in
EUDAMED (when operational) or requested from Abiomed Europe GmbH.
This section describes the components of the Impella Catheter and the
Automated Impella Controller, as well as the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella System consists of the following reusable components:
• Automated Impella Controller—provides the user interface, alarm
indications, and portable battery
• Automated Impella Controller cart—for easy transport of the
Automated Impella Controller
SINGLE-USE SYSTEM COMPONENTS
The Impella System also includes the following single-use components:
• Impella Catheter
• Purge cassette
• Introducer kit
• 0.018 inch, 260 cm placement guidewire
IMPELLA SET-UP AND INSERTION KIT
The Impella Catheter and the Single-Use components provided by Abiomed
for the set-up and insertion of the Impella Catheter are provided in the
Impella Set.
The Impella CP with SmartAssist
® ®
• Impella CP ® with SmartAssist ®
• 0.018 inch, 260 cm placement guidewire
• Purge cassette
• Introducer kit
» Peel-away introducers - two 14 Fr introducers (13 cm and 25 cm)
»
Dilators - 8 Fr, 10 Fr, 12 Fr, and 14 Fr
» 0.035 inch stiff access guidewire
Set contains:
Catheter
User Manual