Potential Complications - HeartWare Ventricular Assist System Instructions For Use Manual

Do not dispose of a battery in fire or water. Dispose of batteries according to federal, regional, and local regulations.
25)
26) Keep the battery away from children.
Avoid exposing the battery to excessive shock or vibration.
27)
Do not use a damaged battery.
28)
29) If a battery pack is leaking fluid, do not touch the fluid. Dispose of a leaking battery pack. In case of eye contact with fluid, do not rub eyes. Immediately flush eyes thoroughly with water for
at least 15 minutes, lifting upper and lower lids, until no evidence of the fluid remains. Seek medical attention.
The DC adapter is for use in vehicles only and may not fit in some vehicles.
30)
31) The "Set Defaults" button on monitor REF 1511 (no longer being placed on the market) will erase all patient VAD parameter information from the controller.
DO NOT allow patients to touch the monitor.
32)
33) Never clean the monitor or battery charger with the power on. DO NOT use alcohol or detergent on the monitor display. Gently wipe the display with a soft, lint free cloth.
34) The monitor's internal battery should be fully charged prior to patient use.
Do not attempt to repair or service any components of the HeartWare
35)
Precautions Related To The Vascutek
1) DO NOT preclot. Gelweave prostheses are sealed grafts and must not be preclotted.
The Gelweave prostheses must be implanted within one month after removal from the foil pouch.
2)
Clamping may damage any vascular prostheses. Atraumatic clamps, ideally with soft shod jaws, should be used with a minimum application of force.
3)
4) Excessive tension or force should be avoided, as it will damage the polyester fibers and the gelatin impregnation.
Round body taper point needles should be used when implanting these prostheses to minimize fiber damage.
5)
Use the smallest possible needle for de-airing, 19 gauge is normally sufficient. Hypodermic needles have a cutting point, which may result in blood leakage and may require repair by suturing.
6)
7) Gelweave is based on a woven structure and may be cut with a cautery to minimize fraying. Note: Immersion of the Gelweave prosthesis in saline immediately prior to use will prevent focal
burning, which may result during cauterization. Grafts should be immersed in saline for no longer than 5 minutes.
8) The foil pouch and outer tray are not sterile. Only the innermost tray may be introduced to the sterile field.

5.0 POTENTIAL COMPLICATIONS

Implantation of a Ventricular Assist Device (VAD) is an invasive procedure requiring general anesthesia, a median sternotomy, a ventilator and cardiopulmonary bypass. These surgical procedures are
associated with numerous risks. All VAD patients face risks including, but not limited to:
Air embolism
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Aortic insufficiency
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Arterial non CNS
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thromboembolism
Battery related Injury
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Bleeding, perioperative or late
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Cardiac arrhythmias
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Death
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Device malfunction/failure
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Device thrombosis
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Driveline infection
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Additional risks associated with a textured inflow cannula include:
Embolization of sintered spheres
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Embolization of tissue adherent to inflow at time of pump removal
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System. If HeartWare
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® Gelweave ™ Graft
Driveline perforation Injury from device exposure to
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Driveline wire damage therapeutic ionizing radiation
Electrostatic Discharge Injury from device exposure to
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(ESD) Damage to Controller therapeutic levels of
Erosions and other tissue ultrasound energy
damage Injury from high electrical
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Gastrointestinal bleeding/ AV power sources
malformations Interference with/from
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Hemolysis other devices
Hepatic dysfunction Local infection
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Hypertension Multi-organ failure
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Ventricular Assist System
System equipment malfunctions, contact HeartWare.
®
Myocardial infarction
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Neurologic dysfunction
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Organ damage during
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driveline tunneling
Pericardial effusion
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tamponade
Platelet dysfunction
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Psychiatric episodes
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Renal dysfunction
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Re-operation
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Respiratory dysfunction
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CaUTiOn: The HeartWare
patients with mechanical valves and therefore the risks are currently unknown.
Caution should be used in selecting patients with mechanical valves for
HeartWare Ventricular Assist System therapy.
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Right heart failure
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Sensitivity to aspirin
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Sepsis/major infection
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Stroke
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Venous thromboembolism
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Worsening heart failure
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Wound dehiscence
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® Ventricular Assist System has had limited use in
Instructions For Use
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