10 HVAD® Instructions for Use
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
1.6 Potential Complications
Implantation of a VAD is an invasive procedure requiring general anesthesia and entry
into the thoracic cavity. These surgical procedures are associated with numerous risks. Risks
associated with the implant procedure and use of the device may include, but are not
limited to, the following
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:
– Air Embolism
– Bleeding, perioperative or late
– GI bleeding / AV malformations
– Device Thrombus
– Electrostatic Discharge (ESD) damage
to device
– Driveline Infection
– Local Infection
– Sepsis
– Transient Ischemic Attack (TIA)
– Stroke
(HCVA)
– Pericardial Effusion/ Tamponade
– Suicide
– Cardiopulmonary Arrest
– Multi-organ failure
– Platelet Dysfunction
– Pleural Effusion
tunneling
– Syncope
– Tissue Erosion and other tissue damage
– Worsening Heart Failure
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Other than death, the adverse events are listed
categories.
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