Abbott Heartmate 3, Руководство для пациента

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Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000
HeartMate3.com
Rx Only
Important Safety Information
Brief Summary: Prior to using these devices, review the Instructions for Use for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short- and long-term
mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in
patients with advanced refractory left ventricular heart failure.
Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot
tolerate, or who are allergic to, anticoagulation therapy.
Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 Left Ventricular Assist
System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device
malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related),
hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous
system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial
infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or device thrombosis.
™ Indicates a trademark of the Abbott group of companies.
© 2020 Abbott. All Rights Reserved.
MAT-2002480 v2.0 | Item approved for U.S. use only.