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Potential Complications/Outcomes/Adverse Events
• There is potential for balloon separation following balloon rupture or misuse and the
subsequent need to use a snare or other medical interventional techniques to retrieve
device fragments. Large diameter balloons are capable of bursting circumferentially
creating device snag points that can inhibit catheter withdrawal.
• Moderate to severe subannular/left ventricular outflow tract (LVOT) calcification has been
associated with increased risk of aortic root rupture during transcatheter aortic valve
replacement (TAVR) procedures with balloon-expandable prostheses
be similarly cautioned.
• Cardiac or Vascular Perforation or Dissection
• Conduction System Injury Requiring a Temporary or Permanent Pacemaker
• Supraventricular or Ventricular Tachyarrhythmia Development
• Hematoma or Severe Vascular Injury Resulting in Transfusion, Surgical Repair or Loss of
Limb
• Anaphylaxis or Other Contrast Reactions Including Acute Renal Failure
Following Balloon Rupture
• Restenosis Development
• Death
• Thromboembolic Events Including Stroke
• Cardiovascular Injury Requiring Emergent Surgery
• Valvular Tearing or Trauma Resulting in Severe Aortic Regurgitation
• Myocardial Infarction
• Hemodynamic Compromise or Shock Requiring Appropriate Intervention Including IAPB
Support or Intubation
• Inflammation or Infection
• Tamponade and Need for Pericardiocentesis
• Lack of significant hemodynamic improvement despite dilatation of the aortic valve
1: Barbanti et al; Circulation. 2013; 128:244-253
1204-001 Revision C.1
1
. BAV procedures may
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