InterValve V8 Instructions D'utilisation page 6

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
procedures may 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 D.1
1
. BAV
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