The Company's portfolio of marketed brands comprise, among others, vernakalant IV, or Brinavess, for the rapid conversion of recent onset atrial fibrillation ("AF") to sinus rhythm. Earlier during Brinavess's development, safety concerns led the U.S. Food and Drug Administration ("FDA") to decline approval for Brinavess after a patient with no apparent heart issues had died after being administered the drug during one of its clinical trials. The FDA then mandated a clinical hold on the Brinavess program, which remains in effect in the U.S. Correvio's SEC filings would later characterize the patient death that precipitated the clinical hold as "a single unexpected serious adverse event of cardiogenic shock experienced by a patient with AF who received vernakalant (IV)."