The patient had a concomitant surgical procedure of mitral valve replacement through sternotomy.During the same procedure a cryoflex probe powered by a cryoconsole, and cardioblate lp clamps powered by a ft-10 generator were used.The left atrial appendage was successfully amputated/excised and over-sewn.Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block were successfully achieved.Three days post index procedure, the patient experienced hematological acute blood loss anemia.The patient's hemoglobin had drifted down to 6.9g/dl and it was treated with two units of red blood cells the patient recovered on the following day.The adverse event was deemed by the site as possibly related to the concomitant procedure but not related to the study devices or the study procedure.The site stated that this was a common occurrence following cardiac surgery.The clinical events committee (cec) deemed a relationship between the concomitant procedure and study procedure to the adverse event and a possible relationship to the study devices with the exception of the cryoconsole.The cec deemed that the adverse event was not related to the cryoconsole.
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