On (b)(6) 2022, a patient underwent an on-pump ascending aorta graft with pulmonary vein isolation and left atrial appendage exclusion.When the surgeon was attempting to go around the left pulmonary veins to perform a pulmonary vein isolation using the oll2 clamp, an unintended perforation was made.Surgeon sutured the perforation, and no complications were observed.The pulmonary vein isolation was then aborted.It was noted that the patient had a large aortic aneurysm which made visibility and access difficult.Post-op the patient was doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
|