|PAE n (%)||Relationship With Device or Procedure|
|Total PAE||2 (3.8)|
|Thromboembolism||1 (1.9)||Possibly related to device; probably related to procedure|
|Transient ischemic attack||0||—|
|Phrenic nerve paralysis||0||—|
|Major vascular access complication or bleeding||1 (1.9)||Not related to device; possibly related to procedure|
PAE = primary adverse event; PV = pulmonary vein.
↵∗ Device- or procedure-related death, PV stenosis, and atrioesophageal fistula that occur >1 week (7 days) post-procedure are considered and analyzed as PAE.