Table 2

Adverse Events Listed in the Instructions for Use for ASO and HSO

Potential Device- or Procedure Related Adverse Events Listed by the Manufacturer for the ASOPotential Device- or Procedure Related Adverse Events Listed by the Manufacturer for the HSO
Air embolusDevice embolization
Allergic reactionNew arrhythmia requiring treatment
Anesthesia reactionsRepeat procedure to the septal defect
ApneaIntervention for device failure or ineffectiveness
FeverAccess site complications requiring surgery, interventional procedure
Hypertension/hypotensionTransfusion or prescription medication
Infection including endocarditisThrombosis or thromboembolic event resulting in clinical sequelae
Perforation of vessel or myocardiumImpingement on, damage to or perforation of a cardiovascular structure by the device
PseudoaneurysmDevice fracture resulting in clinical sequelae or surgical intervention
Blood loss requiring transfusionAir embolism
StrokeMyocardial infarction
Valvular regurgitationPericardial tamponade
DeathCardiac arrest
Renal failure
Sepsis
Significant pleural or pericardial effusion requiring drainage
Significant bleeding
Endocarditis
Headache or migraine
TIA or stroke
Death

Adapted, with permission from AGA (15) and W. L. Gore (16).

ASO = Amplatzer septal occluder; HSO = Helex septal occluder; TIA = transient ischemic attack.