| (a) Anesthesia.
(1) Epidural.
(A) Nerve damage.
(B) Persistent back pain.
(C) Headache.
(D) Bleeding/epidural hematoma.
(E) Infection.
(F) Medical necessity to convert to general anesthesia.
(G) Brain damage.
(H) Chronic pain.
(2) General.
(A) Permanent organ damage.
(B) Memory dysfunction/memory loss.
(C) Injury to vocal cords, teeth, lips, eyes.
(D) Awareness during the procedure.
(E) Brain damage.
(3) Spinal.
(A) Nerve damage.
(B) Persistent back pain.
(C) Bleeding/epidural hematoma.
(D) Infection.
(E) Medical necessity to convert to general anesthesia.
(F) Brain damage.
(G) Headache.
(H) Chronic pain.
(4) Regional block.
(A) Nerve damage.
(B) Persistent pain.
(C) Bleeding/hematoma.
(D) Infection.
(E) Medical necessity to convert to general anesthesia.
(F) Brain damage.
(5) Deep sedation.
(A) Memory dysfunction/memory loss.
(B) Medical necessity to convert to general anesthesia.
(C) Permanent organ damage.
(D) Brain damage.
(6) Moderate sedation.
(A) Memory dysfunction/memory loss.
(B) Medical necessity to convert to general anesthesia.
(C) Permanent organ damage.
(D) Brain damage.
(7) Prenatal/Early Childhood Anesthesia. Potential
long-term negative effects on memory, behavior, and learning with
prolonged or repeated exposure to general anesthesia/moderate sedation/deep
sedation during pregnancy and in early childhood.
(b) Cardiovascular system.
(1) Cardiac.
(A) Coronary artery bypass.
(i) Acute myocardial infarction (heart attack).
(ii) Hemorrhage (severe bleeding).
(iii) Kidney failure.
(iv) Stroke.
(v) Sudden death.
(vi) Infection of chest wall/chest cavity.
(B) Heart valve replacement by open surgery, structural
heart surgery.
(i) Acute myocardial infarction (heart attack).
(ii) Hemorrhage (severe bleeding).
(iii) Kidney failure.
(iv) Stroke.
(v) Sudden death.
(vi) Infection of chest wall/chest cavity.
(vii) Valve related delayed onset infection.
(viii) Malfunction of new valve.
(ix) Persistence of problem for which surgery was performed,
including need for repeat surgery.
(C) Heart transplant.
(i) Infection.
(ii) Rejection.
(iii) Death.
(D) Coronary angiography (Injection of contrast material
into arteries of the heart), coronary angioplasty (opening narrowing
in heart vessel), and coronary stent insertion (placement of permanent
tube into heart blood vessel to open it).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(E) Percutaneous (through the skin) or minimally invasive
heart valve insertion/replacement.
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Malfunction of new valve.
(xi) Need for permanent pacemaker implantation.
(F) Left atrial appendage closure (closing of small
pouch on left side of heart) - percutaneous (through the skin) or
minimally invasive.
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Device embolization (device moves from intended
location).
(xi) Pericardial effusion (development of fluid in
the sack around the heart) and cardiac tamponade (fluid around heart
causing too much pressure for heart to pump properly).
(G) Patent foramen ovale/atrial septal defect/ventricular
septal defect closure by percutaneous (through the skin) or minimally
invasive procedure (closing of abnormal hole between the chambers
of the heart).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Atrial fibrillation (irregular heart rhythm).
(xi) Pulmonary embolus (development of blood clot that
travels to blood vessels in lungs).
(xii) Device embolization (device moves from where
it is placed).
(xiii) Cardiac perforation (creation of hole in wall
of heart).
(H) Electrophysiology studies (exams of heart rhythm),
arrhythmia ablation (procedure to control or stop abnormal heart rhythms).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Rupture of myocardium/cardiac perforation (hole
in wall of heart).
(xi) Cause or worsening of arrhythmia (damage to heart
electrical system causing abnormal heart rhythm), possibly requiring
permanent pacemaker implantation, possibly life threatening.
(xii) Pulmonary vein stenosis (narrowing of blood vessel
going from lung to heart.
(I) Pacemaker insertion, AICD insertion (implanted
device to shock the heart out of an abnormal rhythm).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy (kidney damage due to the
contrast agent used during the procedure).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Rupture of myocardium/cardiac perforation (hole
in wall of heart).
(xi) Cause or worsening of arrhythmia (damage to heart
electrical system causing abnormal heart rhythm), possibly requiring
permanent pacemaker implantation, possibly life threatening.
(xii) Device related delayed onset infection (infection
related to the device that happens at some time after surgery).
(J) Electrical cardioversion (shocking the heart out
of an abnormal rhythm).
(i) Heart arrhythmias (abnormal heart rhythm), possibly
life threatening.
(ii) Skin burns on chest.
(K) Stress testing.
(i) Acute myocardial infarction (heart attack).
(ii) Heart arrhythmias (abnormal heart rhythm), possibly
life threatening.
(L) Transesophageal echocardiography (ultrasound exam
of the heart from inside the throat).
(i) Sore throat.
(ii) Vocal cord damage.
(iii) Esophageal perforation (hole or tear in tube
from mouth to stomach).
(M) Circulatory assist devices (devices to help heart
pump blood).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
(vii) Stroke.
(viii) Contrast nephropathy or other kidney injury
(kidney damage due to the contrast agent used during the procedure
or procedure itself).
(ix) Thrombosis (blood clot forming at or blocking
the blood vessel) at access site or elsewhere.
(x) Hemorrhage (severe bleeding) possibly leading to
sudden death.
(xi) Hemolysis (blood cells get broken apart).
(xii) Right heart failure (poor functioning of the
side of heart not assisted by device).
(xiii) Acquired von Willebrand syndrome (platelets
do not work).
(xiv) Arrhythmia (irregular or abnormal heart rhythm).
(xv) Cardiac or vascular injury or perforation (hole
in heart or blood vessel).
(xvi) Limb ischemia (lack of blood flow or oxygen to
limb that device placed through).
(xvii) Device migration or malfunction.
(xviii) Exposure of device/wound break down with need
for surgery to cover/reimplant.
(N) Extracorporeal Membrane Oxygenation (ECMO).
(i) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(ii) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(iii) Hemorrhage (severe bleeding).
(iv) Myocardial infarction (heart attack).
(v) Worsening of the condition for which the procedure
is being done.
(vi) Sudden death.
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