| (A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure
is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy or other kidney injury (kidney
damage due to the contrast agent used during the procedure or procedure
itself).
(I) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(J) Hemorrhage (severe bleeding) possibly leading to
sudden death.
(K) Hemolysis (blood cells get broken apart).
(L) Right heart failure (poor functioning of the side
of heart not assisted by device).
(M) Acquired von Willebrand syndrome (platelets do
not work).
(N) Arrhythmia (irregular or abnormal heart rhythm).
(O) Cardiac or vascular injury or perforation (hole
in heart or blood vessel).
(P) Limb ischemia (lack of blood flow or oxygen to
limb that device placed through).
(Q) Device migration or malfunction.
(R) Exposure of device/wound break down with need for
surgery to cover/reimplant.
(14) Extracorporeal Membrane Oxygenation (ECMO).
(A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention including
emergency open heart surgery.
(B) Arrhythmia (abnormal heart rhythm), possibly life
threatening.
(C) Hemorrhage (severe bleeding).
(D) Myocardial infarction (heart attack).
(E) Worsening of the condition for which the procedure
is being done.
(F) Sudden death.
(G) Stroke.
(H) Contrast nephropathy or other kidney injury (kidney
damage due to the contrast agent used during the procedure or procedure
itself).
(I) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(J) Thrombocytopenia (low platelets) or other coagulopathy
(blood thinning).
(K) Vascular or cardiac perforation (hole in blood
vessel or heart).
(L) Seizure.
(M) Device migration or malfunction.
(N) Ischemia to limb (lack of blood flow or oxygen
to limb that device placed through).
(O) Thromboembolism (blood clots in blood vessels or
heart and possibly traveling to blood vessels in lungs).
(b) Vascular.
(1) Open surgical repair of aortic, subclavian, iliac,
or other artery aneurysms or occlusions, arterial or venous bypass
or other vascular surgery.
(A) Hemorrhage (severe bleeding).
(B) Paraplegia (unable to move limbs) (for surgery
involving the aorta or other blood vessels to the spine).
(C) Damage to parts of the body supplied or drained
by the vessel with resulting loss of use or amputation (removal of
body part).
(D) Worsening of the condition for which the procedure
is being done.
(E) Stroke (for surgery involving blood vessels supplying
the neck or head).
(F) Kidney damage.
(G) Myocardial infarction (heart attack).
(H) Infection of graft (material used to repair blood
vessel).
(2) Angiography (inclusive of aortography, arteriography,
venography) - Injection of contrast material into blood vessels.
(A) Injury to or occlusion (blocking) of artery which
may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by the artery
or drained by the vessel with resulting loss of use or amputation
(removal of body part).
(D) Worsening of the condition for which the procedure
is being done.
(E) Stroke and/or seizure (for procedures involving
blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory
loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation
of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(3) Angioplasty (intravascular dilatation technique).
(A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by the artery
or drained by the vessel with resulting loss of use or amputation
(removal of body part).
(D) Worsening of the condition for which the procedure
is being done.
(E) Stroke and/or seizure (for procedures involving
blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory
loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation
of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(J) Failure of procedure or injury to blood vessel
requiring stent (small, permanent tube placed in blood vessel to keep
it open) placement or open surgery.
(4) Endovascular stenting (placement of permanent tube
into blood vessel to open it) of any portion of the aorta, iliac or
carotid artery or other (peripheral) arteries or veins.
(A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by the artery
or drained by the vessel with resulting loss of use or amputation
(removal of body part).
(D) Worsening of the condition for which the procedure
is being done.
(E) Stroke and/or seizure (for procedures involving
blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory
loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation
of nerves (for procedures involving blood vessels supplying the spine).
(H) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(I) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(J) Failure of procedure or injury to blood vessel
requiring stent (small, permanent tube placed in blood vessel to keep
it open) placement or open surgery.
(K) Change in procedure to open surgical procedure.
(L) Failure to place stent/endoluminal graft (stent
with fabric covering it).
(M) Stent migration (stent moves from location in which
it was placed).
(N) Impotence (difficulty with or inability to obtain
penile erection) (for abdominal aorta and iliac artery procedures).
(5) Vascular thrombolysis (removal or dissolving of
blood clots) - percutaneous (through the skin) (mechanical or chemical).
(A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Damage to parts of the body supplied by the artery
or drained by the vessel with resulting loss of use or amputation
(removal of body part).
(D) Worsening of the condition for which the procedure
is being done.
(E) Stroke and/or seizure (for procedures involving
blood vessels supplying the spine, arms, neck or head).
(F) Contrast-related, temporary blindness or memory
loss (for studies of the blood vessels of the brain).
(G) Paralysis (inability to move) and inflammation
of nerves (for procedures involving blood vessels supplying the spine).
Cont'd... |
