| (H) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(I) Kidney injury or failure which may be temporary
or permanent (for procedures using certain mechanical thrombectomy
devices).
(J) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(K) Increased risk of bleeding at or away from site
of treatment (when using medications to dissolve clots).
(L) For arterial procedures: distal embolus (fragments
of blood clot may travel and block other blood vessels with possible
injury to the supplied tissue).
(M) For venous procedures: pulmonary embolus (fragments
of blood clot may travel to the blood vessels in the lungs and cause
breathing problems or if severe could be life threatening).
(N) Need for emergency surgery.
(6) Angiography with occlusion techniques (including
embolization and sclerosis) - therapeutic.
(A) For all embolizations/sclerosis:
(i) Injury to or occlusion (blocking) of blood vessel
other than the one intended which may require immediate surgery or
other intervention.
(ii) Hemorrhage (severe bleeding).
(iii) Damage to parts of the body supplied or drained
by the vessel with resulting loss of use or amputation (removal of
body part).
(iv) Worsening of the condition for which the procedure
is being done.
(v) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(vi) Unintended thrombosis (blood clot forming at or
blocking the blood vessel) at access site or elsewhere.
(vii) Loss or injury to body parts with potential need
for surgery, including death of overlying skin for sclerotherapy/treatment
of superficial lesions/vessels and nerve injury with associated pain,
numbness or tingling or paralysis (inability to move).
(viii) Infection in the form of abscess (infected fluid
collection) or septicemia (infection of blood stream).
(ix) Nontarget embolization (blocking of blood vessels
other than those intended) which can result in injury to tissues supplied
by those vessels.
(B) For procedures involving the thoracic aorta and/or
vessels supplying the brain, spinal cord, head, neck or arms, these
risks in addition to those under subparagraph (A) of this paragraph:
(i) Stroke.
(ii) Seizure.
(iii) Paralysis (inability to move).
(iv) Inflammation or other injury of nerves (for procedures
involving blood vessels supplying the spine).
(v) For studies of the blood vessels of the brain:
contrast-related, temporary blindness or memory loss.
(C) For female pelvic arterial embolizations including
uterine fibroid embolization, these risks in addition to those under
subparagraph(A) of this paragraph:
(i) Premature menopause with resulting sterility.
(ii) Injury to or infection involving the uterus which
might necessitate hysterectomy (removal of the uterus) with resulting
sterility.
(iii) After fibroid embolization: prolonged vaginal
discharge.
(iv) After fibroid embolization: expulsion/delayed
expulsion of fibroid tissue possibly requiring a procedure to deliver/remove
the tissue.
(D) For male pelvic arterial embolizations, in addition
to the risks under subparagraph (A) of this paragraph: impotence (difficulty
with or inability to obtain penile erection).
(E) For embolizations of pulmonary arteriovenous fistulae/malformations,
these risks in addition to those under subparagraph (A) of this paragraph:
(i) New or worsening pulmonary hypertension (high blood
pressure in the lung blood vessels).
(ii) Paradoxical embolization (passage of air or an
occluding device beyond the fistula/malformation and into the arterial
circulation) causing blockage of blood flow to tissues supplied by
the receiving artery and damage to tissues served (for example the
blood vessels supplying the heart (which could cause chest pain and/or
heart attack) or brain (which could cause stroke, paralysis (inability
to move) or other neurological injury)).
(F) For varicocele embolization, these risks in addition
to those under subparagraph (A) of this paragraph:
(i) Phlebitis/inflammation of veins draining the testicles
leading to decreased size and possibly decreased function of affected
testis and sterility (if both sides performed).
(ii) Nerve injury (thigh numbness or tingling).
(G) For ovarian vein embolization/pelvic congestion
syndrome embolization: general angiography and embolization risks
as listed in subparagraph (A) of this paragraph.
(H) For cases utilizing ethanol (alcohol) injection,
in addition to the risks under subparagraph (A) of this paragraph:
shock or severe lowering of blood pressure (when more than small volumes
are utilized).
(I) For varicose vein treatments (with angiography)
see paragraph (12) of this subsection.
(7) Mesenteric angiography with infusional therapy
(Vasopressin) for gastrointestinal bleeding.
(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 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) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(F) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(G) Ischemia/infarction of supplied or distant vascular
beds (reduction in blood flow causing lack of oxygen with injury or
death of tissues supplied by the treated vessel or tissues supplied
by blood vessels away from the treated site including heart, brain,
bowel, extremities).
(H) Antidiuretic hormone side effects of vasopressin
(reduced urine output with disturbance of fluid balance in the body,
rarely leading to swelling of the brain).
(8) Inferior vena caval filter insertion and removal.
(A) Injury to or occlusion (blocking) of blood vessel
which may require immediate surgery or other intervention.
(B) Hemorrhage (severe bleeding).
(C) Worsening of the condition for which the procedure
is being done.
(D) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(E) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere including caval thrombosis
(clotting of main vein in abdomen and episodes of swelling of legs).
(F) Injury to the inferior vena cava (main vein in
abdomen).
(G) Filter migration or fracture (filter could break
and/or move from where it was placed).
(H) Risk of recurrent pulmonary embolus (continued
risk of blood clots going to blood vessels in lungs despite filter).
(I) Inability to remove filter (for "optional"/retrievable
filters).
(9) Pulmonary angiography.
(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 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) Contrast nephropathy (kidney damage due to the
contrast agent used during procedure).
(F) Thrombosis (blood clot forming at or blocking the
blood vessel) at access site or elsewhere.
(G) Cardiac arrhythmia (irregular heart rhythm) or
cardiac arrest (heart stops beating).
(H) Cardiac injury/perforation (heart injury).
(I) Death.
(10) Percutaneous treatment of pseudoaneurysm (percutaneous
thrombin injection through the skin versus compression).
(A) Thrombosis (clotting) of supplying vessel or branches
in its territory.
(B) Allergic reaction to thrombin (agent used for direct
injection).
(11) Vascular access - nontunneled catheters, tunneled
catheters, implanted access.
(A) Pneumothorax (collapsed lung).
(B) Injury to blood vessel.
(C) Hemothorax/hemomediastinum (bleeding into the chest
around the lungs or around the heart).
(D) Air embolism (passage of air into blood vessel
and possibly to the heart and/or blood vessels entering the lungs).
(E) Vessel thrombosis (clotting of blood vessel).
(12) Varicose vein treatment (percutaneous (through
the skin), via laser, radiofrequency ablation (RFA), chemical or other
method) without angiography.
(A) Burns.
(B) Deep vein thrombosis (blood clots in deep veins).
(C) Hyperpigmentation (darkening of skin).
(D) Skin wound (ulcer).
(E) Telangiectatic matting (appearance of tiny blood
vessels in treated area).
(F) Paresthesia and dysesthesia (numbness or tingling
in the area or limb treated).
(G) Injury to blood vessel requiring additional procedure
to treat.
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