Merit Medical EmboGold Microspheres Prefilled Syringe IFU-US - Manual (Page 4)

• Consider upsizing the microspheres if angiographic evidence of
embolization does not quickly appear evident during injection of
the microspheres.
Warnings about use of small microspheres
• Careful consideration should be given whenever use is
contemplated of embolic agents that are smaller in diameter than
the resolution capability of your imaging equipment. The presence
of arteriovenous anastomoses, branch vessels leading away from
the target area or emergent vessels not evident prior to
embolization can lead to mistargeted embolization and severe
complications.
• Microspheres smaller than 100 microns will generally migrate
distal to anastomotic feeders and therefore are more likely to
terminate circulation to distal tissue. Greater potential ischemic
injury results from use of smaller sized microspheres and
consideration must be given to the consequence of this injury prior
to embolization. The potential consequences include: swelling,
necrosis, paralysis, abscess and/or stronger post embolization
syndrome.
• Post-embolization swelling may result in ischemia to tissue
adjacent to target area. Care must be given to avoid ischemia-
intolerant, nontargeted tissue such as nervous tissue.
PRECAUTION :
• Do not use if the syringe, plunger seal or tray package appears
damaged.
• For single patient use only - Contents supplied sterile - Never
reuse, reprocess, or resterilize the contents of a syringe that has
been opened. Reusing, reprocessing or resterilizing may
compromise the structural integrity of the device and or lead to
device failure, which in turn may result in patient injury, illness or
death. Reusing, reprocessing or resterilizing may also create a risk
of contamination of the device and or cause patient infection or
cross infection including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient.
All procedures must be performed according to accepted aseptic
technique.
• Do not connect the 20 mL syringe with EmboGold Microspheres
directly to a microcatheter for embolic delivery, as a catheter
occlusion may result.
• The syringe is intended for embolic use only. Do not use for
another application.
• Select the size and quantity of EmboGold Microspheres
appropriate for the pathology to be treated.
• Embolization with EmboGold Microspheres should only be
performed by physicians who have received appropriate
interventional occlusion training in the region intended to be
embolized.
• Patients with known allergy to contrast medium may require
corticosteroids prior to embolization.
• Additional evaluations or precautions may be necessary in
managing periprocedural care for patients with the following
conditions :
– Bleeding diathesis or hypercoagulative state
– Immunocompromise.
POTENTIAL COMPLICATIONS :
Vascular embolization is a high-risk procedure. Complications may
occur at any time during or after the procedure, and may include,
but are not limited to, the following:
• Paralysis resulting from untargeted embolization or ischemic
injury from adjacent tissue edema.
• Undesirable reflux or passage of EmboGold Microspheres into
normal arteries adjacent to the targeted lesion or through the lesion
into other arteries or arterial beds, such as the internal carotid
artery, pulmonary, or coronary circulations.
• Pulmonary Embolism due to arterial venous shunting.
• Ischemia at an undesirable location, including ischemic stroke,
ischemic infarction (including myocardial infarction), and tissue
necrosis.
• Capillary bed occlusion and tissue damage.
• Vessel or lesion rupture and hemorrhage.
• Neurological deficits, including cranial nerve palsies.
• Vasospasm.
• Death.
• Recanalization.
• Foreign body reactions necessitating medical intervention.
• Infection necessitating medical intervention.
• Clot formation at the tip of the catheter and subsequent
dislodgment.
• Allergic response to gold.
• Complications related to catheterization (e.g., hematoma at the
site of entry, clot formation at the tip of the catheter and
subsequent dislodgment, and nerve and/or circulatory injuries,
which may result in leg injury).
• Allergic reaction to medications (e.g. analgesics).
• Allergic reaction to contrast media or embolic material.
• Pain and/or rash, possibly delayed from the time of embolization.
• Blindness, hearing loss, loss of smell.
• Additional information is found in the Warnings section.
STORAGE AND STERILITY :
Inspect packaging prior to use to ensure seal integrity for
maintenance of sterility.
• EmboGold Microspheres must be stored in a cool, dry and dark
place in their original syringe and packaging.
• Use by the date indicated on the syringe label.
• Do not freeze.
• Do not resterilize.
INSTRUCTIONS FOR USE :
• Carefully evaluate the vascular network associated with the
lesion using high resolution imaging prior to beginning the
embolization procedure.
• EmboGold Microspheres are available in a range of sizes.
Because of the potential for misembolization and the inherent
variability in sphere sizes, the physician should be sure to carefully
select the size of EmboGold Microspheres according to the size of
the target vessels at the desired level of occlusion in the
vasculature.
• When embolizing arteriovenous malformations (AVM), choose an
EmboGold Microspheres size that will occlude the nidus without
passing through the AVM.
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