Merit Medical Embosphere Microspheres Sterile Vial IFU-US - Manual (Page 4)

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• Recanalization
• Foreign body reactions necessitating medical intervention
• Infection necessitating medical intervention
• 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
• Death
• Blindness, hearing loss, loss of smell, and/or paralysis
• Additional information is found in the Warnings section
UFE Specific Potential Complications
• The most frequently anticipated post procedure complications
are abdominal pain, discomfort, fever and/or nausea, collectively
known as “Post-embolization Syndrome.” Some patients may also
experience constipation.
This is generally managed with
prescription or over the counter medications.
• Premature ovarian failure (i.e. Menopause)
• Amenorrhea
• Infection of the pelvic region
• Uterine/ovarian necrosis
• Phlebitis
• Deep vein thrombosis with or without pulmonary embolism
• Vaginal discharge
• Tissue passage, fibroid sloughing, or fibroid expulsion post UFE
• Post-UFE intervention to remove necrotic fibroid tissue
• Vagal reaction
• Transient hypertensive episode
• Hysterectomy
• As of November 2002, four known deaths have occurred in
approximately 25,000 to 30,000 women treated by UFE world
wide, for a death rate of 0.01 to 0.02 percent.
Neurological Specific Potential Complications
• Ischemic stroke or ischemic infarction
• Neurological deficits, including cranial nerve palsies
STORAGE AND STERILITY:
• Embosphere Microspheres must be stored in a cool, dry and dark
place in their original vial and packaging.
• Use by the date indicated on the vial label.
• Do not freeze.
• Do not resterilize.
INSTRUCTIONS FOR USE:
Inspect packaging prior to use to ensure seal integrity for
maintenance of sterility.
• Carefully evaluate the vascular network associated with the lesion
using high resolution imaging prior to beginning the embolization
procedure.
• Embosphere 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 Embosphere 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 Embosphere Microsphere size that will occlude the nidus
without passing through the AVM.
• When embolizing uterine fibroids, choose an Embosphere
Microsphere size of 500 microns or greater.
• Choose a delivery catheter based on the size of the target vessel
and the microsphere size being used. Embosphere Microspheres
can tolerate temporary compression of up to 33% in order to
facilitate passage through the delivery catheter.
• Introduce the delivery catheter into the target vessel according to
standard techniques. Position the catheter tip as close as possible
to the treatment site to avoid inadvertent occlusion of normal
vessels.
• Embosphere Microspheres are not radiopaque.
It is
recommended that the embolization be monitored using
fluoroscopic visualization by adding the appropriate amount of
contrast medium to the physiologic suspension fluid.
• To deliver Embosphere Microspheres:
After gently agitating the vial containing Embosphere Microspheres,
dilute Embosphere Microspheres with contrast medium either into
a small sterile cup or directly into a large, mixing syringe. It is
recommended that 50% contrast and 50% physiological saline be
used for best suspension. To ensure proper suspension, gently
agitate the mixture of Embosphere Microspheres and contrast and
wait 2-3 minutes after mixing, prior to injection.
Draw the
Embosphere Microspheres/contrast solution into a 1 mL or 3 mL
injection syringe and attach the syringe to the delivery catheter.
Inject the Embosphere Microspheres/contrast solution into the
delivery catheter under fluoroscopic visualization using a slow
pulsatile injection while observing the contrast flow rate. If there is
no effect on the flow rate, repeat the delivery process with additional
injections of the Embosphere Microspheres/contrast solution.
Consider using larger sized Embosphere Microspheres if the initial
injections do not alter the contrast flow rate. Exercise conservative
judgment in determining the embolization endpoint.
• Femoral puncture can result in arterial spasm. This may
predispose to femoral thrombosis (e.g. leg injury). Femoral patency
should be re-assessed prior to final catheter removal.
• Upon completion of the treatment, remove the catheter while
maintaining gentle suction so as not to dislodge Embosphere
Microspheres still within the catheter lumen.
• Apply pressure to the puncture site until hemostasis is complete.
• Discard any open, unused Embosphere Microspheres.
Additional UFE specific instructions:
• At the discretion of the physician, pneumatic compression
devices may be used for patients currently taking hormone
therapy, uterine volume >1000cc, and patients that are overweight
to lower the risk of deep vein thrombosis.
• Embolization should be stopped when the vasculature
surrounding the fibroid can no longer be visualized but before
complete stasis in the uterine artery. There is an increased chance
of retro-migration of Embosphere Microsphere into unintended
blood vessels as uterine artery flow diminishes.
UFE PATIENT COUNSELING INFORMATION:
• Patients should have a clear understanding prior to embolization
of who will provide their post procedure care and whom to contact
in case of an emergency after embolization. Patient information
brochures are available and distributed by BioSphere Medical, Inc.
• UFE candidates should have an understanding of the potential
benefits, risks, and adverse events associated with UFE.
In
particular patients should understand that there is a chance their
fibroid-related symptoms will not improve following UFE.