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

microns.
• An appropriate gynecologic work-up should be performed on
all patients presenting for embolization of uterine fibroids (e.g.
gynecologic history, fibroid imaging, endometrial sampling
to rule out carcinoma in patients with abnormal menstrual
bleeding).
• The diagnosis of uterine sarcoma could be delayed by taking
a non-surgical approach (such as UFE) to treating fibroids. It is
important to pay close attention to warning signs for sarcoma
(e.g., rapid tumor growth, postmenopausal with new uterine
enlargement, MRI findings) and to conduct a more thorough
work-up of such patients prior to recommending UFE.
Recurrent or continued tumor growth following UFE should be
considered a potential warning sign for sarcoma and surgery
should be considered.
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 of
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.
PRECAUTIONS:
All Indications
• 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
• Do not use if the syringe, plunger seal, or tray package appear
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 Embosphere
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 any
other application.
• Select the size and quantity of Embosphere Microspheres
appropriate for the pathology to be treated.
• Embolization with Embosphere Microspheres should only
be performed by physicians who have received appropriate
interventional embolization training in the region to be treated.
UFE Specific Precautions
• There is an increased chance of retro-migration of Embosphere
Microspheres into unintended blood vessels as uterine artery
flow diminishes. Embolization should be stopped when the
vasculature surrounding the fibroid can no longer be visualized
but before complete stasis in the uterine artery.
• UFE should only be performed by Interventional Radiologists
who have received appropriate training for treatment of uterine
leiomyomata (fibroids).
• The clinical study data on Embosphere Microspheres is limited
to 6 months of follow-up. The UFE patients in this study will
continue to be followed annually for at least three years, and the
information will be updated as necessary to reflect any changes
in the long-term outcome following UFE.
POTENTIAL COMPLICATIONS:
All Indications
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 Embosphere 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
• Vasospasm
• 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 syringe and packaging.
• Use by the date indicated on the syringe 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.
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