Merit Medical Embosphere Microspheres Sterile Vial IFU-US - Manual (Page 3)

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Patients should be counseled on potential radiation side effects and
whom they should contact if they show symptoms.
• Pay careful attention for signs of mistargeted embolization.
During injection carefully monitor patient vital signs to include
SAO2 (e.g. hypoxia, CNS changes). Consider terminating the
procedure, investigating for possible shunting, or increasing
microsphere size if any signs of mistargeting occur or patient
symptoms develop.
• Consider upsizing the microspheres if angiographic evidence of
embolization does not quickly appear evident during injection of
the microspheres.
UFE Specific Warnings
Warnings about UFE and Pregnancy
• The effects of UFE on the ability to become pregnant and carry a
fetus to term, and on the development of the fetus, have not been
determined. Therefore, this procedure should only be performed
on women who do not intend future pregnancy.
• Women who become pregnant following UFE may be at
increased risk for postpartum hemorrhage, preterm delivery,
cesarean delivery, and malpresentation.
• Devascularization of the uterine myometrium resulting from UFE
may theoretically put women who become pregnant following UFE
at increased risk of uterine rupture.
Other UFE Warnings
• When using Embosphere Microspheres for uterine fibroid
embolization, do not use microspheres smaller than 500 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 vial, screw cap, or tray package appears
damaged.
• For single patient use only - Contents supplied sterile - Never
reuse, reprocess, or resterilize the contents of a vial 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.
• 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