Potential Complications - Merit Medical Embosphere Mode D'emploi

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.
PAE Specific Warnings
• A thorough clinical evaluation should be performed on all patients
presenting for embolization for BPH (e.g., urinalysis, digital rectal
exam, symptom scores, prostate imaging, prostate-specific antigen
test, transrectal ultrasound) to rule out prostate cancer.
• Because of the tortuous vessels and duplicative feeding arteries in
the pelvic area, extreme caution should be used when performing
prostatic artery embolization (PAE). Complications of mistargeted
embolization include ischemia of the rectum, bladder, scrotum, penis
or other areas.
• When using Embosphere Microspheres for prostatic artery
embolization, do not use microspheres smaller than 100 microns. It is
recommended to use 300-500 microns.
• Due to expected ischemia and inflammation post embolization, PSA
level at 24 hours post procedure may be 10-20 times higher than
baseline value, but by one month will be reduced by approximately
half relative to baseline.
Warnings About PAE and Fertility
• The effects of PAE on fertility have not been determined. Therefore,
this procedure should not be performed on men wanting to father
a child.
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).
PAE Specific Precautions
• The PAE procedure should only be performed by interventional
radiologists who have received appropriate training.
• Collateral circulation may be present and can dilate and supply
adjacent arteries as resistance within the prostatic bed increases.
Therefore, there is potential for severe complications with nontargeted
embolization.
• There is an increased chance of retro-migration of Embosphere
Microspheres into unintended blood vessels as prostatic artery flow
diminishes. Embolization should be stopped when the vasculature
surrounding the prostate can no longer be visualized but before
complete stasis in the prostatic artery.
• Transurethral resection of the prostate (TURP) in patients without
prostate cancer and robot assisted radical prostatectomy in patients
with prostate cancer resulted in reduced blood loss during surgery
after prostatic artery embolization compared to historical controls.
There were no changes in histopathology in malignant tissue post
embolization compared to pre-PAE biopsy findings. The impact of PAE
on subsequent treatments such as HIFU or radiotherapy are unknown.

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
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