Merit Medical Bearing nsPVA - Manual (Page 4)

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WARNINGS FOR ALL INDICATIONS
• PRIOR TO EMBOLIZATION, PROSPECTIVE PATIENTS OR THEIR
REPRESENTATIVES MUST BE PROVIDED AN INFORMED CONSENT
DESCRIBING THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE
USE OF THIS DEVICE. WRITTEN ACKNOWLEDGMENT IS WARRANTED.
• The safety and effectiveness of BEARING nsPVA Embolization
Particles for neurovascular use have not been established.
• Because of the significant complications of misembolization, extreme
caution should be used for any procedures involving the extracranial
circulation encompassing the head and neck, and the physician should
carefully weigh the potential benefits of using embolization against the
risks and potential complications of the procedure. These complications
include blindness, hearing loss, loss of smell, paralysis, and death.
• Neurologic deficit, ischemic stroke or ischemic infarct can occur from
occlusion of normal vessels by this embolic.
• As with any embolization device, patient injury, permanent
disability or death may occur as a result of its use.
• Vascular occlusion should only be performed by physicians possessing
skilled interventional occlusion experience in the territory intended to
be embolized.
• A thorough evaluation of a patient’s medical condition, vascular
pathways and the desired embolization goal is necessary to achieve
successful occlusion. This evaluation should include baseline
angiography to determine the presence of potentially dangerous
collateral pathways. Do not proceed with embolization unless these
pathways can be protected.
• Do not use if protective sterile packaging is opened or damaged.
• Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization
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. Reuse,
reprocessing or resterilization 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.
• Smaller BEARING nsPVA Embolization Particles may be more likely to migrate
distally and result in ischemic infarction because of the potential to block
vessels at the precapillary level and to occlude unintended normal vessels;
however, BEARING nsPVA Embolization Particles of all sizes share this potential.
• Typically the artery will accept less BEARING nsPVA Embolization Particles as
the treatment progresses. Proximal slowing or termination of BEARING
nsPVA Embolization Particles passage may occur when the vessel or
malformation is occluded by prior BEARING nsPVA Embolization Particles,
or in the presence of severe atheromatous disease. Continued infusion may
result in inadvertent reflux into critical arteries, creating the potential for
undesirable ischemic infarction.
• Exercise conservative judgment in determining embolization endpoint.
Terminate infusion before complete vessel occlusion has occurred.
• “Clumping” of BEARING nsPVA Embolization Particles or catheter
obstruction may be a function of contrast dilution volume; ensure that
sufficient volume of the appropriate contrast/saline mix is utilized such
that BEARING nsPVA Embolization Particles are free floating and not
observed as aggregates.
• Should catheter obstruction occur, remove the catheter from the patient
while maintaining gentle suction so as not to dislodge BEARING nsPVA
Embolization Particles still within the catheter lumen. Do not use forceful
injection, guidewires or other instruments to dislodge the blockage. Do
not continue using a catheter which has been obstructed as damage to
the device may have occurred.
• Incomplete occlusion of vascular beds or territories may give rise
to the possibility of postprocedural hemorrhage, development of
alternative vascular pathways, or recurrence of symptoms.
• Postprocedural patient follow-up to assess the continued level of
vascular occlusion is necessary. Angiography may be indicated.
• Serious radiation-induced skin injury may occur to the patient due to long
periods of fluoroscopic exposure, large patient diameter, angled x-ray
projections, and multiple image recording runs or radiographs. Refer to
your facility’s institutional protocol to ensure the proper radiation dose
is applied for each specific type of procedure performed. Physicians should
monitor patients that may be at risk.
• Onset of radiation-induced injury to the patient may be delayed.
Patients should be counseled on potential radiation side effects
and whom they should contact if they show symptoms.
• While it is anticipated that long-term embolization of vascular
structures with BEARING nsPVA Embolization Particles will be
achieved, no guarantee of permanence, cure or benefit can be made.
PRECAUTIONS FOR ALL INDICATIONS
• Patients with known allergy to contrast medium may require
pre-medication prior to embolization.
• Additional evaluations or precautions may be necessary in managing
periprocedural care for patients with the following conditions:
a. Bleeding diathesis or hypercoagulative state;
b. Immunocompromised.
• Sterile and single use product. Never reuse a vial that has been opened. Do
not use if the vial, screw-top cap, or peel pouch appears damaged.
• Ensure cleanliness and attention to technique during preparation
of the device to avoid introducing contaminants.
• The appropriate size particles must be chosen based upon the lesion to be
treated and the measurements taken from the baseline angiography.
• The use of sophisticated imaging equipment is necessary for
successful embolization therapy.
• Appropriate facilities should be available to treat potential
complications of the procedure.
UFE Specific Warnings for Pregnancy
(Specific for Treatment of Leiomyoma Uteri)
• UFE is not intended for women who desire future 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 should be aware that
they may be at increased risk for preterm delivery, cesarean delivery,
malpresentation (incorrect positioning of the baby), postpartum
hemorrhage (post-delivery bleeding), abnormal placentation and small-
for-gestational-age infants.
• Devascularization of uterine myometrium resulting from UFE may
put women who become pregnant following UFE at increased risk
of uterine rupture.
Other UFE Specific Warnings
• Do not use particles smaller than 355 microns.
• An appropriate gynecologic work-up should be performed on all
patients presenting for embolization of uterine fibroids (e.g., endometrial
sampling to rule out carcinoma for patients with abnormal bleeding).
• Devascularization of uterine myometrium resulting from UFE may
put women at increased risk of uterine rupture.
• The diagnosis of uterine sarcoma could be delayed by taking a non-
surgical approach (such as UFE), to treat uterine fibroids. Conduct
a more thorough work-up for patients with warning signs for
sarcoma (e.g., prior pelvic radiation, MRI findings, rapid tumor
growth, postmenopausal with new uterine enlargement). Recurrent
or continued tumor growth following UFE should be considered a
potential warning sign for sarcoma and surgery should be considered.