Merit Medical QuadraSphere Microspheres User Manual

QQuadraSphere® Microspheres

INSTRUCTIONS FOR USE

INTENDED USE:

QuadraSphere

®

Microspheres are indicated for
embolization of hypervascularized tumors and peripheral
arteriovenous malformations.

DESCRIPTION:

QuadraSphere Microspheres are part of a family of embolic
agents based on proprietary technologies. They are
designed for controlled, targeted embolization.
QuadraSphere Microspheres are biocompatible,
hydrophilic, non-resorbable, expandable, and conformable
microspheres. QuadraSphere Microspheres swell upon
exposure to aqueous solutions. They are available in a
range of sizes.

DEVICE PACKAGING:

QuadraSphere Microspheres are contained in a sterile, 10
ml Cyclic Olefin Copolymers (COC) vial, with a crimped cap,
packaged in a sealed pouch.
Contents: 25 mg (nominal) of dry QuadraSphere
Microspheres per vial to be reconstituted in NaCl 0.9%
aqueous solution before use (or aqueous solution of
equivalent ionic concentration).

CONTRAINDICATIONS:

• Patients intolerant to vascular occlusion procedures

• Vascular anatomy or blood flow precluding correct
catheter placement or embolic injection

CAUTION: Federal (U.S.A.) law restricts this
device to sale by or on the order of a physician.

Dry (µm)

30-60

50-100
100-150
150-200

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• Presence or suspicion of vasospasm

• Presence or likely onset of haemorrhage

• Presence of severe atheromatous disease

• Feeding arteries too small to accept the selected
QuadraSphere Microspheres

• Presence of collateral vessel pathways potentially
endangering normal territories during embolization

• High flow arteriovenous shunts or fistulae with luminal
diameter greater than the selected size of QuadraSphere
Microspheres

• Vascular resistance peripheral to the feeding arteries
precluding passage of QuadraSphere Microspheres into the
lesion

• Presence of arteries supplying the lesion not large enough
to accept QuadraSphere Microspheres

• Do not use in pulmonary vasculature, coronary and
central nervous system vasculature

• Known sensitivity to poly vinyl alcohol-co-sodium
acrylate

WARNINGS:

• QuadraSphere Microspheres size must be chosen after
consideration of the arteriovenous angiographic
appearance. QuadraSphere Microspheres size should be
selected to prevent passage from any artery to vein.

• Some of the QuadraSphere Microspheres may be slightly
outside of the range, so the physician should be sure to
carefully select the size of QuadraSphere Microspheres
according to the size of the target vessels at the desired
level of occlusion in the vasculature and after consideration
of the arteriovenous angiographic appearance.

• 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 can include blindness,
hearing loss, loss of smell, paralysis, and death.

• Serious radiation induced skin injury may occur to the
patient due to long periods of fluoroscopic exposure, large
patient, angled x-ray projections and multiple image
recording runs or radiographs. Refer to your facility’s
clinical protocol to ensure the proper radiation dose is
applied for each specific type of procedure performed.

• Onset of radiation injury to the patient may be delayed.
Patients should be counselled on potential radiation effects,
what to look for and who to contact if symptoms occur.

• QuadraSphere Microspheres MUST NOT be reconstituted
in sterile water for injection. Reconstitution in sterile water
results in extensive swelling that renders the injection of
QuadraSphere Microspheres very difficult or may prevent
injection.

• Do not reconstitute QuadraSphere Microspheres with
Lipiodol / Ethiodol.

• Pay careful attention for signs of mistargeted
embolization. During injection carefully monitor patient vital
signs to include SaO

(e.g. hypoxia, CNS changes). Consider

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terminating the procedure, investigating for possible
shunting, or increasing Microspheres size if any signs of
mistargeting occur or patient symptoms develop.

• Consider upsizing the Microspheres if angiographic

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evidence of embolization does not quickly appear evident
during injection of the Microspheres.

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 of intolerant, non targeted tissue such as nervous
tissue.

PRECAUTIONS:

QuadraSphere Microspheres must only be used by
physicians trained in vascular embolization procedures. The
size and quantity of microspheres must be carefully
selected according to the lesion to be treated and the
potential presence of shunts. Only the physician can decide
the most appropriate time to stop the injection of
QuadraSphere Microspheres.
Do not use if the vial, cap, or pouch appear 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.
QuadraSphere Microspheres MUST NOT be used in their
original dry state. They must be reconstituted before use.
QuadraSphere Microspheres swell in aqueous solution. The
magnitude of swelling depends on the ionic concentration
of the solution. The microspheres swell to approximately

four times their diameter in 0.9% NaCl aqueous solution
and non-ionic contrast media, as compared to their initial
dry diameter. QuadraSphere Microspheres are
compressible and can be injected easily through
microcatheters. However, injection of the QuadraSphere
Microspheres before they are fully expanded could result in
failure to reach the intended embolization target and
possible embolization of a larger tissue area.
Patients with known allergies to non-ionic contrast media
may require corticosteroids prior to embolization.
Additional evaluations or precautions may be necessary in