Indications, Safety, and Warnings
For use in the treatment of hydrocephalus as a component of a shunt
system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Shunting of CSF into the peritoneal cavity, right atrium, or other
areas of the body should not be carried out if there is infection in
any area of the body. Additionally, shunting in the atrium of patients
with congenital heart disease, or other serious cardiopulmonary
abnormalities, is contraindicated.
Do not implant this device in patients with known hypersensitivity
to rifampin or clindamycin hydrochloride.
Use of this device is contraindicated in patients receiving
anticoagulants or known to have a bleeding diathesis.
Warnings and Precautions
- Do not immerse the ARES catheter in antibiotic solutions. When
immersing the catheter in sterile water or saline, keep the time the
catheter is immersed to a minimum. A pale orange color may be
imparted to the immersion solution.
- Avoid contacting
implantable products with lint, glove talc, oily residue from skin,
oil based soaps, or other surface contaminants. Introduction of
contaminants could result in improper performance of components,
foreign body reactions, or allergic reactions.
- Improper use
of instruments in handling or implanting shunt products may result
in the cutting, slitting or crushing of components. Such damage may
lead to loss of shunt integrity, and necessitate premature surgical
revision of the shunt system.
- Care must be taken to ensure
that particulate contaminants are not introduced into shunt
components during implantation, testing, or handling. Introduction
of contaminants could result in improper performance (over- or
under-drainage) of the shunt system. Particulate matter which enters
the shunt system may result in shunt occlusion, or may hold
pressure/flow controlling mechanisms open, resulting in
- The encircling ligatures used to fasten
catheters to connectors should securely fasten the catheters to the
connectors. However, over-tightening the ligatures could eventually
result in cutting through the silicone tubing.
- Care must be
taken in the routing of catheters to prevent kinking and needless
abrasion along their course. Abrasion can result in premature
catheter failure (fracture). The rim of the twist drill or burr hole
may be trimmed to provide a beveled notch where the ventricular
catheter emerges and is curved to lie adjacent to the skull.
- Patients with hydrocephalus shunt systems must be kept under
close observation in the postoperative period for signs and symptoms
that suggest shunt malfunction. Clinical findings may indicate
infection, shunt obstruction, and/or overdrainage of CSF.
- Shunt obstruction may occur in any component of the shunt
system. The ventricular catheter may become occluded by particulate
matter (e.g. blood clots, brain fragments, and bacterial
colonization), by investment of the catheter tip in choroid plexus,
by embedding of the catheter in brain tissue, or by coaptation of
the ventricular walls in the presence of overdrainage (“slit
ventricles”). Shunt obstruction may occur due to growth of the
child, or physical activities which result in the disconnection of
the shunt components or withdrawal of a distal catheter from its
intended drainage site.
- Separation of the components of a
shunt system due to disconnection or catheter fracture has been
reported. In some cases, the separated shunt components have
migrated into the cerebral ventricles, the heart, or the peritoneal
cavity. Shunt systems may fail due to mechanical malfunction,
leading to under- or over-drainage.
- Malfunction or
obstruction of the shunt system may lead to signs and symptoms of
increased intracranial pressure if the hydrocephalus is not
compensated. In the infant, common symptoms may include increased
tension of the anterior fontanel, congestion of scalp veins,
listlessness, drowsiness and irritability, vomiting and nuchal
rigidity. In older children and adults, common symptoms may include
headaches, vomiting, blurring of vision, nuchal rigidity,
deterioration of consciousness, and various abnormal neurological
- Overdrainage of CSF may predispose development of a
subdural hematoma or hydroma or collapse of the lateral ventricular
walls leading to obstruction of the ventricular catheter.
- If the ventricular catheter becomes bound to the choroid plexus
or adjacent brain tissue by fibrous adhesions, it is suggested that
the catheter should not be removed forcibly. Gentle rotation of the
catheter may help to free it and allow for non-forcible removal. It
is advised that the catheter be left in place rather than risk
intraventricular hemorrhage which may be caused by forcible
- Store this product below 27 °C (80 °F), away from direct
light. Do not remove the product from the packaging until it will be
- Complications associated with ventriculoatrial and
ventriculoperitoneal CSF shunting systems may be similar to those
experienced in any surgical procedure carried out under local and/or
general anesthesia. These include reactions to drugs and anesthetic
agents, electrolyte imbalance, and excessive blood loss,
particularly in infants. On rare occasions, the patient may exhibit
a reaction due to sensitivity to the implant. Use of sharp
instruments while handling these devices can nick or cut the
silicone elastomer, resulting in leakage and necessitating valve
revision. Care must also be taken when closing incisions to ensure
that the valves are not cut or nicked by suture needles.
all CSF shunting procedures, the most common complications are due
to obstruction of the system as described under “Warnings and
Precautions.” Obstruction may occur in any component of the system,
due to plugging by brain fragments, blood clots, and tumor cell
aggregates. Obstructions may also occur because of the separation of
shunt components, or kinking and/or coiling of the catheter. This
may predispose migration of the ventricular catheter into the
lateral ventricle and the distal catheter into the peritoneum, the
heart and pulmonary arterial tree, or any other structure in which
the catheter is implanted.
- Growth of the child may cause
the distal catheter to be withdrawn from the peritoneum into tissue
planes where the fluid cannot be absorbed, or from the atrium into
the internal jugular vein. In addition to the types of shunt
obstructions described above, there are other potentially serious
complications. Local and systemic infections are not uncommon with
shunting procedures. Usually, they are due to organisms inhabiting
the skin, particularly Staphylococcus epidermidis. Other pathogens
circulating in the bloodstream may colonize the shunt and, in the
majority of patients, require its removal.
- In 1973,
Robertson et al. summarized the incidence of infection in
ventriculoatrial and ventriculoperitoneal shunts reported up to that
time. The incidence of infection in ventriculoatrial shunting varied
from 7 to 31%. Infection in ventriculoperitoneal shunting occurred
in 5 to 10% of the patients in most of the reports. Because
ventriculoatrial shunting predisposes the spread of bacteria into
other organs of the body, ventriculoperitoneal shunting is
considered less devastating.
- In 1993, Kestle et al.
reported significant reductions in infection (less than 4%) with the
use of antibiotics, short duration of surgery (surgical experience)
and control of the operating room environment (e.g. designated
operating room, limited personnel and traffic, covered skin
surfaces) The article states that results can also be obtained
without the use of antibiotics, but with rigorous perioperative
control of the environment.
- The use of prophylactic
antibiotics in shunted patients is somewhat controversial because
their use may predispose infection by more resistant organisms. The
decision to use antibiotics prophylactically rests with the
attending physician and/or surgeon.
- Shunting into the
peritoneum may fail because of investments of the catheter in loops
of bowel or in the greater omentum. Perforation of the bowel by the
peritoneal catheter with subsequent development of peritonitis has
- Overdrainage of CSF may result in excessive
reduction of CSF pressure and predispose the development of a
subdural hematoma or hydroma, and excessive reduction of ventricular
size, leading to obstruction because of impingement of the
ventricular walls on the inlet holes in the catheter. In the infant,
this excessive reduction of pressure will cause marked depression of
the anterior fontanel, overriding of cranial bones, and may convert
communicating hydrocephalus into obstructive hydrocephalus.
- The incidence of epilepsy after ventricular shunting procedures
has been reported. The study also indicated that the incidence of
seizures increased with multiple catheter revisions.
Important Safety Information
The most common complications associated with this product are due
to obstruction of the system, infection, and mechanical malfunction.
Catheters may become kinked, disconnected, or blocked. It is
important to review the product labeling for complete safety
information, potential complications, contraindications, and a
complete explanation of warnings and precautions.
Shunt obstruction may occur in any of the components of the shunt
system. The ventricular catheter may become occluded by particulate
matter such as blood clots or brain fragments, by investment of the
catheter tip in choroid plexus, by embedding of the catheter in
brain tissue, or by coaptation of the ventricular walls in the
presence of overdrainage (“slit ventricles”). It is important to
review the product labeling for complete safety information,
potential complications, contraindications, and a complete
explanation of warnings and precautions.
Research shows that there is an increased risk of shunt valve
infection in younger patients, especially premature infants,
patients who have had a previous shunt infection, and patients who
have been on an external drainage system. Shunt infections are
associated with much greater morbidity for patients, as well as
increased costs to healthcare providers and society. Complications
include additional surgeries and lengthened hospital stays,
developmental disabilities and loss of IQ, and death.
Caution: Federal (USA) law restricts this device to sale by or
on the order of a physician. Refer to product package insert for
instructions, warnings, precautions and complications