Medtronic 27816 Instructions for Use

Strata® Products

PRESSURE (mm H

O)

FLOW RATE (mL/hr)

P/L 0.5 P/L 1.0 P/L 1.5 P/L 2.0 P/L 2.5

on test conditions and condition of the valve.

Strata NSC Valve Performance

Radiopaque Flow Direction Indicator

Mechanism

Mechanism

Indicator

Silicone Dome

Strata NSC Valve

PRESSURE (mm H

O)

FLOW RATE (mL/hr)

Silicone Dome

Integral Inlet Connector

Silicone Dome

to Catheter Indicator

Description

After surgical implantation, the Strata II and Strata NSC valves provide a non-invasive method to address
changing patient needs in the management of hydrocephalus. The unique valve design allows the
physician to adjust valve pressure/performance level by using the Strata II Adjustment Kit. The design helps
ensure that the valve's per formance level resists inadvertent changes.

Strata II Valve

The Strata I I valve incorporates a b all and cone pressure val ve in series with a norma lly closed siphon cont rol
mechanism (Delta® chamber). This combination enables the valve to maintain intraventricular pressure (IVP)
within a nor mal physiological r ange, regardless of a p atient’s cerebrospin al fluid (CSF) flow re quirements or
body pos ition. Flow control is accom plished by combined r esistance of the ball an d cone, and the siphon cont rol
diaphrag m. The degree of resis tance determines th e performance cha racteristics of t he valve. Retrograde flow
is prevented by the ball and co ne. The siphon ef fect is controlled by the two normally clos ed silicone elastom er
diaphrag ms of the Delta chamber. The diaphrag ms open in response to p ositive upstream IVP.

The Strata II valves, small and regular, provide a full range of Per formance Levels: 0.5, 1.0, 1.5, 2.0, and 2. 5.
Performance characteristics of the valve are shown in Figures 1 and 2 . Pressure/flow performance data with
and without siphon ef fect is indicate d. Each valve is individually tested to ensure conformance with labeled
performance characteristics.

1

Strata II Valve Performance at 0 cm H2O Distal Hydrostatic Pressure

160

140

120

2

100

80

60

40

20

2

Strata II Valve Performance at -50 cm H2O Distal Hydrostatic Pressure

160

140

120

2

100

80

60

40

20

135

105

70

35

15

5 20 30 40 50

147

120

85

50

30

5 20 30 40 50

Performance Level 2.5

Performance Level 2.0

Performance Level 1.5

Performance Level 1.0

Performance Level 0.5

Performance Level 2.5

Performance Level 2.0

Performance Level 1.5

Performance Level 1.0

Performance Level 0.5

The Strata II valves are fabricated with a precision molded firm polypropylene and acetal plastic base
invested in a smooth, flexible silicone elastomer housing with a contoured bottom (Figs 3 and 4). The base
contributes to structural integrity and pressure/flow reliability, and is designed to prevent distortion of the
valve mechanism, siphon control ports and diaphragms. The dome is marked with a radiopaque tantalum­impregnated direction arrow showing flow direction.

3

Strata II Valve Regular

Radiopaque Flow Director Indicator

Reservoir

Proximal Occluder

Integral Inlet Connector

Radiopaque Valve

4

Strata II Valve Small

Radiopaque Valve

to Catheter Indicator

Firm Plastic Base

Reservoir

Adjustable Valve Mechanism

Radiopaque Flow Director Indicator

Adjustable Valve Mechanism Firm Plastic Base

The Performance Level is discernible through use of the Strata II Adjustment Kit, the StrataVarius
Adjustment System or by X-ray (for corresponding set tings, refer to Fig5).

The Strata II valves incorporate connectors designed to decrease the possibility of catheter disconnec tion.
One encircling ligature is required to secure each catheter to the valve. Radiopaque markers at the base of
each connector (Figs 3 and 4) allow X-ray visualization of the relative positions of catheters and valve in vivo
when radiopaque catheters are used.

5

P/L 0.5 P/L 1.0 P/L 1.5 P/L 2.0 P/L 2.5

The dome is designed to allow injection or CSF sampling via a 25-gauge or smaller noncoring needle. Complete
valve penetration by t he needle is prevente d by the firm plastic b ase. The Strata II valve c an be flushed in eith er
the distal o r proximal directi on by percutaneous f inger pressure. Occ luders are located p roximal and distal to th e
central res ervoir on the Strata II v alve regular and dist al only on the small mode l to facilitate selec tive flushing.

Strata II Shunt Assemblies

Strata II shunt assemblies are made up of a valve and a pre-attached distal catheter. The connection
between the siphon control portion of the valve and the integral distal catheter allows catheter rotation.

Strata II Snap Shunt Assemblies

The Strata II Snap Shunt Assemblies are comprised of a valve and an integral snap assembly ventriculostomy
reservoir dome. The connection bet ween the siphon control portion of the valve and distal catheter allows
catheter rotation.

NOTE: Each Strata II Snap Shunt Assembly
must be use d with a Snap Shunt
Ventricular Catheter (available separately)
for a complete flow control shunt. A snap
assembly tool is available separ ately to
simplify the “snap” procedure.

The Strata II Snap Shunt Assemblies
incorporate a completely unitized “snap­together” radiopaque silicone elastomer
reservoir design. The snap shunt
assembly reservoir provides direct access
to the ventricles for injection, sampling
and drainage.

Strata NSC Valve

The Strata N SC valve incorpora tes a ball
and cone pres sure valve. Flow control i s
accomplish ed by resistance of th e ball and
cone. The de gree of resistan ce determines
the per formance charac teristics of the
valve. Retr ograde flow is pr evented by
the ball and co ne. The Strata NSC val ves,
small and re gular, provide the full ra nge of
perfo rmance levels: 0.5, 1.0, 1.5, 2 .0, and 2.5.
Perfor mance characteri stics of the valve are
shown in Figur e 6. Each valve is indiv idually
tested to ens ure conformance with l abeled
performance characteristics.

The valves are fabricated with a precision

6

240

240

210

180

O)

150

2

120

90

PRESSURE (mm H

60

30

NOTE: Levels depicted are median values. All valves perform within a tolerance range of these median

values when tested at time of manufacture as follows:
Performance level 0.5: +/- 15 mm H
Performance level 1.0, level 1.5, level 2.0, and level 2.5: +/- 25 mm H2O

Every Medtronic Neurosurgery valve is tested for its performance characteristics using a water-filled system
at the time of manufacture to assure consistent, high quality. All valves must conform to labeling
specifications in these tests. Subsequent testing of the valve may give different results depending

155

125

90

55

25

167

140

105

70

50

Distal Occluder

Performance Level 2.5

200

Performance Level 2.0

145

Performance Level 1.5

90

Performance Level 1.0

35

Performance Level 0.5

15

5 20 30 40 50

O (5 mL/hr) +/- 25 mm H2O (50 mL/hr)

2

-50 cm H2O HP*

Distal Occluder

Delta Chamber

Delta Chamber

to Catheter Indicator

FLOW RATE (mL/hr)

0 cm H2O HP*

Radiopaque Valve

to Catheter Indicator

Integral Outlet Connector

Radiopaque Valve

Integral Outlet Connector

220

220

165

110

55

35

7

Strata NSC Valve Small

Silicone Dome

Integral Inlet Connector

Radiopaque Valve to Catheter

Indicator

8

Strata NSC Valve Regular

Proximal Occluder

Integral Inlet

Connector

Radiopaque Valve to Catheter Indicator

Reservoir

Firm Plastic Base

Adjustable Valve

Reservoir

Firm Plastic Base

Distal Occluder

Integral Outlet Connector

Radiopaque Valve to Catheter

Indicator

Radiopaque Flow Direction Indicator

Adjustable Valve

Distal Occluder

Integral Outlet

Connector

Radiopaque Valve to Catheter

molded f irm polypropylene and acet al plastic base invested in a smooth, f lexible silicone elastome r housing
(Figs 7 and 8). The base contributes to struc tural integrity and pressure /flow reliabilit y, and is designe d to prevent
distortion of the valve mechanism. The dome is marked with a radiopaque tantalum-impregnated direc tion
arrow showing flow direction. The per formance level is discernible through use of the Indicator Tool or by X-ray
(for corresp onding settings, refer to Fig9). The valves incor porate connector s designed to decrease the possibility
of catheter disconnection. O ne encircling ligature is required to secure each catheter to the valve. Radiopaque
markers at the base of each connector (Figs 7 and 8) allow X-ray visualization of the relative p ositions of catheters
and valve in vivo when radiopaque c atheters are used.

9

The dome is designed to allow injection or CSF sampling via a 25-gauge or smaller noncoring needle.
Complete valve penetration by the needle is prevented by the firm plastic base. The valve can be flushed in
either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximal and
distal to the central reservoir on the valve, regular and distal only on the small model to facilitate selective
flushing.

Patient Data Survey System

Each Strata II valve and Strata NSC valve is packaged with a patient wallet card and a set of adhesive -backed
labels. One label for each shunt component can be put on the chart in the operating room, the patient ’s
clinic char t, and the patient card. The card can be carried by the patient at all times, providing a current
record of implanted devices. Be sure to record the performance level setting on the patient card during the
initial setting, and for subsequent revisions to the performance level setting.

Indications

The Strata II valves and Strata NSC valves are shunt components designed to provide continued
cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the hear t or the
peritoneal cavity. The Strata II valve and the Strata NSC valve allow the physician to non-invasively adjust
the pressure/flow performance level pre- and post-implantation without the need for radiographic
confirmation in order to address changing patient needs. Additionally, the Strata II valve minimizes the
excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may
be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be
created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient
sits, stands, or is held erect).

Contraindications

Shunting of CSF into the peritoneal cavity or other areas of the body should not be carried out if there is
infection in any areas in which the various components of the shunt system will be implanted. These include
infections of the scalp and other skin areas through which the shunt system will traverse, the meninges and
cerebral ventricles, peritoneum and intraperitoneal and retroperitoneal organs, pleura and blood stream.
CSF shunting is contraindicated if there is infec tion present in any area of the body. Additionally, shunting
into the atrium of patients with congenital heart disease or other serious cardiopulmonary abnormalities is
contraindicated.

Warnings and Precautions

The valve pressure level setting should always be verif ied following patient exposure to high magnetic
fields.

Devices known to contain magnets should be kept away from the immediate valve implant location, as
they may have an ef fect on the performance level setting of the Strata-type valve. All magnets have an
exponentially decreasing effect on the valve the further away they are located. Common environmental
levels of electromagnetic (radio frequency) radiation generated by security scanners, metal detectors,
microwave ovens, mobile telephones, high voltage lines, and transformers should not affec t the
performance level settings.

Valve function and performance level setting should be che cked in the event that the valve is subjected to
significant mechanical shock or trauma.

Use the Medtronic Neurosurgery Adjustment Kit
45806 to change the valve Performance Level setting.

The Adjustment Tool contains strong magnets. Care should be taken when using the tool near magnetically
sensitive medical implants (e.g. pacemakers and vagal nerve stimulators), electronic equipment, data
storage devices such as computer diskettes or credit cards. The Locator Tool, Indicator Tool, and Adjustment
Tool should NOT be sterilized.

Ferromagnetic substances may impede the ability of the adjustment tools to change and conf irm the
Performance Level setting.

Refer to the Instructions for Use which accompany the Strata II Adjustment Kit or the StrataVarius
Adjustment System for instructions, warnings, precautions and complications.

The appropriate product and size must be chosen for the specif ic patient’s needs, based on diagnostic tests
and physician experience. Product labeling specifies applicable product performance levels or ranges.

Lint, fingerprints, talc, other surface contaminants, or residues from latex gloves can cause foreign body or
allergic reactions.

Improper use of instruments in the handling or implantation of shunt product s may result in the cutting,
slitting or crushing of components. Such d amage may lead to loss of shunt integrity, and necessi tate

premature surgical revision of the shunt system.

Care must be taken to ensure that particulate contaminants are not introduced into shunt components
during preimplantation testing or handling. Introduction of contaminants could result in improper
performance of the shunt system. Particulate matter that enters the shunt system may result in shunt
occlusion, or may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.

In securing catheters to connec tors, the encircling ligatures should be securely, but not too tightly,
fastened, lest they eventually cut 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.

“Small” size catheters have thinner walls and lower overall strength as compared with “Standard” size
catheters. These characteristics result in a comparatively greater potential failure (fracture) rate and,
therefore, shorter life expectancy for “Small” size catheters. Physicians who implant “Small” size catheters
for cosmetic reasons must acknowledge the potentially higher rate of catheter revision and weight this
against the cosmetic benefit.

Patients with hydrocephalus shunt systems must be kept under close observation in the postoperative
period for signs and symptoms that suggest shunt malfunction. The clinical findings may indicate shunt
malfunc tion. The clinical findings may indicate shunt obstruction or overdrainage of CSF.

Shunt obstruction may occur in any of the components of the shunt system. The system may become
occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or
other debris. Catheters that contact internal body structures can become kinked or blocked at their tips
(e.g., investment of a ventricular catheter tip into the choroid plexus or of the distal catheter tip into the
greater omentum or loops of the bowel). Finally, shunt obstruction may occur due to growth of an infant or
child, or physical activities which result in disconnection of the shunt components or withdrawal of a distal
catheter from its intended drainage site.

Clotting around the atrial por tion of a catheter may lead to emboliz ation of the pulmonar y arterial tree with
resulting cor pulmonale and pulmonary hypertension.

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 ventricle”).

Disconnected shunt components may further migrate.
Shunt systems may fail due to mechanical malfunction, leading to under- or overdrainage.
Malfunc tion 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, the common symptoms are increased
tension of the anterior fontanelle, congestion of scalp veins, listlessness, drowsiness and irritability,
vomiting and nuchal rigidity. In older children and adults, the common symptoms are headaches, vomiting,
blurring of vision, nuchal rigidity, deterioration of consciousness, and various abnormal neurological
findings.

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 tissue
adhesions, it is suggested that it should not be forcibly removed. It is suggested that gentle rotation of the
catheter may help to free it. It is advised that the catheter be left in place rather than risk intraventricular
hemorrhage, which may be caused by forcible removal.

45805 or the StrataVarius Adjustment System

Subcutaneous catheter passers can break at welds or component assembly points, or due to extreme
deformation of the malleable shaft. Sudden breakage can lead to trauma of tissues or organs, and
damage to the shunt system. Instruments must be inspec ted prior to use to ensure continued integrity
and functionalit y. Disposable instruments must never be reused, or injur y to the patient and physician is
possible.

”Snap shunt “-type products may disconnect at the plastic snap junction if they are: 1) damaged prior to
connection; 2) connec ted, disconnected and reconnected; or 3) not completely connected during implant.
Occipital placement has been associated with a low rate (<0.3%) of shunt component disconnections. The
surgeon should evaluate this potential risk in determining the appropriate implant placement location.
Disconnection at the plastic snap junction may result in over- or underdrainage, and will necessitate
surgical revision to replace the plastic snap components.

Subcutaneous catheter passers can break at welds or component assembly points, or due to extreme
deformation of the malleable shaft. Sudden breakage can lead to trauma of tissues or organs, and
damage to the shunt system. Instruments must be inspec ted prior to use to ensure continued integrity
and functionalit y. Disposable instruments must never be reused, or injur y to the patient and physician is
possible.

Warnings and Precautions for Magnetic Resonance Imaging

Valv es

The Strata II valve and Strata NSC valve is considered Magnetic Resonance Conditional in accordance with
ASTM F2503.

MRI systems of up to 3.0 Tesla may be used any time af ter implantation and will not damage the
Strata II valve or Strata NSC valve mechanism, but can change the performance level setting. The
performance level setting should always be checked before and after MRI exposure.

The results of the tests performed to assess magnetic field interactions, ar tifacts, and heating, indicated
the presence of the valves evaluated should present no substantial risk to a patient undergoing an MRI
procedure using the following conditions:

• Static magnetic field of 3.0 Tesla or less

• Spatial Gradient of 720 G/cm or less

• Radio Frequency (RF) Fields with an average Specific Absorption Rate (SAR) of 3 W/kg for 15 minutes.
Using the GE 3.0T Excite® HD Magnetic Resonance Imaging System, the valve experienced a maximum
temperature change of 0.4°C over a 15-minute exposure period.
The table provides maximum signal voids (artifact sizes) for standard imaging pulse sequences at 3.0 Tesla
per ASTM F2119.

Strata II Valve and Strata NSC Valve

Pulse Sequence Plane Imaging Max. Signal Void (Artifact), cm

2

T1-SE Parallel 35.16

T1-SE Perpendicular 33.03

GRE Parallel 73.94

GRE Perpendicular 66. 55

Biological debris inside the valve may impact adjustability, and may lead to adjustment mechanism
damage i f exposed to 3.0 Tesla M RI. If dicul ty is experien ced adjusting or reading the val ve
setting, radiographic setting conrmation should be considered. The reading from the Strata
II Indic ator tool or the St rataVarius system may be reversed (180 degrees oppos ite) from the
radiographic image. In this situation, radiographic imaging should be used to determine the setting
of the val ve.

Strata II Adjustment Kit and StrataVarius Adjustment System

The Strata II Adjustment Kit and StrataVarius system are Magnetic Resonance Unsafe. Do NOT take the
Adjustment Tools or the StrataVarius system into an MRI facility as the magnets could potentially be a safety
hazard to the patient and/or user.

Proximity to MRI suite may impede the mechanism in the Indicator Tool due to the field strength of an MRI
magnet. Move out of the vicinity prior to attempting to verify a valve setting.

Instructions for Use

Setting the Performance Level Before Implantation

The physician must determine the proper initial
performance level setting for each patient and adjust
the valve accordingly prior to implantation. Strata II
and Strata NSC valve PL settings are adjusted with
the Strata II Adjustment Kit
the StrataVarius Adjustment System
Refer to the Instructions for Use, which accompany
the Adjustment Tools or the StrataVarius Adjustment
System for information regarding Performance Level
adjustments prior to implantation.

45805 (Fig10) or

45806.

10

WARNING:STRATA II VALVES AND STRATA NSC
VALVES MAY NOT BE RESTERILIZE D. IT IS ESSENTIAL
TO SET THE PR ESSURE LEVEL BEFORE IMPLANTATION
WITH THE VALVE SEALED IN ITS ST ERILE PACKAGE.

Patency Check

Valv e

Place the inlet connector of the valve into filtered, sterile isotonic saline. Depress and release the valve
dome repeatedly until fluid f lows from the outlet connector (Figs 11a and 11b). If fluid flows from the outlet
connector each time the dome is depressed, the valve is patent.

11a

Inlet

Sterile Isotonic Fluid

Shunt Assemblies

If pre-fill or patency check is desired, place the inlet connector of the valve into filtered, sterile isotonic
saline. Depress and release the valve dome repeatedly until fluid flows from the outlet catheter. To avoid
retrograde flow, occlude the valve inlet when depressing the dome. Multiple dome depressions may be
required to fill the entire shunt assembly with fluid. If fluid f lows from the outlet catheter each time the
dome is depressed, the valve is patent.

Shunts with Cardiac/Peritoneal Catheters (closed end with wall slits)

1. Observe the slit openings near the distal end. All openings should allow fluid flow and appear to open

for their entire length.

2. Gently rolling the slit opening area of the catheter between the thumb and forefinger will free the

slits if they do not appear to open completely.

3. Smooth the catheter wall with the thumb and forefinger so the slit openings are in closed position

after completion of the patenc y test.

CAUTION : DO NOT ATTEMPT TO ASPIRATE FLUID TH ROUGH THE DISTAL (OUTLE T) END. DAMAGE TO
THE VALVE MAY RESULT.

CAUTION : PARTICULATE MATTER IN SOLUTIONS USED TO TEST VALVES MAY RESULT IN IMPROPER
PRODUC T PERFORMANCE . TAKE CARE TO MAINTAIN STERILITY AND AVOID PARTICULATE
CONTAMINATION.

Snap Shunt Assemblies

1. Attach the translucent prefill

adapter to the inlet of the reservoir
dome (fig12).

2. Using the blunt needle adapter,

fill a syringe with sterile, f iltered,
isotonic saline.

3. Insert the blunt needle adapter

into the por t of the prefill adapter
and using gentle syringe pressure,
flush shunt assembly with the
saline.

4. If the saline flows out of the distal

catheter end, the shunt assembly
is patent.

Optional Preimplantation
Performance Level Test

Medtronic does not recommend
functional testing of the valve prior to
implantation, due to additional handling
and potential contamination. If testing
is considered necessary, instructions are
available upon request.

Surgical Technique

Strata II Valve and Strata NSC
Valve

Note: Remove and discard the Strata

NSC valve packaging spacer (Fig 13).
A variety of surgical techniques may be

used in placing the Strata II and Strata
NSC Valves. The valve is implanted with the flat sur face adjacent to the pericranium. Site of placement is
at the discretion of the surgeon. To reduce the possibility of post-operative valve migration (e.g., as the
result of magnetic influence due to MRI), suture the valve to adjacent tissue by passing a suture through the
polyester-fabric-reinforced flanges.

Placement of a Strata II valve will have an impact on overall shunt per formance (Fig 14). The foramen of Monro
and the tip of th e ventricular catheter are established zero level reference point s for intracranial pressure
monitoring. Placement of the Strata II valve above these reference points will result in an overall increase in th e
resistance to flow of th e shunt system, with potential underdrainage. Placement of the Strata II valve below
these reference points will result in an overall d ecrease in the resistance to flow of the shunt system, with
potential overdrainage. These factors must be taken into account for proper patient therapy.

13

Packaging
Spacer

Outlet

Pump Dome

Fluid Level

12

Reservoir Dome

Prefill

Adapter

16-gauge

Blunt

Needle

Adapter

30 cc

Syringe

14

Strata II Valve Placement

• Increase in shunt back pressure

• Increase in IVP

• Potential for underdrainage

"0" Level

• Decrease in shunt back pressure

• Decrease in IVP

• Potential for overdrainage

11b

Inlet

Outlet

Pump Dome

Fluid Level

Sterile Isotonic Fluid

Valve

CAUTION : VALVE PLACEMENT C AN HAVE SIGNIFICANT EFFECTS ON THE PE RFORMANCE OF THE

Noncoring Needle

Sterilize

SMALL CATHETER

STRATA II VALVE.

The resistance properties of the Strata II valves as indicated in the performance characteristics charts in this
product labeling are specif ied at the zero reference point.

It is suggested that the valve be placed in a surgically created loose subgaleal pocket, avoiding compression
by the overlying scalp, and not under the scalp incision. The Strata II valve should not be placed under the
skin of the neck, chest, or abdomen.

Connect valve to catheters by inserting integral connectors into catheters. The connectors should be
completely covered by catheter tubing. Secure catheters to connec tors with encircling ligatures.

Injection into the Valve

The Strata valves are designed to allow injection or CSF sampling through the dome by use of a 25- gauge or
smaller noncoring needle (Fig 15).

The needle should be inserted at an angle of approximately 30° to 45° from the scalp or base of the
valve. If the valve will be punctured several times, it is recommended that the needle be inserted at
various locations to avoid multiple punctures at a single point. The catheter tubing, occluders, and valve
mechanism should not be used as injection sites.

CAUTION : LOW TEAR STRENGTH IS A CHARACT ERISTIC OF MOST SILICONE E LASTOMER MATERIALS.
CARE MUST BE TAKEN ON INSERTION AND REMOVAL OF THE NE EDLE.

CAUTION : THE SIPHON CONTRO L PORTION OF A STR ATA II VALVE IS NOT DES IGNED TO ALLOW
NEEDLE PENETR ATION. PUN CTURE OF THE DIAPHRAGMS M AY AFFECT THE PERFORMANCE
CHARACT ERISTICS OF THE VALVE AND COMPROMISE THE SHU NT SYSTEM.

15

Strata II Strata NSC

25-gauge or Smaller Noncoring Needle

25-gauge or Smaller

Injection into the ventriculostomy reservoir of the Snap Shunt Assembly

CAUTION : LOW TEAR STRENGTH IS CHARACT ERISTIC OF MOST SILICONE E LASTOMER MATERIALS.
CARE MUST BE TAKEN ON INSERTION AND REMOVAL OF THE NE EDLE.

The dome of the ventriculostomy reservoir is designed to allow multiple punctures using a 25-gauge or
smaller noncoring tip needle. Inserting the needle at various locations to avoid repeated punc tures at a
single point on the dome is recommended.

Valve Flushing

The Strata II and Strata NSC valves can be flushed in both the proximal and distal directions by
percutaneous depression of the valve dome (Fig16). To selectively f lush the Strata II and NSC regular
valves, depress and occlude either proximal or distal occluder sections of the valve by percutaneous finger
pressure, then depress the valve dome. For the small valves, distal flushing can be achieved by depressing
the ventricular catheter tubing for occlusion.

The selective flushing will cause fluid to flow in the direc tion opposite the occluded side of the valve. If
there is noticeable resistance to compression, the catheter being flushed may be occluded.

CAUTION : SHUNT OBSTRUCTION MAY OCCUR IN ANY COMPONENT OF A S HUNT SYSTEM AND
SHOULD BE DIAGNOSED BY CLINICAL FINDINGS AND DIAGNOSTIC TESTING. VALVE FLUSHING
CHARACT ERISTICS MAY NOT BE ADEQUATE TO DIAGNOSE O CCLUSION OF CATHETER S. SEE WARNING
SECTION.

Warranty

A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser

(“Purchaser”) that Medtronic Neurosurgery's single use implantable product (“Product ”) purchased by
Purchaser, at the time of delivery to Purchaser, shall be substantially free from defects in material and
workmanship. Medtronic Neurosurgery makes no warranty (express, implied, or statutory) for Produc ts that
are modif ied (except as expressly contemplated herein) or subjected to unusual physical stress, misuse,
improper operation, neglect, improper testing, use in combination with other products or components
other than those for which the Produc ts were designed, or use in any manner or medical procedure for
which the Products are not indicated.

B. Remedy. Purchaser’s exclusive remedy and Medtronic Neurosurgery's sole liability for breach of the
foregoing warrant y shall be, at Medtronic Neurosurgery's sole option and elec tion, to replace the Product
or credit Purchaser for the net amount actually paid for any such Produc t; provided that (I) Medtronic
Neurosurgery is notified in writing within ninety (90) days af ter Purchaser’s receipt of the Produc t that such
Product failed to conform, including a detailed explanation in English of any alleged nonconformity; (II)
such Produc t is returned to Medtronic Neurosurgery within ninety (90) days after Purchaser’s receipt of the
Product F.O.B. 125 Cremona Drive, Goleta, California 93117, U.S.A. or as other wise designated by Medtronic
Neurosurgery; and (III) Medtronic Neurosurgery is reasonably satisfied that the claimed nonconformities
actually exist. E xcept as expressly provided in this paragraph, Purchaser shall not have the right to return
Products to Medtronic Neurosurgery without Medtronic Neurosurgery's prior written consent.

C. EXCLUSION OF OTHER WARRANTIES. EXCEPT FOR THE LIMITED WARRAN TY PROVIDED IN (A)
ABOVE, MEDTRONIC NEUROSURGERY GRANT S NO OTHER WARRANTI ES OR CONDITIONS , EXPRESS
OR IMPLIED, AND MAN UFACTURER SPECIFI CALLY DISCLAIMS THE IM PLIED WARRANTIES AND
CONDITI ONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC
NEUROSU RGERY NEITHER A SSUMES NOR AUTHORIZES ANY OTHER PER SON TO ASSUME ANY OTHE R
LIABILIT IES ARISING OUT OF OR IN CONN ECTION WITH THE SALE OR USE OF ANY PRODUC T.

manuals.medtronic.com
medtronic.com
[phone] FAX International
[phone] FAX USA/Canada
[phone] International
[phone] USA/Canada

Minneapolis, MN 55432 USA
710 Medtronic Parkway NE
Medtronic, Inc.

© 2018 Medtronic, Inc.

2018 -10

M972510A001 B

16

Direction of Flush

Strata II

Depress Valve

Dome

Depress

Occluder

Strata NSC

Direction of Flush

Depress Valve

Dome

Depress

Occluder

Setting the Performance Level After Implantation

Strata II and Strata NSC valve PL settings are adjusted with the Strata II Adjustment Kit
StrataVarius Adjustment System
Adjustment tools or the StrataVarius Adjustment System for information regarding Performance Level
adjustments after implantation.

CAUTION : EXCESSIVE SWELLING OR BANDAGE S MAY MAKE IT DIFFICULT TO DETER MINE A VALVE
SETTI NG. WAIT UNTIL SWELLING IS RE DUCED, OR CONFIRM W ITH RADIOGRAPHIC IMAGING. IN
ADDITION, TISSU E THICKNESS CAN MAKE IT DIFFICULT TO DETERMINE VALVE SET TING. IF THIS IS
THE CASE, CONFI RM VALVE SETTING WITH RADIOGR APHIC IMAGING .

NOTE: Suggested imaging techniques for confirmation of valve settings include: 1) Use fluoroscopy

positioning to minimize valve obliqueness and ensure the images are being captured perpendicular to
the valve; 2) If f luoroscopy has insufficient power to penetrate through the tissues, use fluoroscopy for
positioning, then transition to x-ray photographic plate imaging to collimate or “cone down” on the valve,
in order to maximize the contrast and the abilit y to visualize the valve’s radiopaque markers.

45806. Refer to the Instructions for Use which accompanies the

Peritoneal Catheter Placement

A variety of surgical techniques may be used in placing the distal catheter into the peritoneal cavit y. The site
of placement is at the discretion of the surgeon.

A subcutaneous catheter passer is available for tunneling of the distal catheter. The Subcutaneous Catheter
Passer, 38or 60cm in length, is recommended.

Snap Shunt Assembly

After the ventricular catheter has been
placed, the reservoir base may be snapped
together with the shunt assembly integral
reservoir dome. A Snap Assembly Tool
is available separately to simplif y and
expedite the snap procedure. Slip the
prongs of the tool under the reser voir base;
then, snap the dome onto the base (Fig17).
After the dome and base are snapped
together, the reservoir is placed in a 6mm
burr hole or twist drill hole.

WARNING: DO NOT DISASSEMBLE
THE RESE RVOIR AND BASE ONCE
THEY ARE S NAPPED TOGETHER.
THE RESE RVOIR AND BASE ARE
DESIGNED FOR “ONE-TIME ONLY”
SNAP ASSEMBLY. METICULOUS CARE
MUST BE TAKEN DURING ASSEMBLY
TO ASSURE COMPLETE ATTACHMENT
AND TO PREV ENT DAMAGE TO PLASTIC
COMPONENTS. DISASSEM BLY AND
REASSE MBLY, AND/OR DAMAGING OF
THE PLAS TIC COMPONENTS DURING
ASSEMBLY CAN RESULT IN UNWANTED
DISCONN ECTION OR IN LEAKAGE OF THE
ASSEMBLY.

17

Snap Assembly Tool

CSF Ventricular Catheter
Incision
Dura

Snap Shunt Assembly
(underside view)

Snap Connector

Integral
Ventriculostomy
Reservoir Dome

How Supplied

Strata Products are packaged sterile
and non-pyrogenic and are intended
for single (one- time) use only. DO NOT
RESTER ILIZE. Do not use if package has
been previously opened or damaged.
Resterilization can damage the product,
potentially leading to patient injury.
Medtronic Neurosurgery is not responsible
for the per formance of any produc t that has been resterilized.

A complete shunt requires a Ventricular Catheter, a valve and a Distal Catheter.

Patient Education

It is the responsibilit y of the physician to educate the patient and/or their representative(s) regarding CSF
shunting. This should include a description of the complications associated with implantable shunt systems,
and an explanation of potential alternative products and treatments.

Complications

Complications associated with ventriculop eritoneal 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. A patient may rarely exhibit a reaction due to sensitivit y to the implant.

In CSF shunting procedures, the most common complications are due to obstruction of the system as
described under “Warnings.” Obstruction may occur in any component of the system due to plugging by
brain fragments, blood clots, and/or tumor cell aggregates at some point along its course. Obstruction may
also occur because of separation of the system 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, or other struc ture in which the catheter is implanted. As noted previously, growth of the
infant or child may cause the distal catheter to be withdrawn from the atrium into the internal jugular vein
or from the peritoneum into tissue planes where the fluid cannot be absorbed.

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 Staphylococc us
epidermidis. Other pathogens circulating in the blood stream may colonize the shunt and, in the majority of
patients, require its removal.

In 1973, Roberts on et al. summarized th e incidence of infec tion in ventriculoperitonea l shunts reported u p to
that time. Inf ection in ventricu loperitoneal shunt ing occurred in 5 to 10% of the pat ients in most of the rep orts.

In 1993, Kestle et al. reporte d significant reductions in infection (less than 4%) with the use of antibiotic s, short
duration of surgery (surgical ex perience) and control of th e operating room environment (e.g., designate d
operatin g room, limited personnel and traff ic, covered skin surfaces). The ar ticle states that result s can also be
obtained without the use of antibiotics, but with rigorous perioperative control of the environm ent.

Using prophylactic antibiotics in shunted patients is somewhat controversial as their use may predispose
infection by more resistant organisms. Therefore, 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 been described.

CSF overdrainage may result in excessive reduction of CSF pressure and predispose the development of a
subdural hematoma or hygroma, 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
pressure reduction will cause marked depression of the anterior fontanelle, overriding of cranial bones and
may convert communicating into obstructive hydrocephalus.

The incidence of epilepsy after ventricular shunting procedures has been reported. This study also
indicated that the incidence of seizures increased with multiple catheter revisions.

Returned Goods Policy

Products must be returned in unopened packages, with manufacturer’s seals intact, to be accepted for
replacement or credit, unless returned due to a complaint of product defect or mislabeling. Determination
of a product defec t or mislabeling will be made by Medtronic Neurosurger y, which determination will be
final. Products will not be accepted for replacement or credit if they have been in the possession of the
customer for more than 90 days.

45805 or the

Burr Hole

Skull Surface

Strata® ProductS

Strata® II ValVe
Strata® II Shunt aSSemblIeS
Strata® II Snap Shunt aSSemblIeS
Strata® nSC ValVe

InStruCtIonS for uSe

Caution

Sterilization: Ethylene-Oxide Gas

Do Not Reuse

Do Not Resterilize

Package Contents

Use By

Reference Number

Lot Number

Caution: U. S. federal law restricts this device to sale by or on the order of a physician.

Manufacturer

Manufacturing Facility

Magnetic Resonance Conditional

Caution: This device contains a strong magnet. Proximity to recording tape and disks should be
avoided.

Low-Low Pressure

BARIUM-IMPREGNATED

Barium-Impregnated

Pliant

Small Catheter

Extracted

Open Here

Consult Instructions for Use

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other
countries: Strata®, Strata® NSC, Str ataVarius® and De lta®. All other trademarks, service marks, registered
trademarks or registered service marks are the property of their respective owners in the United States
and other countries.