Medtronic 200SH12 Instructions for Use

INSTRUCTIONS FOR USE

Caution:
Single Use Only
Humanitarian Use Device.
Authorized by Federal law (USA) for use in patients under 18 years of

age for the correction or reconstruction of the right ventricular outflow
tract (RVOT) in the following congenital heart malformations:

■

pulmonary stenosis

■

tetralogy of Fallot

■

truncus arteriosus

■

transposition with ventricular septal defect (VSD)

■

pulmonary atresia

In addition, the Contegra pulmonary valved conduit is indicated for the
replacement of previously implanted, but dysfunctional, pulmonary
homografts or valved conduits. The effectiveness of this device for
these uses has not been demonstrated.

Contegra

Trademarks may be registered and are the property of their respective owners.

®

Pulmonary Valved Conduit

1 Device Description

The Contegra® pulmonary valved conduit consists of a heterologous (bovine)
jugular vein with a trileaflet venous valve and a natural sinus slightly larger in
diameter than its lumen. A final sterilization step is performed using a proprietary
sterilant that contains 1% glutaraldehyde and 20% isopropyl alcohol, in which
the conduit is preserved and packaged until used. Adequate rinsing with isotonic
saline solution must be performed before implantation to reduce the
glutaraldehyde concentration. The sterilization process is certified after the
quarantine interval. The Contegra pulmonary valved conduit, Model 200S, is
supported with 2 polyester-covered, polypropylene rings located at the valve
annulus and at the level of the commissures. The Contegra

pulmonary valved

conduit, Model 200, is unsupported.
Both ring-supported and unsupported models are available in the following

sizes: 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, and 22 mm. Sizes are based on
the inside diameter of the conduit's inflow side. The outflow side of the conduit
may be larger.

Both the ring-supported and unsupported models have a minimum overall length
of 10 cm, except for the 12 mm size, which is about 7 cm long. The conduit
extensions on either side of the rings are approximately 4 cm in length (3 cm for
the 12 mm size). In the case of the unsupported model, approximately 4 cm of
jugular vein tissue is present on either side of the valve (3 cm for the 12 mm
size). These dimensions allow for adequate trimming of the conduit to fit the
patient.

2 Indications for Use

The Contegra pulmonary valved conduit is indicated for correction or
reconstruction of the right ventricular outflow tract (RVOT) in patients aged less
than 18 years with any of the following congenital heart malformations:

■

Pulmonary stenosis

■

Tetralogy of Fallot

■

Truncus arteriosus

■

Transposition with ventricular septal defect (VSD)

■

Pulmonary atresia

In addition, the conduit is indicated for the replacement of previously implanted,
but dysfunctional, pulmonary homografts or valved conduits.

3 Contraindications

None known

4 Warnings and Precautions

4.1 Warnings

This device was designed for single patient use only. Do not reuse, reprocess,
or resterilize this product. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/or create a risk of
contamination of the device, which could result in patient injury, illness, or death.

Do not resterilize the conduit by any method.

Exposure of the conduit and its container to irradiation, steam, ethylene oxide,
or other chemical sterilants will render the conduit unfit for use.

Do not use the conduit if:

■

The conduit has been dropped, damaged, or mishandled in any way

■

The Use By date has elapsed

■

All tamper strips on the glass jar-and-lid container are damaged

■

The shipping temperature indicator window has turned black

■

The serial number tag does not match the container label

■

The storage solution does not completely cover the conduit

Do not expose the conduit to solutions other than the storage and rinsing
solutions.

Do not allow the conduit to dry. Maintain conduit moisture with irrigation or
immersion during surgery.

Do not attempt to repair a damaged conduit.
Do not use cutting needles, as they may cause structural damage to the conduit.
Do not pass a catheter through the conduit, as this may damage the conduit.

4.2 Precautions

The size of the conduit is based on the inside diameter of the inflow side (end).
The outflow side (end) may be larger.

Valve competency is improved at lower pressure loads; therefore, physicians
may want to consider alternate procedures or therapies for patients exhibiting or
at risk for high pulmonary pressures.

The supported Contegra conduit, Model 200S, contains polypropylene support
rings. Coronary artery compression could potentially result if the conduit is
placed over, or in close proximity, to a coronary artery.

Glutaraldehyde may cause irritation of the eyes, nose, skin, and throat if
continued exposure occurs. Avoid prolonged exposure or breathing of the
chemical vapor. Use only with adequate ventilation. If skin contact occurs,
immediately flush the affected area with copious amounts of water for
10 to 15 minutes. If eye contact has occurred, flush the eye with water for
15 minutes and seek immediate medical attention.

5 Adverse Events

5.1 Observed Adverse Events

Contegra Pulmonary Valved Conduit Clinical Study
A prospective, nonrandomized, multi-center evaluation was conducted of

patients implanted with the Contegra pulmonary valved conduit. Three-hundred
seventy-four (374) patients consented and were implanted at 18 centers.
Cumulative follow-up for these 374 patients was 1188.6 patient-years with a
median follow-up of 3.0 years (range 0 years to 7.1 years). Adverse events,
including death, were captured throughout the postoperative period and are
summerized in Table 1 and Table 2.

Table 1. Mortality Rates Following Implant with the Contegra Pulmonary Valved Conduit

European
Companion Study
and US Study
(N=374)

All Death 32 (8.6%) 16 (1.4%) 88.3% (1.7%) 87.4% (1.9%) 86.4% (3.3%)

Not Device­Related

Device-Related or
Unexplained

Device-Related 0 (0.0%) 7 (0.6%) 98.8% (0.6%) 97.7% (0.9%) 97.7% (1.5%)

Unexplained 2 (0.5%) 1 (0.1%) 99.4% (0.4%) 99.4% (0.5%) 98.8% (1.1%)

1. ≤30 days postoperative if the patient was discharged from the hospital, or at any time after implant if the
patient was not discharged from the hospital.

2. Greater than 30 days postoperative if the patient was discharged from the hospital.

3. Calculations were based on 1135.9 late patient-years.

4. Kaplan-Meier method was used to estimate survival, and Peto’s formula was used for the calculation of
the standard errors of these estimates.

Table 2. Morbidity Rates Following Implant with the Contegra Pulmonary Valved Conduit

European
Companion Study
and US Study
(N=374)

Endocarditis 1 (0.3%) 13 (1.1%) 98.5% (0.7%) 97.8% (0.9%) 93.7% (2.5%)

Hemolysis 9 (2.4%) 12 (1.0%) 95.4% (1.2%) 95.4% (1.3%) 94.1% (2.5%)

All Hemorrhage

Minor Hemorrhage 17 (4.0%) 24 (2.1%) 94.6% (1.3%) 94.3% (1.4%) 92.0% (2.9%)

Major Henorrhage 66 (11.8%) 7 (0.6%) 86.6% (2.0%) 86.6% (2.1%) 86.6% (3.6%)

Nonstructural
Dysfuntion

Structural
Deterioration

6

Thrombus

Reoperation

Catheter
Intervention

7

Explant 1 (0.3%) 51 (4.4%) 96.3% (1.1%) 91.7% (1.6%) 80.7% (3.7%)

Repair 2 (0.5%) 14 (1.2%) 96.6% (1.0%) 95.9% (1.2%) 94.3% (2.5%)

8

Early

Events1

n (% of

patie nts)

30 (8.0%) 8 (0.7%) 89.9% (1.6%) 89.9% (1.8%) 89.5% (3.0%)

2 (0.5%) 8 (0.7%) 98.2% (0.8%) 97.2% (1.0%) 96.6% (1.9%)

Early
Events
n (% of

patie nts)

5

83 (15.5%) 31 (2.7%) 82.2% (2.2%) 81.8% (2.4%) 80.4% (4.2%)

3 (0.8%) 49 (4.2%) 95.0% (1.3%) 92.5% (1.6%) 83.5% (3.9%)

0 (0.0%) 7 (0.6%) 99.7% (0.3%) 99.3% (0.5%) 98.0% (1.4%)

9 (2.1%) 14 (1.2%) 94.4% (1.3%) 93.4% (1.5%) 93.4% (2.5%)

3 (0.5%) 65 (5.6%) 93.3% (1.4%) 88.7% (1.9%) 76.0% (4.1%)

2 (0.3%) 116 (10.0%) 86.5% (2.0%) 80.6% (2.4%) 70.2% (4.5%)

Events2

n (% patient-

1

(% / patient-

Late

year)

Late

Events

year

3

2

n

3

)

Freedom

From4 Death

at 1

Year (SE)

Freedom

4

From

Event

at 1

Year (SE)

Freedom

From4 Death

at 2

Years (SE)

Freedom

From4 Event

at 2

Years (S E)

Instructions for Use English 1

Freedom

From4 Death

at 5

Years (S E)

Freedom

From4 Event

at 5

Years (SE)

Table 2. Morbidity Rates Following Implant with the Contegra Pulmonary Valved Conduit

European
Companion Study
and US Study
(N=374)

Device-Related 2 (0.3%) 60 (5.2%) 95.0% (1.3%) 91.1% (1.7%) 83.7% (3.8%)

Not Device-Related 0 (0.0%) 56 (4.8%) 91.5% (1.6%) 89.4% (1.9%) 85.0% (3.5%)

1. ≤30 days postoperative.

2. Greater than 30 days postoperative.

3. Calculations were based on 1159.7 late patient-years.

4. Kaplan-Meier method was used to estimate survival, and Peto's formula was used for the calculation of
the standard errors of these estimates.

5. Seven patients had 2 early major hemorrhages, 1 patient had 3 early minor hemorrhages, 1 patient had
1 early major and 1 early minor hemorrhage, 3 patients had 3 early major hemorrhages, 1 patient had
4 early major hemorrhages, and 1 patient had 7 early major hemorrhages.

6. One patient had 2 early thromboses.

7. One patient had an early repair and an early explant.

8. One patient had 2 early catheter interventions.

Early
Events
n (% of

patie nts)

1

(% / patient-

Late

Events2 n

year3)

Freedom

From4 Event

at 1

Year (SE)

Freedom

From4 Event

at 2

Years (S E)

Freedom

From4 Event

at 5

Years (S E)

5.2 Potential Adverse Events

Prosthetic heart valves have been associated with serious complications,
sometimes leading to reoperation and/or death. In addition, complications
caused by immunogenic response to the conduit or to physical, chemical, or
biological changes, may occur at undetermined intervals and may require
reoperation and replacement of the conduit. As this conduit is indicated for
patients under 18 years of age, reoperation and replacement of the Contegra
pulmonary valved conduit may be indicated because of the patient’s physical
growth.

General complications reported with valved conduits and biological tissue valves
implanted in the heart include:

■

Endocarditis

■

Hemolysis

■

Hemorrhage (including anticoagulant-related hemorrhage)

■

Immunologic rejection

■

Prosthesis calcification (intrinsic and extrinsic)

■

Prosthesis (conduit) dilatation

■

Prosthesis (conduit) dissection

■

Prosthesis nonstructural dysfunction (for example, neointimal thickening or
neointimal peeling/dehiscence)

■

Prosthesis regurgitation

■

Prosthesis structural deterioration (perforation, tear, thickening, dissection,
or myxomatous degeneration)

■

Prosthesis stenosis

■

Prosthesis thrombosis

■

Pulmonary hypertension

■

Thromboembolism

■

Residual or increasing transvalvular pressure gradient

■

Obstruction of implant

■

Pulmonary embolism

■

Coronary artery compression

It is possible that these complications could lead to:

■

Reoperation

■

Explantation

■

Permanent disability

■

Death

These complications may present clinically with abnormal heart murmur,
shortness of breath, exercise intolerance, dyspnea, orthopnea, anemia,
fever, arrhythmia, hemorrhage, low cardiac output, pulmonary edema,
myocardial infarction, hemolytic anemia, and congestive heart failure.

6 Instructions for Use

The function of a pulmonary valved conduit is sensitive to surgical implantation
techniques. Physicians performing the implantation must be familiar with the
techniques for implanting a pulmonary homograft or valved conduit.

The Contegra pulmonary valved conduit is packaged sterile in a hermetically
sealed jar. Before opening, carefully examine the jar and lid for damage,
leakage, or broken seals. The jar should contain enough sterilant to cover the
conduit.

Caution: Rinse the conduit continuously for a minimum of 15 minutes to
reduce the glutaraldehyde concentration from the conduit. Aseptic

technique must be used in the following steps:

1. Prepare 4 sterile bowls, 3 of which contain isotonic saline solution (500 mL)
for rinsing.

2 English Instructions for Use

2. Remove the conduit by grasping the serial number tag with atraumatic
forceps and lifting it from the jar. The serial number tag is sutured to the
outflow end of the conduit. Verify that the serial number tag matches the jar
label. If any difference is noted, the conduit should not be used. This tag
should not be detached from the conduit until implantation is imminent.

Note: The outside of the jar is not sterile.

3. Drain the residual storage solution from the conduit into the empty Discard
Bowl (Bowl 1) by holding the conduit (with fingers) with the serial tag
(outflow) downward and inflow end upward.

Note: The slightly larger central portion of the conduit, the sinus, contains
the valve. Do not handle the sinus area.

4. Gently squeeze (with fingers) the conduit below the sinus to eliminate most
of the sterilant solution.

5. Transfer the conduit to the First Rinse Bowl (Bowl 2). Immerse and gently
squeeze (with fingers) above and below the sinus area. Fill the conduit with
rinse solution and empty by tilting the serial number tag (outflow) downward,
and inflow end upward with fingers. Alternately swirl, gently squeeze, empty,
and fill the conduit for 5 minutes. Remove all solution from the conduit
before transferring.

6. Transfer the conduit to the Second Rinse Bowl (Bowl 3) and repeat step 4
for a minimum of 5 minutes.

7. Transfer the conduit to the Third Rinse Bowl (Bowl 4). Continue rinsing for
a minimum of 5 minutes using the same technique described for Bowls 2
and 3. Leave the conduit in the Third Rinse Bowl until needed for
implantation to prevent the tissue from drying.

8. Empty the rinse solution from the conduit before handing the device into the
surgical field. The surgeon or assistant will remove the serial number tag
and attaching suture.

7 Surgical Procedure

Cardiac surgical procedures can be complex and subject to variability. The
Contegra
competency is improved at lower pressure loads; therefore, physicians may
want to consider alternate procedures or therapies for patients exhibiting, or at
risk for, high pulmonary pressures. These factors suggest that the choice of
surgical technique must be left to the discretion of the individual surgeon,
observing the Warnings and Instructions for Use described herein.

Surgical Precautions: The conduit should be handled carefully and gently.
Examine the conduit, and note the direction of the arrow. The arrow denotes the
direction of flow.

Note: The arrow does not indicate location of the valve. If the conduit is
dropped, damaged by cutting, or in any way mishandled, it must not be used
for human implantation.

During implantation, the conduit must be kept moist with isotonic saline solution
until circulation is restored.

®

pulmonary valved conduit may be used for several indications. Valve

8 Clinical Study

Contegra Pulmonary Valved Conduit Clinical Study
A prospective, nonrandomized, multi-center evaluation was conducted of

patients implanted with the Contegra pulmonary valved conduit. Three-hundred
seventy-four (374) patients consented and were implanted at 18 centers.
Cumulative follow-up for these 374 patients was 1188.6 patient years with a
median follow-up of 3.0 years (range 0 years to 7.1 years). Preoperative data,
safety, effectiveness, and comparative literature data are presented in the tables
below.

Table 3. Preoperative Data (N=374)

Variable Category n %

Age at Implant Less than 3 months 73 19.5

3 to 12 months 64 17.1

13 to 24 months 62 16.6

25 months to 5 years 77 20.6

6 to 10 years 48 12.8

Greater than 10 years 50 13.4

Gender Male 219 58.6

Female 155 41.4

1

Cardiovascular Presentaion

Pulmonary Stenosis 173 46.3

Tetralogy of Fallot 139 37.2

Pulmonary Insufficiency 125 33.4

Pulmonary Atresia 121 32.4

Truncus Arteriosus 101 27.0

Failed Repair 82 21.9

Failed Homograft 79 21.1

Congestive Heart Failure 66 17.6

Pulmonary Hypertension 58 15.5

Failed Composite Conduit 43 11.5

Double Outlet 45 12.0

Table 3. Preoperative Data (N=374) 7. at last follow-up, median=28.5 months

Transposition of Great Arteries 33 8.8

Systemic Hypertension 8 2.1

Bacterial Endocarditis 5 1.3

Ross Procedure 2 0.5

Rheumatic Etiology 0 0.0

1. Patients may have more than 1 cardiovascular presentation.

Table 4. Risk Factors Associated with Time to Death (All Causes) (n=374)

Risk Factor Relative Risk 95% Confidence Interval P-Value

Age at Implant

Less than 3 months 2.87 1.60- 5.12 0.0004

Concomitant Procedure

Any 6.34 1.91 - 20.99 0.003

Cox Proportional Hazards Survival regression analysis was used to assess the association of risk factors
and time to event.

Table 5. Risk Factors Associated with Time to Reoperation (n=374)

Risk Factor Relative Risk 95% Confidence Interval P-Value

Cardiovascular Presentation

Tetralogy of Fallot 2.06 1.26 - 3.37 0.004

Val v e S i ze

12 mm or 14 mm 2.82 1.70 - 4.68 <0.0001

Cox Proportional Hazards Survival regression analysis was used to assess the association of risk factors
and time to event.

Table 6. Risk Factors Associated with Time to Explant (n=374)

Risk Factor Relative Risk 95% Confidence Interval P-Value

Age at Implant

Less Than 1 Year 3.18 1.84 - 5.51 <0.0001

Cardiovascular Presentation

Tetrology of Fallot 3.12 1.78 - 5.49 <0.0001

Cox Proportional Hazards Survival regression analysis was used to assess the association of risk factors
and time to event.

Table 7. Comparative Literature (Homograft vs. Contegra Pulmonary Valved Conduit)

Author/yr #

Medtronic,
Contegra 2006

Albert, 1993 115 3.5y (6d-17y) 16 80

Baskett, 1996 44 6.2y1 (3d-20y) 7 93

Baskett, 2003

Bielefield, 2001 223 2.8y (5d-17y) 14 84

Boethig, 2005 52 1.5y1 (6d-6y) 15 85

Chan, 1994 41 3.1y1 (3m-

Christenson,
2004

Daenen, 1997 187 25y (7d-20+y) 1 96 88819

Dittrich, 2000 23 1.9y (5d-9y) 13

Hopkins, 1996 98 10 90

Lamberti, 1991 60 2.9y (15d-22y) 3 96

LeBlanc, 1998 76 3.1y (6d-19y) 5 93 96

Levine, 2001 17 16d (1d-92d) 24 100

Perron, 1999 84 26d (1d-3m) 11 81 91 20

Salim, 1995 43 4.7y (0.2-21y) 19 98

Schorn, 1997 63 1.3y (±0.9y) 27 92 13

Sinzobahamvya,
2001

Sinzobahamvya,
2007

Stark, 1998 405 6.8y (--) 97

Tam, 1995 56 3.6y1 (1d-24y) 16 84

Tweddell, 2000 205 6.9y (3d-48y) 11 89

Yankah, 1995 53 -- (1m-24m) 28 71 94 28

1. median

2. device-related catheter interventions

3. at 1 year

4. estimated from graph in article

5. time of evaluation not indicated

6. same population as Baskett, 1996

Mean age (SD

pts

or range)

d=day

m=month

y=year

374 2.0y1 (1d-19y)

6

83 3.0y1 (1d-19y) 6 95

28y)

59 6.4y (1m-14y) 0 100 96

76 46d1 (2d-1.1y) 9 87 13

13 198d (10d-

371d)

Death (%) Freedom

Early Freedom

From @

988 93 11

877100

1 yr

From
reop @
1 yr (%)

4

4

4

4

4

4

4

4

98

4

95

4

4

97

4

90

4

93 4 20515

4

100 39936

95

Catheter

Intervention-

% of pts

having a cath

interv. %

2

10 43735

3

Regurgitation

#

≥ mod

valves

regurg

eval.

(%)

3

246

20

5

29

38

90553

8. at last follow-up, mean=34 months

9. at last follow-up, median=8 .6 years
shaded cells: no data available

Since literature data could not be found, note that the morbidity rates of the
Contegra pulmonary valved conduit could not be compared with those of the
control for the following complications: hemolysis and thrombosis.

The effectiveness parameters that were collected included peak gradient, mean
gradient, and regurgitation data. The data were sufficient to provide reasonable
assurances of the probable benefit of the Contegra pulmonary valved conduit.

The clinical experience to date was limited in the following areas:

■

Patients above the age of 4 years at implant accounted for 34% of the total
patient population.

■

Model 200S was used in 14.7% of the total implants.

■

Orthotopic placement was 25.1% of the total implants.

9 Individualization of Treatment

9.1 Specific Patient Populations

The safety and probable benefit of the Contegra pulmonary valved conduit has
not been established for the following specific populations because it has not
been studied in these populations:

■

Patients who are pregnant

■

Nursing mothers

■

Patients with abnormal calcium metabolism (eg, chronic renal failure,
hyperparathyroidism)

■

Patients with aneurysmal aortic degenerative conditions (eg, cystic medial
necrosis, Marfan’s Syndrome)

In addition, the clinical data provided to support the safety and probable benefit
of the Contegra pulmonary valved conduit were limited in some areas, as
identified in the Clinical Study section.

10 Patient Counseling Information

Patients may require anticoagulation and/or antiplatelet therapy for an indefinite
period based on each patient's condition.

Patients with bioprostheses are at risk for bacteremia (for example, undergoing
dental procedures) and should be advised about prophylactic antibiotic therapy.

Patients should be encouraged to carry the Implanted Device Identification
Card, provided by Medtronic, with them at all times.

11 How Supplied

11.1 Packaging

The Contegra pulmonary valved conduit is provided sterile and nonpyrogenic
in a sealed container made of glass and a screw cap with a gasket.

Sterility is compromised if the glass jar-and-lid container is opened and/or
damaged. The outside of the container is nonsterile and should not be placed in
the sterile field.

11.2 Sto rag e

The Contegra pulmonary valved conduit must be stored between 15°C and 25°C
(59°F and 77°F). Refrigeration is not required, and freezing may damage the
device. Room temperature storage up to 25°C (77°F) is satisfactory provided the
device is not exposed to sunlight or other ultraviolet light sources or placed
where significant temperature fluctuations may occur.

Appropriate inventory control should be maintained so that devices with earlier
Use By dates are preferentially implanted and expiration is avoided.

11.3 Return of Explanted Devices

Medtronic is interested in obtaining recovered Contegra pulmonary valved
conduits. When determined to be appropriate, explants will be studied by a
consulting pathologist. A written report summarizing the findings will be returned

to the physician. Product return kits, including an explant information form, are
available by contacting Medtronic distribution centers or a Medtronic sales
representative. It is important that the explant form be completely filled out. If a
kit is not available, place the explanted bioprosthesis in a container of
glutaraldehyde or 10% buffered formalin immediately after excision. For further
instructions on the return of an explanted device, contact a Medtronic sales
representative.

12 Patient Information

Note: Patient registration does not apply in countries where patient privacy laws

conflict with providing patient information, including countries from the EU.
A patient registration form is included in each package. After implantation,

please complete all requested information. The serial number is located on both
the package and the identification tag attached to the conduit. Return the original
form to the Medtronic address indicated on the form, and provide the temporary
identification card to the patient prior to discharge.

Instructions for Use English 3

An Implanted Device Identification Card is provided to the patient. The card
contains the name and telephone number of the patient’s physician as well as
information that medical personnel would require in an emergency.

Medtronic has made available a patient information booklet that the physician
may provide to the patient. Copies of this booklet are available on request from
a Medtronic sales representative.

13 Postoperative Information

13.1 Magnetic Resonance Imaging (MRI) Compatibility

The Contegra pulmonary valved conduit, Model 200 and 200S, is Magnetic
Resonance (MR) safe. The Contegra pulmonary valved conduit contains no
metal and, therefore, poses no known hazards in all MR environments.

The device will not cause any harm to the patient when exposed to MR scanning
immediately after implantation. MRI at 3.0 T and 1.5 T may be performed
immediately following the implantation of the device.

13.2 Image Artifact

MR image quality may be compromised if the area of interest is in the same
area, or relatively close to the position of the device. It may be necessary to
optimize MR imaging parameters for the presence of this implant.

14 Disclaimer of Warranty

THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED
STATES CUSTOMERS ONLY:

ALTHOUGH THE CONTEGRA PULMONARY VALVED CONDUIT, MODELS 200 AND 200S,
HEREAFTER REFERRED TO AS “PRODUCT”, HAVE BEEN MANUFACTURED UNDER
CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS
ALL WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO ANY PERSON
OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES CAUSED BY ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT,
WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT, OR
OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY
REPRESENTATION OR WARRANTY WITH RESPECT TO THE PRODUCT.

The exclusions and limitations set out above are not intended to, and should not
be construed so as to, contravene mandatory provisions of applicable law. If any
part or term of this DISCLAIMER OF WARRANTY is held by any court of
competent jurisdiction to be illegal, unenforceable, or in conflict with applicable
law, the validity of the remaining portion of the DISCLAIMER OF WARRANTY
shall not be affected, and all rights and obligations shall be construed and
enforced as if this DISCLAIMER OF WARRANTY did not contain the particular
part or term held to be invalid.

Explanation of symbols on package labeling

Refer to the device labeling to see which symbols apply to this product.

Use By

Quantity

Manufactured In

Do Not Use if Indicator Turns Black

Manufacturer

Manufacturer:
Medtronic, Inc.

710 Medtronic Parkway
Minneapolis, MN 55432
USA
Internet: www.medtronic.com or
www.heartvalves.com
Tel. [phone]
Fax [phone]
Toll-Free:
1-877-526-7890
(24-hour consultation service)

Manufactured In:

Medtronic Heart Valves Division
1851 E. Deere Avenue
Santa Ana, CA 92705 USA

© 2007, 2008, 2013, 2015 Medtronic, Inc.
M057066T001 Rev. 1A

*M057066T001*

Sterile LC: Device has been sterilized using Liquid Chemical Sterilants according
to EN/ISO 14160.

Temperature Limit

Size

Serial Number

Model

For US Audiences Only

Do Not Reuse

Consult Instructions for Use

Catalog Number

MR Safe

Do Not Use if Package is Damaged

Do Not Resterilize

Nonpyrogenic

4 English Instructions for Use