Medtronic Open Pivot™
Aortic Valved Graft
502
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
Trademarks may be registered and are the property of their respective owners.
Explanation of symbols on package labeling
Refer to the device labeling to see which symbols apply to this product
Nonpyrogenic
Sterilized Using Irradiation
Size
Do Not Reuse
Do Not Resterilize
Use-By Date
Quantity
Open Here
Consult Instructions for Use
For US Audiences Only
Keep Dry
Upper Limit of Temperature
Date of Manufacture
Serial Number
Catalog Number
Manufacturer
Authorized Representative in the European Community
MR Conditional
Do Not Use if Package is Damaged
Manufactured In
1
2
8
9
10
4
3
1
5
6
7
1. Outer lid
2. Valve
3. Inner container
4. Valve graft
5. Tape
6. Rotator
7. End cap
8. Leaflet actuator pouch
9. Green leaflet actuator
10. Outer tray
Figure 1. Double barrier package
2
2
1
1. Graft release suture
2. Radial ridge
Figure 2. AVG and handle rotator assembly
3
1
1. Leaflet actuator
4
Figure 3. Sizer set and leaflet actuator
Aortic Valved Graft
1. Device Description
The Medtronic Open Pivot™ aortic valved graft (AVG), Model 502, combines the aortic Medtronic Open
Pivot™ heart valve with the Hemashield™ woven double velour vascular graft. The aortic valve orifice and
leaflets are constructed of pyrolytic carbon. The sewing cuff is constructed of titanium and polyester fabric.
The Hemashield woven double velour vascular graft is a woven, double velour, polyester graft
impregnated with highly purified collagen. The AVG is available in the dimensions and sizes shown
in Table 1.
Table 1. Medtronic Open Pivot Aortic Valved Graft Dimensions
Size (mm)
21 502AG21 10.3 16.8 21.5 2.02 24
23 502AG23 11.3 18.8 23.5 2.56 26
25 502AG25 12.3 20.8 25.5 3.17 28
27 502AG27 13.3 22.8 27.5 3.84 30
29 502AG29 14.3 24.8 29.5 4.59 32
1.1. Aortic Valve
The prosthesis consists of an orifice housing 2 mirror image leaflets. The low profile of the prosthesis
results from the bileaflet design. The pivot areas are located entirely within the orifice ring, which
minimizes the overall height of the valve. Pivot guides located on the inner circumference of the orifice ring
control the maximum range of leaflet motion. The pivot geometry consists of arc-shaped notches at either
end of each leaflet and semispherical protrusions at 4 places on the orifice. Each leaflet rotates around
2 opposing semispheres. There are inflow and outflow stops adjacent to each sphere on the orifice. The
inflow and outflow stops limit the rotation of the leaflets. There are no recesses or cavities in the pivot
area. The leaflets open to an approximate angle of 85 degrees and close to a maximum angle of
approximately 25 degrees.
The leaflets consist of pyrolytic carbon, coated over a graphite substrate. The graphite substrate is
impregnated with 20% tungsten for radiopacity. The orifice consists entirely of pyrolytic carbon.
The valve sewing cuff is constructed of double velour polyester fabric mounted on the orifice using a
titanium stiffening ring and secured with 2 titanium lock rings and a titanium lock wire. This method of
sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during surgical placement.
1.2. Vascular Graft
The Hemashield woven double velour vascular graft is a woven, double velour polyester graft impregnated
with highly purified collagen. The Hemashield woven double velour vascular graft minimizes bleeding at
implant and eliminates the operative preclotting step, including cumbersome autoclave techniques. The
collagen is gradually resorbed by the patient.
The vascular graft uses the Contcentricrimp pleat and GUIDELINE™ stripe. In addition to collagen, the
graft also contains glycerol as a softening agent.
Model Number
Overall
Valve Profile
Height (mm)
Valve Inside
Diameter
(mm)
Tissue
Annulus
Diameter
(mm)
Valve Orifice
Area (cm2)
Conduit
Inside Diameter (mm)
2. Indications for Use
The AVG is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic
aortic valves, where a replacement valve and replacement or repair of the aorta is required.
3. Contraindications
The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. The Hemashield woven
double velour vascular graft is not approved for use as a coronary artery replacement.
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 use the AVG if the prosthesis has been dropped, damaged, or mishandled in any way. Should
the valve be damaged during implantation or removal from the package, do not use for implantation.
■
Do not use the AVG if the tamper-evident seal is broken or the Use-By Date has elapsed.
■
Do not pass a catheter through the prosthesis as this may cause valvular insufficiency, leaflet
dislodgment, or catheter entrapment.
■
Do not apply force to the leaflets, attempt to change the position of the leaflets, or remove a leaflet.
■
Do not preclot. With the Hemashield woven double velour vascular graft treatment, no preclotting is
required.
■
The graft should not be implanted in patients with a known sensitivity to products of bovine origin.
■
Do not expose to temperatures greater than 50°C (122°F).
■
Do not use device if conduit appears wet.
4.2. Precautions Prior to Use
■
Avoid damaging the prosthesis. Only handle the prosthesis with the accessories provided by
Medtronic. Touching the valve with gloved fingers or any surgical instrument may cause damage to the
Instructions for Use English 5
valve surface that cannot be seen with the unaided eye. Such damage may serve as a nidus for
thrombus formation. The damage may also lead to leaflet escape or accelerated structural
deterioration of the valve.
■
Store in a cool, dry location.
4.3. Precautions During Use
■
Use only the Medtronic Open Pivot™ heart valve sizer to select the proper prosthesis size as other
sizers may result in improper selection.
■
When seating the valve, ensure that no suture material or anatomic structures interfere with leaflet
motion. Rotate the valve to avoid abnormal residual pathology that could interfere with leaflet motion.
■
If surgical technique requires crossclamping of the graft, use atraumatic clamps.
■
Use only taper point needles for suturing the graft as taper cut or other cutting needles may cut the
graft fibers.
■
Avoid excessive tension on the prosthesis. Gently extend the graft until the crimps are flat.
■
If the AVG conduit material needs to be cut, use a cautery to prevent unraveling. Use of a hightemperature cautery may cause ignition of dry graft material. To minimize this potential, the graft
material may be moistened and kept moist.
■
Fibrin glue may be used to seal the cuff suture line and the coronary anastomosis.
5. Adverse Events
A total of 965 Medtronic Open Pivot heart valves were implanted in 965 patients at 20 centers. The mean
follow-up was 1.4 years (range 0 to 5 years) with a total of 1323 patient-years. A total of 56 deaths
occurred during the study and 20 of these were characterized as valve related. The causes of valverelated deaths were endocarditis (2 patients), paravalvular leak (1 patient), thromboembolism (3 patients),
anticoagulant-related hemorrhage (10 patients), and unknown (4 patients).
5.1. Observed Adverse Events
Table 2 shows the observed adverse events for early events (occurring ≤30 days postimplant), the
linearized rates for late events (occurring >30 days postoperatively ), and the actuarial freedom from
adverse event rates at 1 and 5 years postoperatively.
Table 2. Observed Adverse Events
Events Late Events Actuarial Freedom by Kaplan-Meier
Early
Aortic Valve Replacement, All patients implanted: N=685, Cumulative Follow-up=866.4 patient years
Deaths (all causes) 2.04% (14) 2.77% ± 1.06%
Death (valve-related/unexplained)
Anticoagulant-Related Hemorrhage (All)
Anticoagulant-Related Hemorrhage
(Major)
Thromboembolism
(All)
Permanent Neurological Events
Transient Neuro-
logical Events
Valve Thrombosis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
Perivalvular Leak
(All)
Perivalvular Leak
(Major)
Endocarditis 0.00% (0) 0.35% ± 0.46% (3) .9960 [± .01] .9908 [± .01]
Hemolysis 0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
Structural Dysfunc-
tion
Nonstructural Dys-
function
Reoperation 0.15% (1) 0.35% ± 0.46% (3) .9961 [± .01] .9914 [± .01]
Explant 0.00% (0) 0.23% ± 0.41% (2) .9978 [± .00] .9931 [± .01]
Mitral Valve Replacement, All patients implanted: N=280, Cumulative Follow-up=374.7 patient years
Deaths (all causes) 1.79% (5) 3.47% ± 1.88%
Death (valve-rela-
ted/unexplained)
Anticoagulant-Rela-
ted Hemorrhage (All)
% of pts (N) %/pt-yr (N) 1 Year [95% CI] 5 Years [95% CI]
0.58% (4) 1.15% ± 0.74%
(24)
(10)
4.67% (32) 1.96% ± 0.91%
(17)
3.21% (22) 1.27% ± 0.76%
(11)
1.75% (12) 2.08% ± 0.93%
(18)
0.88% (6) 0.69% ± 0.60% (6) .9920 [± .01] .9706 [± .04]
0.88% (6) 1.39% ± 0.78%
(12)
0.15% (1) 0.46% ± 0.52% (4) .9966 [± .00] .9898 [± .01]
0.15% (1) 0.12% ± 0.33% (1) .9983 [± .00] .9983 [± .00]
0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
(13)
0.71% (2) 1.07% ± 1.19% (4) .9831 [± .02] .9342 [± .07]
3.21% (9) 0.53% ± 0.95% (2) .9958 [± .01] .9673 [± .06]
.9735 [± .01] .9031 [± .05]
.9817 [± .01] .9539 [± .03]
.9781 [± .01] .9340 [± .04]
.9878 [± .01] .9473 [± .04]
.9733 [± .01] .9283 [± .05]
.9812 [± .01] .9564 [± .03]
.9814 [± .02] .8099 [± .11]
6 Instructions for Use English
Early Events Late Events Actuarial Freedom by Kaplan-Meier
Anticoagulant-Related Hemorrhage
(Major)
Thromboembolism
(All)
Permanent Neurological Events
Transient Neuro-
logical Events
Valve Thrombosis 0.00% (0) 0.53% ± 0.95% (2) .9947 [± .01] .9866 [± .02]
Perivalvular Leak
(All)
Perivalvular Leak
(Major)
Endocarditis 0.36% (1) 0.53% ± 0.95% (2) .9957 [± .01] .9861 [± .02]
Hemolysis 0.00% (0) 0.53% ± 0.95% (2) .9952 [± .01] .9814 [± .03]
Structural Dysfunc-
tion
Nonstructural Dys-
function
Reoperation 0.71% (2) 1.07% ± 1.19% (4) .9874 [± .01] .9697 [± .03]
Explant 0.36% (1) 0.53% ± 0.95% (2) .9959 [± .01] .9783 [± .03]
Notes:
1. Cumulative probability of freedom from event estimate at the end of the interval (Pc) is based on the
Kaplan-Meier method.
2. The 95% confidence interval bound for the cumulative freedom rate at the end of the
interval = 1.96 X SE, where SE is the standard error estimate of the cumulative probability of freedom
from a heart valve related or an unexplained event estimate calculated using Greenwood’s formula.
3. The actuarial hazard rate estimates are calculated at the midpoint of each interval.
4. The 95% confidence interval bound for the hazard rate at the midpoint of each interval = 1.96 X SE,
where SE is the standard error estimate of the hazard rate estimate at the midpoint of the interval.
5.2. Potential Adverse Events
Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not
limited to:
■
angina
■
cardiac arrhythmia
■
endocarditis
■
hemolysis
■
hemolytic anemia
■
hemorrhage, anticoagulation-related
■
myocardial infarction
■
leaflet entrapment (impingement)
■
nonstructural dysfunction
■
pannus
■
perivalvular leak
■
transvalvular regurgitation
■
structural dysfunction
■
thrombosis
■
stroke
■
thromboembolism
Adverse events potentially associated with the use of vascular grafts include, but are not limited to:
■
aneurysm
■
collagen has been shown to be a weak immunogen; clinical reactions to collagen implantation have
been described as infrequent, mild, localized, and self limiting
■
embolism
■
hemorrhage
■
infection
■
occlusion (including thrombosis and anastomotic intimal hyperplasia)
■
pseudoaneurysm
■
seroma
It is possible that these complications could lead to:
■
reoperation
■
explantation
■
permanent disability
% of pts (N) %/pt-yr (N) 1 Year [95% CI] 5 Years [95% CI]
3.21% (9) 0.53% ± 0.95% (2) .9958 [± .01] .9673 [± .06]
3.21% (9) 4.00% ± 2.00%
(15)
1.79% (5) 0.80% ± 1.08% (3) .9910 [± .01] .9807 [± .02]
1.43% (4) 3.20% ± 1.82%
(12)
0.71% (2) 1.07% ± 1.19% (4) .9819 [± .02] .9819 [± .02]
0.36% (1) 0.53% ± 0.95% (2) .9915 [± .01] .9915 [± .01]
0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
0.00% (0) 0.00% ± 0.00% (0) 1.000 [± .00] 1.000 [± .00]
.9534 [± .03] .8589 [± .09]
.9621 [± .03] .8758 [± .09]
Instructions for Use English 7
■
heart failure
■
death
6. Instructions for Use
6.1. Physician Training
No special training is required to implant the AVG. The techniques for implanting this AVG are similar to
those used for any aortic valved graft.
6.2. Handling and Preparation Instructions
Proper prosthesis size selection is an important part of heart valve replacement. The size of the Medtronic
Open Pivot heart valve is determined using a Medtronic Open Pivot heart valve sizer.
Caution: The accessories (sizers) should not be used unless cleaned and sterilized as recommended in
the Medtronic Open Pivot™ heart valve accessories Instructions for Use.
The AVG, handle rotator, and leaflet actuator are supplied sterile in the same package. The contents of
the package should be handled in an aseptic manner to prevent contamination.
Circulating Nurse:
1. Remove the double barrier containers from the shipping box, along with the Patient Registration Form.
2. Verify that the device size and serial numbers located on the tray label match the information on the
shipping box label.
3. Hold the outer tray and gently peel back the lid using sterile technique until the lid has been
completely removed from the tray.
4. Record the serial number of the AVG in the patient’s record using the stickers provided on the Patient
Registration Form.
5. Present the inner container to the scrub nurse or surgeon. Hold onto the outer tray bottom, keeping
fingers and hand below the top lip of the tray.
Scrub Nurse/Surgeon:
1. Remove the inner container and individually prepackaged green leaflet actuator from the outer tray.
2. Holding the inner container, remove the tape seal (located at the end of the inner container, opposite
the valve end) by grasping the exposed tab and peeling it away. Discard the tape seal. Holding the
inner container vertically, with the loose end cap facing up, remove the end cap and discard. Reach
into the open end and grasp the green handle rotator, pulling up gently to remove the graft from the
container. Discard the inner container.
3. Peel open the pouch and remove the green leaflet actuator.
6.3. Device Implantation
Proper prosthesis size selection is an important part of heart valve replacement. Care must be exercised
to avoid using too large or too small of a prosthesis. Size of the prosthesis is determined using the
Medtronic Open Pivot standard valve sizers (Figure 3).
Inspection of the AVG should be performed immediately before implantation.
Warning: Do not touch the valve (leaflets/orifice) except with the leaflet actuator supplied with the AVG.
Touching the valve with gloved fingers or any surgical instrument may cause damage to the valve surface
that cannot be seen with the unaided eye. Such damage may serve as a nidus for thrombus formation.
The damage may also lead to leaflet escape or accelerated structural deterioration of the valve.
Caution: Do not use the AVG if it has been dropped, damaged, or mishandled in any way. Should the
AVG be damaged during implantation or removal from the package, do not use it for implantation.
Only use accessories provided by Medtronic to handle the valve. All accessories should be inspected prior
to use. Do not use any accessory if the surface appears damaged or cracked.
6.4. Suturing Techniques
6.4.1. Valve Suturing Techniques
Ensure proper orientation of the valve. Blood should always flow into the straight edge of the valve
leaflets. The markers on the sewing cuff (3 on the aortic cuff) are useful in proper placement of the sutures
and orientation of the valve. The aortic markers are 120° apart and may be placed at the approximate
location of the commissures of the excised valve. Further orientation of the valve, if necessary, can be
done with the handle rotator once the valve is seated in the annulus.
Medical practice has evolved numerous acceptable suture methods. The technique used should be based
on the patient’s anatomy, procedure requirements, and surgeon preference. Surgeons performing aortic
valve replacements frequently use interrupted everting mattress sutures. Alternatives include interrupted
figure of eight sutures or interrupted simple mattress sutures.
Pledgets may be used at the discretion of the surgeon for support of the annulus if necessary. Care should
be taken to assure that pledgets or tissue do not interfere with leaflet motion. Everting stitches with
pledgets would be useful in avoiding situations where tissue might impede leaflet motion.
After sutures are placed in the valve cuff and the valve is seated in the tissue annulus, the valve is
released from the valve holder by sliding a scalpel down the holder slot to cut the green suture and
release the valve holder. The green suture and valve holder remain attached to the handle rotator.
Carefully withdraw the handle rotator from the conduit. The suture knots can be tied at this point.
Caution: Long suture ends must be avoided since these can interfere with leaflet motion.
8 Instructions for Use English
6.4.2. Hemashield Woven Double Velour Vascular Graft Suturing
The techniques for implanting the Hemashield woven double velour vascular graft are similar to those
used for any vascular graft.
6.5. Leaflet Motion Assessment and Valve Rotation
Leaflet motion is assessed using the leaflet actuator.
Using the leaflet actuator, test leaflet motion. If the leaflets do not move freely, the valve orifice may be
rotated either clockwise or counterclockwise to a more optimal position. Rotate the orifice only after tying
the suture knots, securing the cuff to the tissue annulus. Use only the rotators provided by Medtronic to
rotate the valve. The handle rotator seats properly into the valve orifice when the radial ridge on the
handle side of the rotator head is aligned with the straight edge of the leaflets. The rotator head is
designed to contact the flat surfaces of the orifice near the pivot areas. After rotation of the valve orifice,
verify leaflet motion with the leaflet actuator.
Caution: The valve orifice and leaflets may be rotated in situ using only the appropriate handle rotator
provided by Medtronic. Do not use any other instruments for valve rotation.
7. Clinical Studies
This section contains the results of 3 separate sets of clinical data.
1. Prospective investigational studies, 1994 to 1999.
2. Additional clinical data on sizes 16/19 mm aortic valves & 24/27 mm mitral valves.
3. Additional clinical data on size 22/25 mm mitral valves.
7.1. Prospective Investigational Studies, 1994 to 1999
Patients requiring isolated aortic or mitral heart valve replacement were enrolled from 1994 to 1999 at
20 centers (17 domestic and 3 international) in a multicenter, international, prospective, nonrandomized
study. NYHA classification and blood data were obtained preoperatively, intraoperatively, and
postoperatively at 3 to 6 months, at 1 year, and annually thereafter. Hemodynamic data was obtained at
discharge and at 1 year. Patients were monitored throughout the postoperative period for possible adverse
events. The antiplatelet and anticoagulant agents used were reported. Target INRs were as follows: mitral
position, 2.5 to 3.5, and aortic position, 2.0 to 3.0 (when in normal sinus rhythm).
The cohort included 965 patients (580 men, 385 women), ages from 2 to 88 years (mean of 60.7). The
cumulative follow-up was 1323 patient-years with a mean follow-up of 1.4 years (SD = 1.2 years,
range = 0 to 5.0 years). Table 3 shows patient characteristics by age, gender, and etiology of valve
disease.
Table 3. Patient Characteristics
All patients implanted, N=965, 1323 patient-years
Description of Patients Aortic Valve n=685 (70.98%) Mitral Valve n=280 (29.02%)
Age at implant in years
0–9 5 (0.7%) 6 (2.1%)
10–19 4 (0.6%) 0 (0.0%)
20–29 11 (1.6%) 2 (0.7%)
30–39 33 (4.8%) 14 (5.0%)
40–49 72 (10.5%) 31 (11.1%)
50–59 142 (20.7%) 52 (18.6%)
60–69 238 (34.7%) 107 (38.2%)
70–79 155 (22.6%) 62 (22.1%)
80 & over 25 (3.6%) 6 (2.1%)
Gender
Male 460 (67.2%) 120 (42.9%)
Female 225 (32.8%) 160 (57.1%)
Etiology of valve disease
Stenosis 541 (79.0%) 118 (42.1%)
Insufficiency 330 (48.2%) 210 (75.0%)
Mixed 205 (29.9%) 63 (22.5%)
Other 12 (1.8%) 12 (4.3%)
Figure 4 shows the number of patients implanted versus duration of follow-up with a breakdown by valve
location (aortic and mitral). Table 4 shows the number of patients implanted for whom hemodynamic data
was collected. Table 5 shows the number of patient-years by implant size and location. Table 6
through Table 8 show effectiveness outcomes.
Instructions for Use English 9
Duration of Follow-up (Years)
Number of Patients
Total Patients Aortic Patients Mitral Patients
1000
800
600
400
200
0
0 1 2 3 4 5
Figure 4. Number of patients by implant location over time
All patients implanted, N=965
Year 0 1 2 3 4 5
Total Patients 965 624 331 135 92 2
Aortic Patients 685 436 231 93 58 2
Mitral Patients 280 188 100 42 34 0
Table 4. Number of Patients Implanted and Maximum Number of Patients with Hemodynamic Data at
>6 Months Follow-up
By implant location and valve size, N/n, n=575, N=965
Implant Location Valve size mm (Advanced Performance/Standard)
16/19 18/21 20/23 22/25 24/27 26/29 28/31/33 Total
Aortic
Mitral 0/0 3/1 5/4 3/2
2
100/61 202/108 206/113 111/70 39/32 4/4 685/405
23/17
23/18
2
71/39 175/106 280/170
Total 23/17 103/62 207/112 209/115 134/88 110/71 179/110 965/575
Notes:
1. n = number of patients with hemodynamic data; N = number of patients implanted
2. Includes data from 8 patients for the 16/19 mm aortic valve and 10 patients for the 24/27 mm mitral
valve not included in the analysis of the original patient cohort.
Table 5. Number of Patient-Years by Implant Location and Valve Size
By implant location and valve size, all patients implanted, N=965
Implant
Location
16/19 18/21 20/23 22/25 24/27 26/29 28/31 33 Total
Valve size mm (AP- AP360/Standard)
Aortic 15.7 159.3 275.0 255.6 150.1 61.1 7.4 0.0 924.2
Mitral 0.0 2.2 4.8 2.4 17.6 99.8 97.7 174.0 398.5
Total 15.7 161.5 279.8 258.0 167.7 160.9 105.1 174.0 1322.7
Table 6. Effectiveness Outcomes, Functional New York Heart (NYHA) Classification
NYHA
Class
Pre-op 1 Year
(11–14 Months)
2 Year
(23–26 Months)
3 Year
(35–38 Months)
4 Year
(47–50 Months)
n/N % n/N % n/N % n/N % n/N %
Aortic Valve Replacement, N=685
I 4/685 0.6% 399/431 92.5% 205/231 88.7% 85/94 90.4% 53/58 91.4%
II 267/685 38.9% 25/431 5.8% 20/231 8.7% 7/94 7.4% 5/58 8.6%
III 340/685 49.6% 1/431 0.2% 1/231 0.4% 0/94 0% 0/58 0%
IV 68/685 9.9% 1/431 0.2% 1/231 0.4% 0/94 0% 0/58 0%
MISS-
6/685 0.9% 5/431 1.2% 4/231 1.7% 2/94 2.1% 0/58 0%
ING
Note: N = all values reported; n = number in subgroup
10 Instructions for Use English
Table 7. Effectiveness Outcomes — Hemodynamics, Valvular Regurgitation
Valve Size (mm) No Regurgita-
(Advanced Per-
formance/Stand-
ard)
16/19 mm 33.3%, 3/9 66.7%, 6/9 0%, 0/9 0%, 0/9 0%, 0/9
18/21 mm 39.6%, 21/53 58.5%, 31/53 1.9%, 1/53 0%, 0/53 0%, 0/53
20/23 mm 33.0%, 31/94 67.0%, 63/94 0%, 0/94 0%, 0/94 0%, 0/94
22/25 mm 28.3%, 28/99 71.7%, 71/99 0%, 0/99 0%, 0/99 0%, 0/99
24/27 mm 42.6%, 26/61 55.7%, 34/61 1.6%, 1/61 0%, 0/61 0%, 0/61
26/29 mm 27.3%, 6/22 72.7%, 16/22 0%, 0/22 0%, 0/22 0%, 0/22
28/31 mm 100%, 4/4 0%, 0/4 0%, 0/4 0%, 0/4 0%, 0/4
AORTIC TOTALS 34.8%, 119/342 64.6%, 221/342 0.6%, 2/342 0%, 0/342 0%, 0/342
Notes:
1. Late is defined as 11–14 months postimplantation
2. N = all values reported; n = number in subgroup
Table 8. Effectiveness Outcomes — Hemodynamics, Mean Pressure Gradient and Effective Orifice Area
Endpoint
16/19 mm 15/23, 25.8 ± 5.1 (10.5, 49.0) 9/23, 20.2 ± 2.8 (15.0, 26.6)
18/21 mm 87/100, 18.7 ± 1.7 (2.4, 42.0) 61/100, 18.0 ± 1.6 (7.0, 36.0)
20/23 mm 181/202, 14.3 ± 0.8 (2.6, 37.0) 107/202, 13.1 ± 0.8 (5.1, 30.1)
22/25 mm 187/206, 12.8 ± 0.8 (2.6, 29.5) 112/206, 11.1 ± 0.8 (3.2, 26.0)
24/27 mm 102/111, 10.0 ± 0.7 (1.8, 22.0) 70/111, 8.0 ± 0.8 (1.3, 16.7)
26/29 mm 38/39, 9.2 ± 1.1 (3.5, 18.0) 32/39, 7.8 ± 1.1 (2.0, 13.0)
28/31 mm 3/4, 3.0 ± 0.7 (2.6, 3.8) 4/4, 5.1 ± 3.3 (1.4, 9.3)
16/19 mm 11/23, 1.1 ± 0.2 (0.7, 1.8) 8/23, 1.2 ± 0.3 (0.8, 1.9)
18/21 mm 81/100, 1.5 ± 0.1 (0.8, 3.7) 60/100, 1.5 ± 0.1 (0.7, 3.4)
20/23 mm 165/202, 1.7 ± 0.1 (0.8, 6.6) 102/202, 1.7 ± 0.1 (0.9, 3.7)
22/25 mm 173/206, 2.0 ± 0.1 (1.1, 4.0) 103/206, 2.1 ± 0.1 (1.0, 4.9)
24/27 mm 97/111, 2.4 ± 0.2 (1.1, 4.8) 65/111, 2.5 ± 0.2 (1.5, 4.9)
26/29 mm 34/39, 3.0 ± 0.3 (1.4, 4.7) 28/39, 3.1 ± 0.4 (1.4, 5.4)
28/31 mm 3/4, 2.8 ± 0.8 (2.0, 3.4) 3/4, 3.1 ± 1.6 (1.6, 4.5)
Notes:
1. Early postoperative evaluation conducted at 30 days postimplantation or hospital discharge.
2. Late postoperative evaluation = 11–14 months postimplantation
3. N = all values reported; n = number in subgroup
tion
% patients, n/N % patients, n/N % patients, n/N % patients, n/N % patients, n/N
n/N, mean ± SD (min, max) n/N, mean ± SD (min, max)
AORTIC VALVES, N=685
Trivial Regur-
gitation
Early Late
Aortic Valve Replacement, N=685
Mean Gradient (mm Hg)
Effective Orifice Area (cm2)
Mild Regurgi-
tation
Moderate
Regurgitation
Severe Regur-
gitation
8. Postoperative Information
8.1. MRI Safety Information
Nonclinical testing and modeling has demonstrated that the Medtronic Open Pivot aortic valved graft
(Model 502) is MR conditional. A patient with this device can be safely scanned in an MR system meeting
the following conditions:
■
static magnetic field of 1.5 T and 3 T
■
maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
■
maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2.0 W/kg
(Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the Medtronic Open
Pivot AVG is expected to produce a maximum in vivo temperature rise of less than 1.8°C after 15 minutes
of continuous scanning.
In nonclinical testing, the image artifact caused by the device extends no greater than 7 mm from the
Medtronic Open Pivot AVG for a spin echo pulse sequence and 15 mm for a gradient echo pulse
sequence when imaged with a 3.0 T MRI system.
9. Individualization of Treatment
Adequate anticoagulant and/or antiplatelet therapy should be administered. Selection of an anticoagulant
and/or antiplatelet regimen is based on the particular needs of the patient and the clinical situation.
Instructions for Use English 11
9.1. Specific Patient Populations
The safety and effectiveness of the AVG 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 chronic endocarditis
■
patients requiring mitral, pulmonic or tricuspid replacement
There was limited use of the valve in patients requiring double or multiple valve replacement.
10. Patient Counseling Information
■
Patients with prosthetic valves who undergo dental or potentially bacteremic procedures should
receive antibiotic prophylaxis.
■
All mechanical prosthetic heart valves produce sound as a function of their operation. Patients should
be advised of this prior to implantation.
■
Patients require anticoagulation and/or antiplatelet 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 AVG is packaged and sterilized in a transparent double-barrier container. The aortic valve is
premounted on a holder attached to a handle rotator. All package labeling is color-coded blue. The handle
rotator accessories are color-coded green to identify the aortic valve.
The valve package (Figure 1) includes:
■
outer tray
■
inner container
■
aortic valved graft, valve holder, handle rotator assembly
■
Instructions for Use
■
Patient Registration Form
■
green leaflet actuator
All packaging material is recyclable. Manage disposal in accordance with local statutory regulations.
11.2. Accessories
The valve sizers, supplied separately, are supplied nonsterile, and must be cleaned and sterilized prior to
use. The valve sizers are available to the implanting surgeon as an aid in selecting the appropriate
prosthesis size. Each set of sizers is packaged with Instructions for Use specific to the sizer.
The green leaflet actuator is available for testing valve leaflet motion, and is the only instrument approved
for testing leaflet motion.
All packaging material is recyclable. Manage disposal in accordance with local statutory regulations.
11.3. Storage
For maximum protection and product identification, store the valve in its original packaging. The storage
environment should be clean, cool, and dry, the sterility and nonpyrogenicity of the valve is validated to
remain unaffected until the Use-By Date printed on the product, provided the seals and containers are not
opened or damaged.
11.4. Returned Product Information
For detailed information on the Medtronic returned product policy, please contact your local representative.
11.5. Return of Explanted Prosthesis
Medtronic is interested in obtaining recovered clinical specimens of the AVG. Specific studies of the
explant may be performed and a written report summarizing the findings will be returned to the implanting
physician. Please contact Medtronic to obtain a Returned Material Authorization (RMA). The explanted
AVG should be placed completely submersed in a 2% to 5% formalin solution immediately after excision
unless otherwise directed by your Medtronic representative.
12. Accessories
Refer to the Medtronic Open Pivot heart valve accessories Instructions for Use for cleaning instructions.
12.1. Sizers
A complete set of Medtronic Open Pivot heart valve sizers must be cleaned and sterilized prior to surgery
and made available in the operating room. Refer to the Medtronic Open Pivot heart valve accessories
Instructions for Use for cleaning and sterilization guidelines.
Use only Medtronic Open Pivot heart valve sizers to estimate the patient’s tissue annulus. The Medtronic
Open Pivot heart valve sizers have a metal shaft that can be shaped allowing tissue annulus estimation.
The sizer with the diameter marked in millimeters has a clear plastic ring that allows easy tissue annulus
measurement. The sizer should pass through the patient’s tissue annulus with minimal resistance. Do not
force the sizer through the tissue annulus. Valve oversizing or undersizing should be avoided.
Caution: Oversizing may cause complications including tissue interference with leaflet motion or improper
seating resulting in perivalvular leaks. Undersizing may result in increased perivalvular leaks.
12 Instructions for Use English
12.2. AVG Sizing — White Handle Sizer
The white handle sizer set must be used for sizing of the AVG. The nominal diameter of the sizer in
millimeters is printed on the sizer handle. The sizer selected should pass through the patient’s annulus
without resistance but still provide a snug fit between the sizer ring and tissue annulus.
12.3. AVG and Handle Rotator Assembly
The AVG is mounted on a disposable holder that is attached to a rotator (Figure 2). The rotator is used to
rotate the valve in situ. The blood flow is always into the straight edge of the leaflets.
12.4. Sterilization/Resterilization of Accessories
The accessories must be sterilized prior to use. Validation studies were performed using a gravity
displacement sterilizer. The sterilization/resterilization of the sizer accessories should be performed
according to the Medtronic Open Pivot heart valve accessories Instructions for Use.
Caution: Do not resterilize the AVG.
Caution: Do not sterilize the holder rotator in the tray. Remove the accessories from the tray. Place the
accessories inside legally marketed sterilization wrap for sterilization.
Caution: Extreme care must be exercised when handling the valve holder assembly to avoid structural
damage to the valve. Inspect each accessory before each use. Cracked or damaged accessories must not
be used.
13. Patient Information
13.1. Registration Information
Note: Patient registration does not apply in countries where patient privacy laws conflict with providing
patient information, including countries from the European Union. A patient registration form is included in
each device package. After implantation, please complete all requested information. The serial number
may be found on the tray and box label. Return the original form to the Medtronic address indicated on the
form, and provide the temporary identification card to the patient prior to discharge.
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 the event of an emergency.
13.2. Patient Information Booklet
Medtronic has made available a Patient Information Booklet that the physician may choose to provide to
the patient prior to discharge. Copies of this booklet are available on request from your local sales
representative.
14. Disclaimer of Warranty
THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES CUSTOMERS ONLY:
ALTHOUGH THE MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT, HEREAFTER REFERRED TO
AS “PRODUCT,” HAS 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.
Instructions for Use English 13
Authorized Representative in the European
*M951907A002*
Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31 45 566 8000
Australia
Medtronic Australasia Pty. Ltd.
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670
Canada
Medtronic of Canada Ltd.
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
Tel. +1 905 460 3800
Toll-free: +1 800 268 5346
United States
Manufacturer:
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
Internet: www.medtronic.com
Tel. +1 763 526 7890
Toll-free: +1 877 526 7890
(24-hour consultation service)
Manufactured In
Medtronic, Inc.
3800 Annapolis Lane
Minneapolis, MN 55447
USA
© 2012, 2015, 2016 Medtronic, Inc.
M951907A002 Rev. 1B
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