St. Jude Medical TFGT-19A User manual

Trifecta™ Valve with Glide™Technology (GT)
TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, TFGT-29A
Instructions for Use

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the
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Pat. http://patents.sjm.com

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EN: English
Sterile components: Trifecta ™valve with Glide™Technology (GT), valve collar and holder.
Non-sterile components: Exterior of the valve jar, Trifecta™sizers, and holder handles.
Description
CAUTION: The Trifecta™Valve with Glide™Technology (GT) should be used only by physicians who have undergone
training on implantation of this device.
The Trifecta™Valve with Glide™Technology (GT) (hereafter referred to as "the valve") is a tri-leaflet stented pericardial valve designed for
supra-annular placement in the aortic position. The valve is fabricated using a polyester-covered titanium stent. The titanium stent and a
titanium band within the sewing cuff provide radiopacity for visualization of the valve.
The stent, excluding the sewing cuff, is covered with porcine pericardial tissue. This covering provides protection from mechanical wear
by allowing only tissue-to-tissue contact during valve function. Polyester fabric is rolled/folded within the sewing cuff to contour to the
annulus shape. The cuff features three suture markers that may be used to provide reference points during implantation.
The valve leaflets are fabricated from bovine pericardium. The porcine and bovine pericardium are preserved and crosslinked in
glutaraldehyde. Glutaraldehyde, formaldehyde and ethanol are used in the valve sterilization process.
The valve is processed using the Linx™anticalcification treatment. The valve is supplied sterile and non-pyrogenic.
Table 1. Valve Catalog Numbers and Reference Dimensions
Catalog
Number
Tissue Annulus Diameter
(mm)
Cuff Outer Diameter
(mm)
Total Height
(mm)
Aortic Protrusion
(mm)
Mean Implanted
Height* (mm)
TFGT-19A 19 24 15 12 14
TFGT-21A 21 26 16 13 15
TFGT-23A 23 28 17 13 16
TFGT-25A 25 31 18 14 17
TFGT-27A 27 33 19 15 18
TFGT-29A 29 35 20 16 19
*Implanted height differs from total height since the Trifecta GT cuff is compressed when it is sutured into place, as observed through
simulated bench testing of all Trifecta GT valve sizes
Figure 1. Trifecta™Valve with Glide™Technology (GT)
1. Cuff outer diameter
2. Aortic protrusion
3. Tissue annulus diameter
4. Total height
Indications for Use
The Trifecta™Valve with Glide™Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or
prosthetic aortic heart valve.
Contraindications
None known.
Warnings
For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate
sterilization, or patient harm.
Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the
native annulus measurement falls between two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifecta Sizers for
sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage,
diminished tissue durability, and/or damage to the surrounding tissues.
Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not
recommended.
Accelerated deterioration due to calcific degeneration of the valve may occur in:
-Children, adolescents, or young adults

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-Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
-Individuals requiring hemodialysis
Do not use if:
-The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
-The expiration date has elapsed.
-The tamper-evident jar seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
-The storage solution does not completely cover the valve.
Use only the Trifecta™Model TF2000 sizers1for sizing the valve.
The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair
valve function.
Precautions
Safety and effectiveness of the valve has not been established for the following specific populations:
-Patients who are pregnant
-Nursing mothers
-Patients with chronic renal failure
-Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
-Patients with chronic endocarditis
-Patients requiring pulmonic or tricuspid valve replacement
-Children, adolescents, or young adults
Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed
sizer set components.
Do not place the non-sterile exterior of the valve jar in the sterile field.
Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly
stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile isotonic saline solution
used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
Do not add antibiotics to either the valve storage solution or the rinse solution.
Do not apply antibiotics to the valve.
Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve
storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
Do not implant the valve without thoroughly rinsing as directed.
Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
Never handle the leaflet tissue.
Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the
solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.
Use caution when placing sutures through the sewing cuff to avoid lacerating the valve tissue. If a valve is damaged, the valve must
be replaced.
Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
Do not attempt to repair a valve. Damaged valves must not be used.
Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
Use caution when tying knots to avoid bending the stent posts.
Magnetic Resonance (MR) Safety
Non-clinical testing has demonstrated the Trifecta™Valve with Glide™Technology (GT) 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 tesla (1.5T) or 3.0 tesla (3.0T)
Maximum spatial field gradient of 3,000 gauss/cm (30 T/m).
Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (Normal Operating Mode).
RF Heating
Under the scan conditions defined above, the Trifecta™Valve with Glide™Technology (GT) is expected to produce a maximum
temperature rise of less than 3ºC after 15 minutes of continuous scanning.
MR Artifacts
In non-clinical testing, the image artifact extended radially 0.6 cm from the prosthetic valve when imaged with a gradient echo pulse
sequence and a 3.0T System.
1TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

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CAUTION: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable
heating at one field strength may exhibit high values of localized heating at another field strength.
Adverse Events
The Trifecta™Valve with Glide™Technology is based upon the Trifecta™Valve design. Therefore, a previous clinical investigation of the
Trifecta Valve supports the safety of the Trifecta Valve with Glide Technology. Between June 2007 and November 2009, one thousand
and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States
(18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The
cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38
years).
Adverse events potentially associated with the use of bioprosthetic heart valves include:
angina
cardiac arrhythmias
endocarditis
heart failure
hemolysis
hemolytic anemia
hemorrhage
leak, transvalvular or paravalvular
myocardial infarction
nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
prosthesis regurgitation
stroke
structural deterioration (calcification, leaflet tear, or other)
thromboembolism
valve thrombosis
It is possible that these complications could lead to:
reoperation
explantation
permanent disability
death
See the Clinical Study section of these instructions for adverse event data collected in the Trifecta™Valve clinical investigation.
Clinical Study
The Trifecta™valve with Glide™Technology is based upon the Trifecta™valve design. Therefore, a previous clinical investigation of the
Trifecta valve supports the safety and efficacy of the Trifecta valve with Glide Technology. The Trifecta valve clinical investigation was a
prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and
effectiveness of the Trifecta valve. Adverse Event (AE) rates as compared to a set of Objective Performance Criteria (OPC) and to
literature-based control data were used for the design and analysis of this study. New York Heart Association (NYHA) functional
classification status and hemodynamic performance of the valve by echocardiography were evaluated. The NYHA functional classification
data and hemodynamic data were compared to literature-based control data.
One thousand and twenty-two (1022) subjects were implanted with the Trifecta Valve between June 2007 and November 2009 at 31
investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on one thousand and fourteen (1014)
subjects who met eligibility criteria. Preoperative demographic and baseline data including NYHA functional classification were collected.
Postoperative data, including blood and echocardiography data, were collected at discharge, 6 months, one year, and annually thereafter.
All echocardiograms were interpreted by the same Echocardiography Core Laboratory. Postoperative NYHA functional classifications were
collected at 6 months, one year, and annually thereafter. Adverse Event data shown in the following table were collected at the time of
occurrence or upon site notification.
The mean age at implant was 72.5 years (standard deviation (SD) 9.0 years, range 32 - 95 years). Preoperatively, 49.3% of subjects were
NYHA functional classification III/IV and 64.1% of subjects were male. The cumulative follow-up was 924.18 patient-years with a mean
follow-up of 0.91 years (SD 0.49 years, range 0 - 2.38 years).
Table 2. Observed Adverse Event Rates
All subjects analyzed: N=1014
Cumulative follow-up: 924.18 patient-years
Adverse Event
Early Events2
%3 (n)
Late Events4
% / pt-yr5(n)
Freedom From Event
1 Year6
Freedom From Event
2 Year7
2Early events are those occurring on or before 30 days post-implant
3The early adverse event rate (%) is calculated as the number of early adverse events divided by the total number of subjects, times 100

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[One-Sided Upper 95%
CL]
% [95% CI]
% [95% CI]
Thromboembolism 2.7% (27) 1.90% (16) [2.88%] 96.2% [94.7%, 97.2%] 92.9% [88.5%, 95.6%]
Valve Thrombosis 0.0% (0) 0.00% (0) [0.35%] 100.0% [100.0%, 100.0%] 100.0% [100.0%, 100.0%]
Major Bleed 8.0% (81) 2.61% (22) [3.72%] 90.4% [88.3%, 92.2%] 86.0% [81.0%, 89.8%]
-Anticoagulant
and/or Antiplatelet
1.4% (14) 1.90% (16) [2.88%] 96.8% [95.4%, 97.8%] 93.7% [88.7%, 96.5%]
Nonstructural Dysfunction 0.3% (3) 0.12% (1) [0.56%] 99.6% [98.9%, 99.8%] 99.6% [98.9%, 99.8%]
All Perivalvular Leak 0.1% (1) 0.00% (0) [0.35%] 99.9% [99.3%, 100.0%] 99.9% [99.3%, 100.0%]
-Major Perivalvular Leak 0.0% (0) 0.00% (0) [0.35%] 100.0% [100.0%, 100.0%] 100.0% [100.0%, 100.0%]
Endocarditis 0.0% (0) 1.07% (9) [1.86%] 99.1% [98.1%, 99.5%] 98.6% [97.1%, 99.4%]
Clinically Significant
Hemolysis
0.0% (0) 0.0% (0) [0.35%] 100.0% [100.0%, 100.0%] 100.0% [100.0%, 100.0%]
Structural Deterioration 0.0% (0) 0.12% (1) [0.56%] 99.9% [99.3%, 100.0%] 99.9% [99.3%, 100.0%]
Reoperation 0.1% (1) 0.59% (5) [1.25%] 99.4% [98.6%, 99.7%] 99.4% [98.6%, 99.7%]
- Explant 0.1% (1) 0.59% (5) [1.25%] 99.4% [98.6%, 99.7%] 99.4% [98.6%, 99.7%]
Valve-Related Mortality 0.2% (2) 0.36% (3) [0.92%] 99.4% [98.6%, 99.8%] 99.4% [98.6%, 99.8%]
Follow-Up
The following table presents the number of eligible subjects meeting all inclusion/exclusion criteria, cumulative and late patient-years, and
mean follow-up.
Table 3. Eligible Subjects, Cumulative and Late Patient-Years, and Mean Follow-up
All subjects included in analysis: N=1014
Implant Duration
Number of
subjects
Total Patient-
years
Mean
SD
Minimum
Maximum
Cumulative Patient-years 1014 924.18 0.91 0.49 0.00 2.38
Late Patient-years8995 844.31 0.88 0.45 0.01 2.30
Preoperative Subject Demographics
The following table presents the preoperative subject demographics.
Table 4. Preoperative Subject Demographics
All subjects included in analysis: N=1014
Variable
N=1014
Age at Implant (years) 72.5 ± 9.0 (32,95)
Subject Gender (Male) 64.1% (650)
Preoperative NYHA
Class I 6.6% (67)
Class II 44.1% (447)
Class III 43.9% (445)
Class IV 5.4% (55)
Effectiveness Outcomes
Quantitative data were collected throughout the study (i.e., NYHA functional classification, echo parameters). The following tables present
subject NYHA classification preoperatively compared to one year follow-up and two years follow-up, respectively.
4Late events are those occurring 31 days post-implant or thereafter
5Late adverse event rate (%/pt-yr) is calculated as the number of late events divided by the total late patient-years, times 100. The late adverse event rates were calculated based on
844.31 late patient-years
6Freedom from event estimates at 1 year and at 2 years from Kaplan-Meier analysis are calculated based on 12 months and 24 months, respectively (where 30.4 days = 1 month)
7Freedom from event estimates at 1 year and at 2 years from Kaplan-Meier analysis are calculated based on 12 months and 24 months, respectively (where 30.4 days = 1 month)
8Late patient-years are determined from 31 days post-implant to the last follow-up visit (or contact), or adverse event.

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Table 5. Effectiveness Outcomes, NYHA Functional Classification: 1 year Follow-up9
Subjects with both preoperative and 1 year NYHA measurements, N=606; n1=number per subgroup
NYHA Class
N=606
Preoperative
1 Year
n1
% (n1/N)
n1
% (n1/N)
I 34 5.6% 517 85.3%
II 275 45.4% 82 13.5%
III
273
45.0%
7
1.2%
IV 24 4.0% 0 0.0%
All 606 100.0% 606 100.0%
Table 6. Effectiveness Outcomes, NYHA Functional Classification: 2 year Follow-up10
Subjects with both preoperative and 2 year NYHA measurements, N=97; n1=number per subgroup
NYHA Class
N=97
Preoperative
2 Year
n1
% (n1/N)
n1
% (n1/N)
I 8 8.2% 81 83.5%
II 45 46.4% 14 14.4%
III 36 37.1% 2 2.1%
IV
8
8.2%
0
0.0%
All 97 100.0% 97 100.0%
The following table presents the hemodynamic follow-up results for the Trifecta valve replacements.
Table 7. Effectiveness Outcomes at 1 Year Follow-up Visit, Hemodynamic Results
All subjects included in data analysis: N=1014
Hemodynamic
Parameter
19 mm
21 mm
23 mm
25 mm
27 mm
29 mm11
N=6812
N=160
N=198
N=136
N=40
N=15
Mean Gradient13 n=6614 n=160 n=197 n=135 n=40 n=15
-Mean ± SD
10.7 ± 4.6
8.1 ± 3.5
7.2 ± 2.8
6.2 ± 2.7
4.8 ± 2.0
4.7 ± 1.6
-Min, Max 3.3, 26.4 0.6, 23.7 1.0, 19.5 1.4, 20.3 0.5, 9.8 2.0, 7.1
EOA15 n=60 n=151 n=190 n=129 n=38 n=13
-Mean ± SD 1.41 ± 0.24 1.63 ± 0.29 1.81 ± 0.30 2.02 ± 0.32 2.20 ± 0.20 2.35 ± 0.22
-Min, Max 0.91, 2.19 0.87, 2.58 0.78, 2.77 1.15, 2.76 1.86, 2.82 2.02, 2.73
Regurgitation16 n=68 n=160 n=198 n=136 n=40 n=15
-None 64.7% (44) 74.3% (119) 73.7% (146) 74.2% (101) 75.0% (30) 80.0% (12)
-Trivial 25.0% (17) 22.5% (36) 23.2% (46) 19.1% (26) 22.5% (9) 20.0% (3)
-Mild 2.9% (2) 1.8% (3) 0.5% (1) 3.6% (5) 0.0% (0) 0.0% (0)
-Moderate 1.4% (1) 0.6% (1) 0.5% (1) 1.4% (2) 2.5% (1) 0.0% (0)
-Severe 0.0% (0) 0.0% (0) 1.0% (2) 0.7% (1) 0.0% (0) 0.0% (0)
-Unknown17 5.8% (4) 0.6% (1) 1.0% (2) 0.7% (1) 0.0% (0) 0.0% (0)
9Subjects with both preoperative and one year NYHA measurements available are included in this table
10 Subjects with both preoperative and 2 year NYHA measurements available are included in table
11 Data for size 29 mm are based on follow-up cutoff date of 10/26/2010. All other data in table are based on follow-up cutoff date of 3/25/2010
12 N= number of subjects with a completed echo per valve size
13 Mean Gradient= pressure drop measured across the valve recorded in mmHg
14 n= number of subjects per valve size with available hemodynamic parameter
15 EOA= calculated effective orifice area measured in cm2
16 Aortic Regurgitation presented as ‘Percentage (Count)’
17 Unknown - Includes echoes that did not contain the appropriate images to evaluate aortic regurgitation

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Packaging and Storage
The valve is packaged in a jar with formaldehyde storage solution. A retaining collar stabilizes the valve within the jar.
As delivered, the valve is attached to a valve holder by retaining sutures. The valve holder facilitates handling and manipulation of the
valve during removal from the jar, rinsing, and implantation.
Store the valve in the upright position.
CAUTION: Do not implant the valve without thoroughly rinsing as directed.
CAUTION: Do not use the valve if the shipping temperature indicators on the product carton have turned red, or if the
valve has been improperly stored in temperature conditions outside of the 5°C - 25°C (41°F - 77°F range).
Accessories
The following sizer set and accessories are available for use with the valve:
Sizer Set
Trifecta™Valve Series Sizer Set Model TF2000-2 (includes TF2000 sizers, Rigid Holder Handle Models T2002-R and UT2000-R).
UT2000-R is not compatible with the valve.
Optional Handles
Flexible Holder Handle Model T2002
Rigid Extension Handle Model EX2000-R
Flexible Extension Handle Model EX-05
Optional handles may not be available in all locations. Please contact your local St. Jude Medical representative.
Directions for Use
Sizing the Valve
CAUTION: Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked,
crazed, or deformed sizers.
WARNING: Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the
sinotubular junction. If the native annulus measurement falls between two valve sizes, use the smaller size valve. Use
only the Model TF2000 Trifecta Sizers for sizing the valve. Implantation of an oversized valve may result in stent
deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding
tissues.
Use only Model TF2000 sizers to size the valve. The TF2000 sizer is a double-ended tool with a cylindrical annular sizing end and a valve
replica end. Use the cylindrical annular sizing end of the sizer to determine the annulus size. Select the valve size using the cylindrical
annular sizing end that passes readily without resistance through the annulus. See the sizer instructions for use for specific instructions on
cleaning, sterilization, and handling.
Figure 2. TF2000 Sizer
1. Replica end
2. Cylindrical annular sizing end
The valve is designed for implantation in the supra-annular position. Use the replica end of the sizer to visualize placement of the sewing
cuff above the annulus, and to confirm placement and fit of the valve in the supra-annular space.

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Figure 3. Sizing the valve
The replica end of the TF2000 sizer may be used to visualize placement of the sewing cuff above the annulus and to confirm the fit of
the valve in the supra-annular space.
CAUTION: Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
Pre-Implant Handling
The valve is supplied in a storage jar with a screw-cap closure and tamper-evident seal. The contents of the jar are sterile, and must be
handled aseptically to prevent contamination.
WARNINGS
Do not use the valve if the expiration date has elapsed.
Do not use the valve if fluid is leaking from the packaging.
Do not resterilize the valve by any method.
Removing the Valve from the Outer Package
PRECAUTIONS:
Do not place the non-sterile exterior of the valve jar in the sterile field.
Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile
isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
Do not add antibiotics to either the formaldehyde storage solution or the rinse solution.
Do not apply antibiotics to the valve.
Select the appropriate valve size, as determined from the sizing procedure.
Once the valve jar has been removed from the outer packaging, examine the jar for evidence of damage.
WARNING: The valve must not be implanted if the tamper- evident jar seal is damaged, broken, or missing, or if fluid is
leaking from the packaging.
WARNING: The valve must not be implanted if the storage solution does not completely cover the valve.
Verify the valve size and expiration date on the label.
To remove the valve from the jar, break the seal and remove the screw-top closure.
CAUTION: Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush
any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical
care.
Removing the Valve from the Jar
Select the Rigid Holder Handle Model T2002-R, or the Flexible Holder Handle Model T2002, for the procedure.
NOTE: The valve must be removed from the jar using a threaded screw-in holder handle. The click-in Model UT2000-R holder
handle provided with the Model TF2000-2 sizer set is not compatible with the valve.
With the circulating nurse holding the jar, screw the holder handle into the valve holder by rotating the handle in the clockwise
direction, as shown (page 8). Ensure a secure connection.

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NOTE: To prevent cross-threading, keep the holder handle perpendicular to the valve holder during attachment.
Remove the valve from the jar.
NOTE: The leaflets only coapt upon closure during the cardiac cycle. See leaflet outflow view illustration (page 8).
CAUTION: Do not handle the valve with unprotected forceps. Do not use cutting edge needles or sharp instruments.
Never handle the leaflet tissue.
Using gloved hands, grasp the plastic retaining collar with one hand and the holder handle with the other hand. Lift up on the holder
handle, then slide the holder handle out of the slot in the retainer collar, as shown (page 9).
Inspect the valve for damage. Do not implant the valve if there is any sign of damage or deterioration.
Figure 4. Use the holder handle to remove the valve from the jar
Screw the holder handle into the valve holder and ensure a secure connection.
Figure 5. Leaflet outflow view