Hancock™ II
Bioprosthesis
T505, T510
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
Sterile LC: Device has been sterilized using liquid chemical sterilants according to EN/ISO 14160.
Size
Do not reuse
Do not resterilize
Use-by date
Quantity
For US audiences only
Temperature limitation
Serial number
Catalog number
Manufacturer
Date of manufacture
Authorized representative in the European Community
MR Conditional
Manufactured in
Do not use if indicator turns black
Model
1
Figure 1. Opening the valve container
Figure 2. Removing the retainer from the jar
Figure 3. Verifying the serial number and removing the retainer cap
Figure 4. Inserting the valve handle into the Cinch™ holder
2
Figure 5. Removing the valve from the retainer and rinsing
Figure 6. Ratcheting the Cinch holder (aortic)
Figure 7. Removing the Cinch holder (aortic)
Figure 8. Nondeflected Cinch holder (aortic)
3
1. Visible
Figure 9. Fully deflected Cinch holder (aortic)
Figure 10. Ratcheting the Cinch holder (mitral)
Figure 11. Removing the Cinch holder (mitral)
Figure 12. Nondeflected Cinch holder (mitral)
4
Figure 13. Fully deflected Cinch holder (mitral)
Figure 14. Right fibrous trigone (mitral)
5
Bioprosthesis
1. Device description
The Hancock™ II bioprostheses, Model T505 (aortic) and Model T510 (mitral) consist of porcine aortic valves that have been
preserved in stabilized (0.2%) glutaraldehyde with a pressurized aortic root fixation process, and fitted and secured to clothcovered flexible stents. The fixation and preservation with buffered glutaraldehyde solutions minimize the immunogenic
potential on the porcine tissue. Hancock II bioprostheses are treated with a surfactant, sodium dodecyl sulfate (“T6”).
The Hancock II bioprostheses are designed for both the aortic position (Model T505) and mitral position (Model T510). The
sewing ring diameter on the Hancock II Ultra™ bioprosthesis has been reduced to facilitate implantation in patients with small
aortic roots.
The Hancock II bioprostheses are available in the sewing ring diameters and sizes shown in Table 1, Table 2, and Table 3.
Table 1. Hancock II aortic bioprosthesis, Model T505, available sizes and sewing ring diameters
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
Aortic protrusion
(±0.5 mm)
21 18.5 27.0 15.0 12.0
23 20.5 30.0 16.0 13.5
25 22.5 33.0 17.5 15.0
27 24.0 36.0 18.5 15.5
Nominal values in millime-
29 26.0 39.0 20.0 16.0
ters
a
Stent O.D. equivalent to annulus diameter
Table 2. Hancock II Ultra aortic bioprosthesis small root system, Model T505, available sizes and sewing ring diameters
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
Aortic protrusion
(±0.5 mm)
21 18.5 26.0 15.0 12.0
23 20.5 28.0 16.0 13.5
25 22.5 30.0 17.5 15.0
27 24.0 32.0 18.5 15.5
Nominal values in millime-
29 26.0 34.0 20.0 16.0
ters
a
Stent O.D. equivalent to annulus diameter
Table 3. Hancock II mitral bioprosthesis, Model T510, available sizes and sewing ring diameters
E
E
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
E
Mitral protrusion
(±0.5 mm)
25 22.5 33.0 18.0 13.5
27 24.0 35.0 19.0 14.0
29 26.0 38.0 20.5 15.5
31 28.0 41.0 22.0 17.0
Nominal values in millime-
33 30.0 43.0 23.0 17.5
ters
a
Stent O.D. equivalent to annulus diameter
2. Indications for use
The Hancock II bioprostheses are indicated for patients who require replacement of their native or prosthetic aortic and/or mitral
valves.
3. Contraindications
No contraindications for use of this device are known.
6 Instructions for Use English
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 or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
Check the shipping temperature indicator inside the carton. If the shipping temperature indicator window is black, the valve is
not suitable for clinical use.
Do not resterilize the valve by any method. Exposure of the bioprosthesis and container to irradiation, steam, ethylene oxide
or other chemical sterilants will render the bioprosthesis unfit for use.
Do not use the bioprosthesis if:
■
The bioprosthesis 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 serial number tag does not match the container label
■
The shipping temperature indicator window has turned black
■
The glutaraldehyde storage solution does not completely cover the bioprosthesis
Do not expose the bioprosthesis to solutions other than the storage solution in which it was shipped, the sterile isotonic saline
solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the bioprosthesis.
Do not add antibiotics to either the storage or the rinse solution. Do not apply antibiotics to the bioprosthesis.
Do not allow the valve tissue to dry. Maintain tissue moisture with irrigation or immersion in normal saline solution during
surgery.
Do not attempt to repair a damaged bioprosthesis.
Do not use cutting needles, as they may cause structural damage to the fabric of the bioprosthesis.
Do not pass a catheter, surgical instrument, or transvenous pacing lead through the bioprosthesis, as this may damage the
valve.
4.2. Precautions
■
Accelerated deterioration due to calcific degeneration of bioprostheses may occur in:
■
Children, adolescents, or young adults
■
Patients with altered calcium metabolism (eg, chronic renal failure, hyperparathyroidism)
■
A replacement prosthesis should fit the native annulus snugly without overdistension.
■
Avoid suture entanglement with the mitral stent posts and verify by examining the ventricular aspect of the implanted
bioprosthesis.
■
When using interrupted sutures, it is important to cut the sutures close to the knots and to ensure that exposed suture tails
will not come into contact with the leaflet tissue.
■
Care must be exercised when placing sutures through the sewing ring to avoid possible laceration of the leaflet tissue.
5. Adverse events
Medtronic long-term clinical study
A multi-center evaluation was conducted of patients implanted with the Hancock II bioprosthesis, with patient follow-up out to
12 years for some patients. Two hundred sixty-seven (267) patients had isolated aortic valve replacement (AVR) and
102 patients had isolated mitral valve replacement (MVR). Patients were evaluated within 30 days of surgery, and on an annual
basis through 1992. Since 1993, patients were evaluated once every other year. Adverse events were captured throughout the
postoperative period.
Toronto case series
A case series of patients implanted with the Hancock II bioprosthesis was conducted, with patient follow-up out to 14 years for
some patients. Seven hundred ten (710) patients had isolated aortic valve replacement (AVR) and 308 patients had isolated
mitral valve replacement (MVR). Patients were implanted between September 1982 and December 1994. Patients were
evaluated preoperatively, within 30 days of surgery, and at the following follow-up intervals: 1991, 1992-1993, 1994, and 1996.
The first occurrence of device-related adverse events was captured (multiple events were not captured) throughout the
postoperative period.
5.1. Observed adverse events
The following tables present early (<30 days for valve-related adverse events, <30 days or during hospitalization for death),
linearized and cumulative freedom from adverse event rates. A linearized rate is not calculated for death, structural valve
Instructions for Use English 7
deterioration, nonstructural valve dysfunction, reoperation, and death, since these rates are not constant over time. The
denominator used for calculation of the linearized rates was constant in the Medtronic Long-Term Clinical Study (it included
only patient-years beyond 30 days), whereas the denominator in the Toronto Case Series varied because patients were
censored when the first event of each complication was reported (multiple events were not included).
Medtronic long-term clinical study: AVR
The adverse event rates were based on 267 bioprostheses implanted in 267 patients at 7 centers. The cumulative follow-up
was 1889 patient-years with a mean follow-up of 7 years (SD=4 years, range=0 to 12 years).
Table 4. Observed Adverse Event Rates for AVR Medtronic Long-Term Clinical Study All patients analyzed: N=267 Cumulative
follow-up = 1889 patient-years
Adverse Event Early Events Late Events
a
N % of Patients N % /Patient-
Year
All Deaths 12 4.5 120 —
Valve-Related or Unexplained 0 0 32 —
Valve-Related Adverse Events
Thromboembolism
b
2 0.7 37 2.0
Permanent Neurological Event 2 0.7 19 1.0
Transient Neurological Event 0 0 16 0.9
Primary Valve Thrombosis 0 0 3 0.2
Structural Valve Deterioration 0 0 11 —
Nonstructural Valve Dysfunction
c
0 0 2 —
Endocarditis 3 1.1 12 0.6
Periprosthetic Leak
d
0 0 6 0.3
Major Anticoagulant Related Hemorrhage 0 0 5 0.3
Reoperation 0 0 23 —
Explant 0 0 22 —
a
Late event rates were calculated as linearized rates (%/patient-year) based on 1867.6 patient-years of follow-up (>30 days postoperative).
b
Two late embolic events were in peripheral arteries.
c
Due to pannus
d
No events related to endocarditis
Adverse Event Freedom From Event (%) [95% CI]
1 Year (n=237)
b
5 Years (n=180)
b
a
10 Years (n=81)
b
All Deaths 91.3 [87.9, 94.7] 72.3 [66.7, 77.9] 49.2 [41.6, 56.8]
Valve-Related or Unexplained 98.0 [96.2, 99.8] 92.9 [89.3, 96.5] 82.2 [74.6, 89.8]
Valve-Related Adverse Events
Thromboembolism
c
98.0 [96.2, 99.8] 92.9 [89.1, 96.7] 80.7 [72.1, 89.3]
Permanent Neurological Event 99.2 [98.0, 100.0] 96.7 [94.2, 99.2] 90.0 [83.7, 96.3]
Transient Neurological Event 98.8 [97.4, 100.0] 96.7 [94.2, 99.2] 91.2 [84.7, 97.7]
Primary Valve Thrombosis 99.6 [98.8, 100.0] 98.7 [97.1, 100.0] 98.7 [96.2, 100.0]
Structural Valve Deterioration 100.0 [98.7, 100.0] 100.0 [98.3, 100.0] 94.4 [89.5, 99.3]
Nonstructural Valve Dysfunction
d
99.6 [98.8, 100.0] 99.1 [97.7, 100.0] 99.1 [97.1, 100.0]
Endocarditis 98.0 [96.2, 99.8] 95.8 [92.9, 98.7] 93.0 [87.5, 98.5]
Periprosthetic Leak
e
99.6 [98.8, 100.0] 98.5 [96.7, 100.0] 95.6 [91.1, 100.0]
Major Anticoagulant Related Hemorrhage 100.0 [98.7, 100.0] 99.5 [98.5, 100.0] 98.0 [95.0, 100.0]
Reoperation 98.8 [97.4, 100.0] 96.1 [93.3, 98.8] 89.6 [83.3, 95.9]
Explant 98.8 [97.4, 100.0] 96.6 [94.0, 99.2] 90.0 [83.8, 96.2]
a
Freedom from event rates were calculated using the Kaplan-Meier method. Peto’s formula was used for the calculation of the standard errors of these estimates for the confidence intervals for adverse events
with at least 1 occurrence. For adverse events with no occurrences, the lower one-sided confidence limits were calculated as (1-maximum risk), where (1-maximum risk) = (0.05)
remaining at risk.
b
Number of patients in study 1, 5, and 10 years after implant
c
Two late embolic events were in peripheral arteries.
d
Due to pannus
e
No events related to endocarditis
1/N
, and N = number of patients
Medtronic long-term clinical study: MVR
The adverse event rates were based on 102 bioprostheses implanted in 102 patients at 7 centers. The cumulative follow-up
was 649 patient-years with a mean follow-up of 6 years (SD=4, range=0 to 12 years).
8 Instructions for Use English
Table 5. Observed Adverse Event Rates for MVR Medtronic Long-Term Clinical Study All patients analyzed: N=102 Cumulative
follow-up = 649 patient-years
Adverse Event Early Events Late Events
a
N % of Patients N % /Patient-
Year
All Deaths 13 12.7 48 —
Valve-Related or Unexplained 2 2.0 16 —
Valve-Related Adverse Events
Thromboembolism
b
3 2.9 20 3.1
Permanent Neurological Event 1 1.0 9 1.4
Transient Neurological Event 2 2.0 8 1.2
Primary Valve Thrombosis 0 0 0 0
Structural Valve Deterioration 0 0 7 —
Nonstructural Valve Dysfunction
c
0 0 0 —
Endocarditis 0 0 5 0.8
Periprosthetic Leak
d
1 1.0 1 0.2
Major Anticoagulant Related Hemorrhage 0 0 7 1.1
Reoperation 0 0 8 —
Explant 0 0 8 —
a
Late event rates were calculated as linearized rates (%/patient-year) based on 641.0 patient-years of follow-up (>30 days postoperative).
b
Two late embolic events were in peripheral arteries.
c
Due to pannus
d
No events related to endocarditis
Adverse Event Freedom From Event (%) [95% CI]
1 Year (n=82)
b
5 Years (n=65)
b
a
10 Years (n=26)
b
All Deaths 81.3 [73.7, 88.9] 67.3 [57.9, 76.7] 38.1 [26.6, 49.6]
Valve-Related or Unexplained 94.6 [89.8, 99.4] 89.6 [82.6, 96.6] 77.4 [63.3, 91.5]
Valve-Related Adverse Events
Thromboembolism
c
94.6 [89.7, 99.5] 89.3 [81.9, 96.7] 73.0 [57.5, 88.5]
Permanent Neurological Event 97.9 [94.8, 100.0] 95.3 [90.2, 100.0] 85.8 [73.1, 98.5]
Transient Neurological Event 97.9 [94.8, 100.0] 95.1 [89.8, 100.0] 91.0 [79.8, 100.0]
Primary Valve Thrombosis 100.0 [96.4, 100.0] 100.0 [95.5, 100.0] 100.0 [89.1, 100.0]
Structural Valve Deterioration 100.0 [96.4, 100.0] 98.5 [95.6, 100.0] 90.7 [80.1, 99.3]
Nonstructural Valve Dysfunction
d
100.0 [96.4, 100.0] 100.0 [95.5, 100.0] 100.0 [89.1, 100.0]
Endocarditis 100.0 [96.4, 100.0] 98.8 [96.1, 100.0] 94.6 [86.1, 100.0]
Periprosthetic Leak
e
99.0 [96.8, 100.0] 97.5 [93.7, 100.0] 97.5 [91.5, 100.0]
Major Anticoagulant Related Hemorrhage 100.0 [96.4, 100.0] 95.8 [90.9, 100.0] 89.8 [78.6, 100.0]
Reoperation 100.0 [96.4, 100.0] 98.5 [95.6, 100.0] 88.5 [77.0, 100.0]
Explant 100.0 [96.4, 100.0] 98.5 [95.6, 100.0] 88.5 [77.0, 100.0]
a
Freedom from event rates were calculated using the Kaplan-Meier method. Peto’s formula was used for the calculation of the standard errors of these estimates for the confidence intervals for adverse events
with at least 1 occurrence. For adverse events with no occurrences, the lower one-sided confidence limits were calculated as (1-maximum risk), where (1-maximum risk) = (0.05)
remaining at risk.
b
Number of patients in study 1, 5, and 10 years after implant
c
Two late embolic events were in peripheral arteries.
d
Due to pannus
e
No events related to endocarditis
1/N
, and N = number of patients
Toronto case series: AVR
The adverse event rates were based on 710 bioprostheses implanted in 710 patients at The Toronto Hospital. The cumulative
follow-up was 4064 patient-years with a mean follow-up of 6 years (SD=3 years, range=0 to 14 years).
Table 6. Observed Adverse Event Rates for AVR Toronto Case Studies All patients analyzed: N=710 Cumulative follow-up =
4064 patient-years
Adverse Event Early Events Late Events
N % of Patients N % /Patient-
Year
All Deaths 34 4.8 156 —
Valve-Related or Unexplained — — 18 —
Valve-Related Adverse Events
Thromboembolism 6 0.8 48 1.2
Instructions for Use English 9
Adverse Event Early Events Late Events
N % of Patients N % /Patient-
Year
Permanent Neurological Event 5 0.7 34 0.9
Transient Neurological Event 1 0.1 14 0.4
Primary Valve Thrombosis
Structural Valve Deterioration
a
a
0 0 0 0
0 0 10 —
Endocarditis 1 0.1 17 0.4
Major Periprosthetic Leak
a
0 0 3 0.1
Reoperation 0 0 24 —
Explant 0 0 23 —
a
Resulting in reoperation or death
Adverse Event Freedom From Event (%) [95% CI]
1 Year (n=648)
b
5 Years (n=398)
b
a
10 Years (n=80)
All Deaths 92.5 [90.5, 94.5] 80.3 [76.8, 83.8] 63.4 [55.0, 71.8]
Valve-Related or Unexplained 99.9 [99.7, 100.0] 97.9 [96.5, 99.3] 95.9 [91.9, 100.0]
Valve-Related Adverse Events
Thromboembolism 98.2 [97.2, 99.2] 94.3 [92.0, 96.6] 86.7 [79.4, 94.0]
Permanent Neurological Event 98.7 [97.8, 99.6] 95.8 [93.8, 97.8] 90.5 [84.3, 96.7]
Transient Neurological Event — — —
Primary Valve Thrombosis
Structural Valve Deterioration
c
c
100.0 [99.5, 100.0] 100.0 [99.3, 100.0] 100.0 [96.3, 100.0]
100.0 [99.5, 100.0] 99.6 [99.0, 100.0] 95.4 [90.9, 99.9]
Endocarditis 99.4 [98.8, 100.0] 97.8 [96.4, 99.2] 96.2 [92.1, 100.0]
Major Periprosthetic Leak
c
99.9 [99.7, 100.0] 99.9 [99.6, 100.0] 99.0 [96.8, 100.0]
Reoperation 99.4 [98.8, 100.0] 97.7 [96.2, 99.2] 93.0 [87.6, 98.4]
Explant 99.4 [98.8, 100.0] 97.8 [96.4, 99.2] 93.2 [87.9, 98.5]
a
Freedom from event rates were calculated using the Kaplan-Meier method. Peto’s formula was used for the calculation of the standard errors of these estimates for the confidence intervals for adverse events
with at least 1 occurrence. For adverse events with no occurrences, the lower one-sided confidence limits were calculated as (1-maximum risk), where (1-maximum risk) = (0.05)
remaining at risk.
b
Number of patients in study 1, 5, and 10 years after implant
c
Resulting in reoperation or death
1/N
, and N = number of patients
Toronto case series: MVR
The adverse event rates were based on 308 bioprostheses implanted in 308 patients at The Toronto Hospital. The cumulative
follow-up was 1720 patient-years with a mean follow-up of 6 years (SD=4 years, range=0 to 14 years).
Table 7. Observed Adverse Event Rates for MVR Toronto Case Series All patients analyzed: N=308 Cumulative follow-up =
1720 patient-years
b
Adverse Event Early Events Late Events
N % of Patients N % /Patient-
Year
All Deaths 24 7.8 89 —
Valve-Related or Unexplained — — 17 —
Valve-Related Adverse Events
Thromboembolism 1 0.3 17 0.1
Permanent Neurological Event 1 0.3 15 0.9
Transient Neurological Event 0 0 2 0.1
Primary Valve Thrombosis 0 0 1 0.1
Structural Valve Deterioration 0 0 16 —
Endocarditis 0 0 10 0.6
Major Periprosthetic Leak 0 0 2 0.1
Reoperation 0 0 21 —
Explant 0 0 20 —
Adverse Event Freedom From Event (%) [95% CI]
1 Year (n=269)
b
5 Years (n=159)
b
a
10 Years (n=43)
All Deaths 88.3 [84.7, 91.9] 72.9 [67.0, 78.8] 53.5 [42.6, 64.4]
Valve-Related or Unexplained 99.6 [98.8, 100.0] 95.9 [92.9, 98.9] 88.8 [79.9, 97.7]
10 Instructions for Use English
b
Adverse Event Freedom From Event (%) [95% CI]
1 Year (n=269)
b
5 Years (n=159)
b
a
10 Years (n=43)
Valve-Related Adverse Events
Thromboembolism 99.3 [98.3, 100.0] 94.9 [91.5, 98.3] 90.3 [81.8, 98.8]
Permanent Neurological Event 99.3 [98.3, 100.0] 95.5 [92.3, 98.7] 91.6 [83.6, 99.6]
Transient Neurological Event
Primary Valve Thrombosis
Structural Valve Deterioration
c
c
100.0 [98.9, 100.0] 100.0 [98.1, 100.0] 99.3 [96.8, 100.0]
100.0 [98.9, 100.0] 100.0 [98.1, 100.0] 83.9 [73.8, 94.0]
Endocarditis 98.9 [97.7, 100.0] 96.1 [93.1, 99.1] 95.3 [89.1, 100.0]
Major Periprosthetic Leak
c
100.0 [98.9, 100.0] 99.1 [97.6, 100.0] 99.1 [96.3, 100.0]
Reoperation 99.3 [98.3, 100.0] 98.4 [96.5, 100.0] 82.3 [72.0, 92.6]
Explant 99.7 [99.0, 100.0] 98.8 [97.1, 100.0] 82.6 [72.3, 92.9]
a
Freedom from event rates were calculated using the Kaplan-Meier method. Peto’s formula was used for the calculation of the standard errors of these estimates for the confidence intervals for adverse events
with at least 1 occurrence. For adverse events with no occurrences, the lower one-sided confidence limits were calculated as (1-maximum risk), where (1-maximum risk) = (0.05)
remaining at risk.
b
Number of patients in study 1, 5, and 10 years after implant
c
Resulting in reoperation or death
1/N
, and N = number of patients
5.2. Potential adverse events
Adverse events potentially associated with the use of bioprosthetic heart valves include:
■
Angina
■
Cardiac dysrhythmias
■
Death
■
Endocarditis
■
Heart failure
■
Hemolysis
■
Hemolytic anemia
■
Hemorrhage, anticoagulant/antiplatelet-related
■
Leak, transvalvular or paravalvular
■
Myocardial infarction
■
Nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other)
■
Stroke
■
Structural deterioration (calcification, leaflet tear, stenosis, other)
■
Thromboembolism
■
Valve thrombosis
■
Infection other than endocarditis
It is possible that these complications could lead to:
■
Reoperation
■
Explantation
■
Permanent disability
■
Death
b
6. Instructions for use
6.1. Physician training
No specific training is required to implant Hancock II bioprostheses. The techniques for implanting these bioprostheses are
similar to those used for any stented bioprosthesis.
6.2. Device features
The stents are constructed from a polymeric material.
The inflow aspects of the aortic and mitral bioprostheses approximate the natural anatomy of the respective annuli. The aortic
bioprosthesis stent and sewing ring are scalloped, whereas the mitral bioprosthesis stent and sewing ring are flat.
The stents are covered with polyester fabric. The mitral bioprosthesis sewing ring contains polyester felt. The aortic
bioprosthesis sewing ring is scalloped to enable implantation either within the annulus or in the supra-annular position. The
aortic sewing ring is mounted flush with the inflow edge of the stent. If the supra-annular position is preferred, the entire
bioprosthesis can be seated supra-annularly allowing the use of a larger aortic bioprosthesis in the patient with a small aortic
annulus.
Instructions for Use English 11
Disposable Cinch holders are sutured to both aortic and mitral bioprostheses. These holders incorporate a ratchet mechanism,
which, after screwing the bioprosthesis holder onto the handle, is actuated by further handle rotation. This then causes the
stent posts to be drawn inward, easing bioprosthesis implantation. In the case of the mitral bioprosthesis, the suture attaching
the bioprosthesis holder prevents looping of the surgeon’s sutures during implantation.
The disposable holders are designed to fit the reusable Medtronic valve handle, Model 7639. Each handle is also used with the
Hancock II obturators for measuring the annulus. Both the aortic and mitral bioprostheses’ stents are fitted with annular rings
and stent post markers for radiographic visualization. The stent post markers are placed close to the apex of each stent post to
enable visualization of the proximity to the aortic and ventricular walls.
6.3. Handling and preparation instructions
Proper bioprosthesis size selection is an important part of heart valve replacement. The size selection of a Hancock II
bioprosthesis is aided by the use of the appropriate aortic sizer, aortic obturator, or mitral obturator. Refer to the Accessories
section in this Instructions for Use for sizer and obturator product names and models.
Within the sterile operative field, prepare 2 rinse basins, each containing 500 mL of sterile normal saline solution.
The exterior of the device container and lid are nonsterile. Examine the tamper strips to verify that the container has not been
damaged or previously opened. Do not use if all the tamper strips are damaged. Turn the lid counterclockwise and open the
container (Figure 1).
The bioprosthesis and all packaging components inside the container are sterile and must be handled accordingly. With the
thumb and index finger, grasp the retainer and slowly lift it out of the container allowing for drainage of the glutaraldehyde
storage solution (Figure 2).
Verify that the serial number on the retainer matches that of the container lid, shelf carton, and Patient Registration Form.
Record the serial number of the bioprosthesis in the patient’s record using the stickers provided on the Patient Registration
Form.
Hold the retainer upright. Remove the retainer cap by turning it counterclockwise using the thumb and index finger (Figure 3).
The Cinch holder will be visible.
While grasping the retainer, insert a sterile Medtronic valve handle into the Cinch holder. To secure the handle, rotate the
handle clockwise into the threaded opening of the holder until resistance is felt. Stop rotation if a first click is heard (Figure 4).
Caution: Do not overtighten the handle, as this will actuate the ratchet mechanism.
Remove the bioprosthesis from the retainer by pulling upward on the handle (Figure 5).
6.4. Rinse procedure
Using the Medtronic valve handle, continually agitate the entire bioprosthesis and holder for a minimum of 15 seconds in each
of the 2 previously prepared rinse basins (Figure 5). In each basin, gently squeeze the sewing ring to remove any residual
glutaraldehyde. Do not touch the tissue portion of the bioprosthesis. The bioprosthesis should remain in the second rinse
basin until needed for implantation.
6.5. Device implantation Caution: Do not use if the valve has been damaged. Caution: Extreme care must be taken to prevent damage to the delicate valve tissue. Do not handle the tissue portion of the
bioprosthesis with instruments. Even the most minor perforation may enlarge in time to produce significant impairment of valve
function. Should a bioprosthesis be damaged during insertion, do not attempt repair.
Caution: Do not use cutting needles, as they may cause structural damage to the fabric of the bioprosthesis.
Caution: Passage of a catheter through any bioprosthesis may damage the delicate valve tissue and is, therefore, not
recommended.
Aortic bioprosthesis
Caution: Orient the bioprosthesis to avoid obstruction of the coronary ostia.
Stent deflection is accomplished by lightly grasping the sewing ring of the bioprosthesis and rotating the handle clockwise
(Figure 6). The aortic holder, shown in a nondeflected state, is considered fully deflected when 2 of the 3 stent post tips are no
longer visible beneath the blue holder body when viewed from the outflow aspect (Figure 8 and Figure 9). Further deflection
does not provide increased ease of implant benefit. Do not deflect the stent posts past their fully deflected position. It is
recommended that valve stent deflection (cinching) be performed prior to lowering the valve into the aorta. Do not cinch the
valve stent posts for more than 30 minutes.
Caution: Suture used to deflect the stent posts may break if the handle is overtightened. If the holder suture breaks while
cinching the valve stent posts, inspect the valve stent for remnants of suture after removal of the Cinch® holder. If suture
remnants are present, remove them prior to completion of the valve implantation.
12 Instructions for Use English
During implantation, periodically irrigate the bioprosthesis with sterile saline to prevent drying delicate valve tissue. Following
placement of the sutures in the sewing ring, positioning of the valve in the annulus, and tying of all knots, release the holder by
cutting the holder sutures (Figure 7).
Hold the bioprosthesis in place and gently remove the holder and holder sutures. Examine the valve sewing ring, the valve
stent posts, and the valve holder to ensure that there are no holder suture remnants with the bioprosthesis. If suture remnants
are present, remove them prior to completion of the valve implantation. The holder should be detached from the handle and
discarded.
Mitral bioprosthesis
Actuate the ratchet mechanism of the holder by lightly grasping the sewing ring of the bioprosthesis and rotating the handle
clockwise (Figure 10). The stent posts are thus deflected inward to facilitate insertion of the bioprosthesis into the patient’s
annulus. The mitral holder, shown in a nondeflected state, is considered fully deflected when a gap of 1 to 2 mm exists between
any 2 of the 3 stent posts when viewed from the outflow aspect (Figure 12 and Figure 13). Further deflection does not provide
increased ease of implant benefit. Do not deflect the stent posts past their fully deflected position.
Caution: Suture used to deflect the stent posts may break if the handle is overtightened. If the holder suture breaks while
cinching the valve stent posts, inspect the valve stent for remnants of suture after removal of the holder. If suture remnants are
present, remove them prior to completion of the valve implantation.
Caution: If the bioprosthesis is implanted with broken holder suture(s), looping of the surgeon’s suture(s) around the stent
posts may occur, causing damage and significant impairment to bioprosthetic function.
Caution: Use of the mitral bioprosthesis in patients with a small left ventricle may result in perforation of the ventricular wall by
the stent posts.
Caution: To avoid potential stent post obstruction in the left ventricular outflow tract, the bioprosthesis should be oriented in the
mitral annulus so that the widest intercommissural space coincides with the patient's left ventricular outflow tract.
Viewed from the inflow aspect of the valve sewing flange, the widest intercommissural space of the bioprosthesis lies between
the green suture marker and the first commissure post in the counterclockwise direction. Orienting the bioprosthesis in the
annulus such that the green suture marker is directed approximately towards the right fibrous trigone should position the widest
intercommissural space appropriately. Verify proper positioning by examining stent post orientation in the ventricle before tying
off implantation sutures (Figure 14).
During implantation, periodically irrigate the bioprosthesis with sterile normal saline to prevent drying delicate valve tissue.
Following placement of the sutures, the bioprosthesis should be lowered into the annulus, taking care to prevent suture
entanglement. Maintaining tension on the sutures at this point is helpful.
Following placement of the bioprosthesis in the annulus, the holder should be removed by cutting the 3 holder sutures with
scissors or scalpel (Figure 11).
After cutting the 3 sutures, hold the bioprosthesis in place while gently pulling away the handle with the holder attached.
Examine the valve sewing ring, the valve stent posts, and the valve holder to ensure that there are no holder suture remnants
with the bioprosthesis. If suture remnants are present, remove them prior to completion of the valve implantation. The holder
should be detached from the handle, inspected, and discarded.
7. Clinical studies
The safety endpoints captured in the studies were complications, and the effectiveness endpoints were New York Heart
Association (NYHA) functional classification and echocardiographic assessments. Also captured were patient demographics.
These are presented in the tables below.
Table 8. Patient Demographics
Medtronic Long-Term AVR Clinical Study (N=267)
Age at implant in years (mean ± SD, [min., max.]) 64 ± 14, [17, 86]
Gender (% male/ % female) 79% / 21%
Etiology
Stenosis—% of pts. with stenosis alone (% [number in subgroup/N])
Insufficiency—% of pts. with insufficiency alone (% [number
in subgroup/N])
Mixed—% of pts. with stenosis and insufficiency (% [number
in subgroup/N])
Medtronic Long-Term MVR Clinical Study (N=102)
Age at implant in years (mean ± SD, [min., max.]) 63 ± 11, [26, 85]
Gender (% male/ % female) 52% / 48%
58% (154/267)
23% (62/267)
19% (51/267)
Instructions for Use English 13
Medtronic Long-Term MVR Clinical Study (N=102)
Etiology
Stenosis—% of pts. with stenosis alone (% [number in subgroup/N])
Insufficiency—% of pts. with insufficiency alone (% [number
in subgroup/N])
Mixed—% of pts. with stenosis and insufficiency (% [number
in subgroup/N])
Toronto Case Series AVR (N=710)
Age at implant in years (mean ± SD, [min., max.]) 65 ± 12, [18, 86]
Gender (% male/ % female) 75% / 25%
Etiology
Stenosis—% of pts. with stenosis alone (% [number in subgroup/N])
Insufficiency—% of pts. with insufficiency alone (% [number
in subgroup/N])
Mixed—% of pts. with stenosis and insufficiency (% [number
in subgroup/N])
Unknown <1% (4/710)
Toronto Case Series MVR (N=308)
Age at implant in years (mean ± SD, [min., max.]) 65 ± 11, [22, 86]
Gender (% male/ % female) 44% / 57%
Etiology
Stenosis—% of pts. with stenosis alone (% [number in subgroup/N])
Insufficiency—% of pts. with insufficiency alone (% [number
in subgroup/N])
Mixed—% of pts. with stenosis and insufficiency (% [number
in subgroup/N])
Unknown <1% (2/308)
Table 9. Effectiveness Outcomes, Functional NYHA
21% (21/102)
65% (66/102)
15% (15/102)
46% (325/710)
24% (170/710)
30% (211/710)
19% (59/308)
61% (188/308)
19% (59/308)
NYHA Class Preoperative Latest
n/N % n/N %
Medtronic Long-Term AVR Clinical Study (N=267)
I 5/267 2% 131/257 51%
II 55/267 21% 50/257 20%
III 169/267 63% 24/257 9%
IV 37/267 14% 9/257 4%
Unknown 1/267 <1% 43/257 17%
Medtronic Long-Term MVR Clinical Study (N=102)
I 0/102 0% 33/90 37%
II 11/102 11% 20/90 22%
III 71/102 70% 17/90 19%
IV 18/102 18% 5/90 6%
Unknown 2/102 2% 15/90 17%
Toronto Case Series AVR (N=710)
I 19/710 3% 294/489 60%
II 163/710 23% 135/489 28%
III 306/710 43% 58/489 12%
IV 222/710 31% 2/489 <1%
Unknown 0/710 0% 0/489 0%
Toronto Case Series MVR (N=308)
I 6/308 2% 70/172 41%
II 22/308 7% 66/172 38%
14 Instructions for Use English
NYHA Class Preoperative Latest
n/N % n/N %
III 126/308 41% 35/172 20%
IV 154/308 50% 1/172 1%
Unknown 0/308 0% 0/172 0%
Note: Latest assessment in the Medtronic Long-Term Clinical Study ranged from 1984 through 1996. Latest assessment in the
Toronto Case Series was in 1996.
Table 10. Effectiveness Outcomes, Toronto Case Series, Hemodynamics Aortic Valve Replacement
Valvular Regurgitation % (n/N)
0 (none) 77% (158/205)
1+ (trace/trivial/mild) 15% (31/205)
2+ (mild/moderate) 2% (4/205)
3+ (moderate/severe) 0% (0/205)
4+ (severe) 0% (0/205)
Unknown 6% (12/205)
Mean Pressure Gradient (mm Hg) Number in subgroup/N, mean ± SD [min., max.]
21 mm 9/13, 12.9 ± 4.2 [6.0, 19.2]
23 mm 47/53, 13.2 ± 4.6 [4.8, 26.1]
25 mm 50/60, 11.3 ± 4.4 [2.1, 26.0]
27 mm 48/57, 11.7 ± 4.8 [4.0, 24.0]
29 mm 19/22, 10.5 ± 3.6 [5.3, 19.2]
Note: Studies performed on 205 patients through 5 years postoperatively. Data not available for 32 patients.
Effective Orifice Area (cm2)
21 mm 11/13, 1.4 ± 0.5 [0.8, 2.4]
23 mm 48/53, 1.3 ± 0.2 [0.9, 1.9]
25 mm 50/60, 1.4 ± 0.3 [0.9, 2.3]
27 mm 47/57, 1.6 ± 0.4 [0.9, 2.5]
29 mm 19/22, 1.4 ± 0.3 [1.0, 2.3]
Note: Studies performed on 205 patients through 5 years postoperatively. Data not available for 30 patients.
Table 11. Effectiveness Outcomes, Toronto Case Series, Hemodynamics Mitral Valve Replacement
Valvular Regurgitation % (n/N)
0 (none) 71% (92/130)
1+ (trace/trivial/mild) 22% (29/130)
2+ (mild/moderate) 2% (3/130)
3+ (moderate/severe) 0% (0/130)
4+ (severe) 0% (0/130)
Unknown 5% (6/130)
Mean Pressure Gradient (mm Hg) Number in subgroup/N, mean ± SD [min., max.]
25 mm 0/2
27 mm 8/25, 4.5 ± 2.5 [2.3, 10.0]
29 mm 8/33, 4.1 ± 1.6 [2.0, 6.0]
31 mm 8/55, 3.8 ± 1.8 [2.0, 6.0]
33 mm 1/15, 3.0 [3.0, 3.0]
Note: Studies performed on 130 patients through 5 years postoperatively. Data not available on 105 patients.
Number in subgroup/N, mean ± SD [min., max.]
Effective Orifice Area (cm2)
25 mm 1/2, 4.5 [4.5, 4.5]
27 mm 20/25, 2.5 ± 0.8 [1.2, 4.6]
29 mm 33/33, 2.7 ± 0.6 [1.4, 4.2]
31 mm 49/55, 2.6 ± 0.7 [1.2, 5.0]
33 mm 15/15, 3.0 ± 0.9 [1.0, 4.4]
Note: Studies performed on 130 patients through 5 years postoperatively. Data not available for 12 patients.
Number in subgroup/N, mean ± SD [min., max.]
Instructions for Use English 15
8. Individualization of treatment
Long-term anticoagulant and/or antiplatelet therapy should be considered for patients with a dilated left atrium, a history of
thromboembolic events, or a cardiac rhythm of atrial fibrillation or atrial flutter.
8.1. Specific patient populations
The safety and effectiveness of the Hancock II bioprosthesis 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)
■
Children, adolescents, or young adults
9. 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 (eg, 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.
10. How supplied
10.1. Packaging
The Hancock II bioprosthesis is chemically sterilized and is supplied sterile in a buffered 0.2% glutaraldehyde storage solution.
Sterility is compromised if the glass jar and lid container is opened and/or damaged. The outside of the container is not sterile
and should not be placed in the sterile field.
10.2. Storage
The Hancock II bioprosthesis must be stored between 5°C and 25°C (41°F and 77°F). Refrigeration is not required, and
freezing may damage the bioprosthesis. Room temperature storage up to 25°C (77°F) is satisfactory provided the bioprosthesis
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 bioprostheses with earlier Use-by dates are preferentially implanted
and expiration is avoided.
10.3. Return of explanted bioprostheses
Medtronic is interested in obtaining recovered Hancock II bioprostheses. 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.
11. Patient information
11.1. 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 package and on the identification tag attached to the retainer. 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.
11.2. Patient manual
Medtronic has prepared a Patient Information Pamphlet that the physician should provide to the patient prior to discharge.
Copies of these pamphlets may be obtained from a Medtronic sales representative.
12. Postoperative information
12.1. MRI safety information
Nonclinical testing has demonstrated the Hancock II bioprosthesis is MR Conditional. A patient with this device can be safely
scanned immediately after implantation in an MR system meeting the following conditions:
16 Instructions for Use English
■
Static magnetic field of 1.5 T or 3 T
■
Maximum spatial field gradient of 2500 gauss/cm or less
■
Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the Hancock II bioprosthesis is expected to produce a maximum temperature rise of
less than 2.1°C after 15 minutes of continuous scanning.
In nonclinical testing, the image artifact caused by the device extends approximately 20 mm from the Hancock II bioprosthesis
when imaged with a gradient echo pulse sequence and 3T MRI system.
13. Accessories
Use the sizers or obturators specified below to determine the appropriate size Hancock II bioprosthesis.
■
Hancock II Ultra™ Supra-X aortic sizers, Model 7505UX
■
Hancock II™ aortic obturators, Model 7505
■
Hancock II™ mitral obturators, Model 7510
■
Medtronic valve handle, Model 7639
■
Medtronic lock nut, Model 7642
Caution: Do not use other manufacturers’ valve sizers/obturators, or sizers/obturators for another Medtronic prosthesis, to size
the Hancock II bioprosthesis.
Caution: Do not use the accessories until they have been thoroughly cleaned and sterilized. Refer to the appropriate
Instructions for Use for further instructions.
14. Disclaimer of warranty
THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES CUSTOMERS ONLY:
ALTHOUGH THE HANCOCK II BIOPROSTHESES, MODELS T505 AND T510, 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.
Instructions for Use English 17
Medtronic, Inc.
*1220014001*
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
LifeLine Technical Support, 24-hour consultation service:
1 877 526 7890
Medtronic Heart Valves Division
1851 E. Deere Avenue
Santa Ana, CA 92705
USA
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Canada
Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
1 800 268 5346
© 2004-2018 Medtronic
1220014001 Rev. 1C
2018-06-12
Loading...