Contraindications; Warnings And Precautions - Medtronic Open Pivot Gebrauchsanweisung

Aneurysm
Pseudoaneurysm
NO ADVERSE EVENTS RELATED TO THE TEST ARTICLE WERE REPORTED.
Actuarial survival rate
Actuarial graft patency rate
2
Bleeding
Thrombosis
Embolism
Graft Infection
Aneurysm
Pseudoaneurysm
NO ADVERSE EVENTS RELATED TO THE TEST ARTICLE WERE REPORTED.
Results of several studies of knitted Hemashield grafts, both short-term and up to 5 years, have been reported
3, 4, 5, 6, 7, 8
in the literature.
long-term, of the sealant used in the Hemashield graft.
2. Indications for Use
The AVG is intended for use secondary to a diseased, damaged, or malfunctioning aortic valve with aortic
aneurysmal or occlusive disease where a replacement valve and replacement or repair of the aorta is
required. This device may be used to replace a previously implanted prosthetic heart valve and conduit.

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.
Warning: This valved conduit should not be implanted in patients with a known sensitivity to products of
bovine origin.

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.
■
Use only Medtronic valve holders, sizers, rotator, and leaflet actuator.
■
Leaflet motion must be tested only with the green leaflet actuator supplied with the AVG device or the
blue leaflet actuator supplied with the sizer set. DO NOT test leaflet motion or touch the valve with metal
instruments.
■
Never pass a catheter or instrument through the valve.
■
DO NOT handle the valve except with accessories provided by Medtronic. Contact with the valve by any
other instruments may cause damage to the leaflets and orifice or result in imperfections in blood contact
areas. Scratching the surface may lead to a loss of structural integrity.
■
When securing the valve in place, suture needles should be passed through the outer third of the sewing
cuff and suture ends cut short after the knots are tied.
■
Force should never be applied to the valve leaflets.
■
Before making the aortic anastomosis, test the value for free leaflet motion with the green leaflet actuator
supplied with the AVG device or the blue leaflet actuator. Rotating the valve may help to avoid abnormal
residual subvalvular pathology which could interfere with leaflet motions.
■
DO NOT PRECLOT. With the Hemashield Woven Double Velour Vascular Graft treatment, preclotting
is not 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 122°F (50°C).
2 Nongraft bleeding source was identified for all test group bleeding events.
3 Canadian Multicenter Hemashield Study Group. Immunologic response to collagen-impregnated vascular grafts: a
randomized prospective study. J Vasc Surg 1990; 6:741-746.
4 Freischlag JA, Moore WS. Clinical experience with a collagen-impregnated knitted Dacron vascular graft. Ann Vasc Surg
1990; 4:449-454.
5
Hirt SW, Dosis D, Siclari R, et al. Collagen-presealed or uncoated aortic bifurcation Dacron prostheses: A 5-year clinical
follow-up study. Thorac Cardiovasc Surgeon 1991; 39:365-370.
6 Riegel MM, Hollier LH, Pairolero, Hallett JW. Early experience with a new collagen-impregnated aortic graft. AM Surgeon
1988; 54:134-136.
7 de Mol van Otterloo JCA, van Bockel JH, Ponfoort ED, et al. Randomized study on the effect of collagen impregnation of
knitted Dacron velour aortoiliac prostheses on blood loss during aortic reconstruction. Br J Surg 1991; 78:288-292.
8 de Mol van Otterloo JCA, van Bockel JH, Ponfoort ED, et al. The effects of aortic reconstruction and collagen impregnation
of Dacron prostheses on the complement system. J Vasc Surg 1992; 16:774-783.
Double Velour Vascular Graft
0 (0%)
0 (0%)
Table 3. ABDOMINAL/PERIPHERAL–1 YEAR RESULTS
N=51
96%
98%
Adverse Events - Actuarial Rates
1 (2%)
1 (2%)
3 (6%)
0 (0%)
0 (0%)
0 (0%)
These studies support the high patency and nonantigenic nature, both short and
Hemashield Woven
Hemashield Woven
Double Velour Vascular Graft
Control Graft
0 (0%)
0 (0%)
Control Graft
N=51
86%
100%
0 (0%)
0 (0%)
2 (4%)
0 (0%)
0 (0%)
0 (0%)
Instructions for Use English 7