Patient Counseling Information; Potential Adverse Events - Medtronic Open Pivot Gebrauchsanweisung

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DO NOT use the device if the conduit appears to be wet.
4.2. Precautions
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The outer carton label serves as a tamper evident package seal. After removing the double barrier
containers from the shipping package, examine them carefully to verify that the seals and containers are
intact. If any seal is damaged or missing, do not use the device. If the Use By date has expired, the
device should not be used.
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If surgical technique requires cross-clamping of the graft, use atraumatic clamps.
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It is suggested that only taper point needles be used for suturing the graft as taper cut or other cutting
needles may cut the graft fibers.
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Avoid excessive tension on the prosthesis. Gently extend the graft until the crimps are flat.
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If the AVG conduit material needs to be cut, it should be cut with a cautery to prevent unraveling. Use of
a high temperature cautery may cause ignition of dry graft material. To minimize this potential, the graft
material may be moistened and kept moist.
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It is suggested that fibrin glue be used to seal cuff suture line and coronary anastomosis.
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Store in a cool, dry location.

4.3. Patient Counseling Information

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Patients with prosthetic valves who undergo dental or potentially bacteremic procedures should receive
antibiotic prophylaxis.
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All mechanical prosthetic heart valves produce sound as a function of their operation. Patients should
be advised of this prior to implantation.
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Patients should be encouraged to carry the Implanted Device Identification Card, provided by Medtronic,
with them at all times.

5. Potential Adverse Events

Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited
to:
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angina
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cardiac arrhythmia
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endocarditis
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hemolysis
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hemolytic anemia
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hemorrhage, anticoagulation-related
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myocardial infarction
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leaflet entrapment (impingement)
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nonstructural dysfunction
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pannus
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perivalvular leak
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transvalvular regurgitation
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structural dysfunction
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thrombosis
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stroke
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thromboembolism
Adverse events potentially associated with the use of vascular grafts include, but are not limited to:
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aneurysm
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collagen has been shown to be a weak immunogen; clinical reactions to collagen implantation have been
described as infrequent, mild, localized, and self limiting
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embolism
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hemorrhage
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infection
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occlusion (including thrombosis and anastomotic intimal hyperplasia)
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pseudoaneurysm
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seroma
It is possible that these complications could lead to:
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reoperation
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explantation
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permanent disability
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heart failure
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death
6. Instructions for Use
6.1. Sterilization Information
The AVG and package contents have been sterilized using irradiation. The AVG is ready for use when
received. Do not use if:
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the Use By date has expired
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the container (inner packaging) is damaged
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the sterility barrier is broken
8 Instructions for Use English