Precautions During Use - Nvt Allegra Gebrauchsanweisung

12 | EN | Transcatheter Aortic Valve Implantation System TF
In the event of any non­matching information, do not use the product.
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Do not use the THV if the product jar is damaged or if the seal is broken or the outside of the
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product jar is wet.
Do not use the THV if the level of the liquid inside the product jar is below the 120 ml mark.
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Do not use the THV if there are any signs of damage to the tissue or frame.
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Do not use the delivery system if there are any signs of damage.
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5.2. PRECAUTIONS DURING USE
The outside of the product jar is not sterile and must not enter the sterile field.
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Follow aseptic techniques during device preparation and implantation.
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Any THV that is dropped, damaged, or mishandled in any way must not be used for implan­
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tation.
Do not handle or manipulate the THV with sharp or pointed objects.
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Do not touch or squeeze the THV during rinsing. No other objects should be placed in the
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rinsing bowls.
Make sure not to rinse the THV in an already used rinsing solution.
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Do not load the THV without protection wire.
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Avoid too many crimping cycles during loading.
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Make sure that the THV touches the catheter tip, otherwise the reference with the radiopaque
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ring will be wrong.
Check if the safety locker is locked and cannot be moved.
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If you feel any resistance during loading, the loading procedure must be stopped and the
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cause of the resistance evaluated.
Do not use any tool other than the loading pin, in order to prevent damage to the pericardium.
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Do not use any tool other than the loading pin, to press the struts inside.
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Make sure that the suture or particles from the heart valve holder do not remain inside the THV.
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Make sure that no parts of the tip funnel remain inside or on the catheter.
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Keep the THV hydrated and de-aired by flushing the port of the catheter shaft until ready
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for implantation.
In case of an implantation in a failing surgical bioprosthesis, carefully check the patient's anat­
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omy regarding low coronary artery location, especially in combination with shallow sinuses.
In case of an implantation in a failing surgical bioprosthesis, ensure that there is no partially
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detached valve leaflet, which can occlude a coronary ostium in the aortic position.
In case of an implantation in a failing surgical bioprosthesis, the risk of coronary occlusion is
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higher for surgical bioprostheses with external leaflets.
In case of an implantation in a failing surgical bioprosthesis, ensure that the guidewire is in
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the central lumen of the failing surgical bioprosthesis because paravalvular placement or
placement through a defect in the leaflet or the suture ring of the failing surgical bioprosthesis
will lead to complications.
Ensure the diameter of the access vessels is adequate.
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Do not kink the catheter shaft.
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Make sure that if you pre­bend the guidewire it will not be damaged.
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