Adverse Events/Trouble Shooting Information - Atos Medical PROVOX Vega Bedienungsanleitung

Accessories to facilitate insertion of the prosthesis (for
clinician's use)
• Provox Dilator: Helps to convert from a prosthesis with a smaller
shaft diameter to a Provox voice prostheses of larger diameter.
• Provox GuideWire: for placement of a Provox, Provox2 or
Provox Vega voice prosthesis in a freshly made TE puncture, or for
retrograde replacement of a Provox indwelling voice prosthesis.
Accessories to maintain the device function (for patient's use)
• Provox Brush / Provox Brush XL is used by the patient to clean
the inside of the prosthesis.
• Provox Flush is an additional cleaning device that allows flushing
of the prosthesis.
• Provox Vega Plug is a First Aid tool for patient's use that
temporarily blocks leakage through the prosthesis.
Other supplementary products that can be used with
Provox voice prostheses.
• Provox HME: Heat- and Moisture Exchanger partially restores
lost nasal functions (heating, humidifying, breathing resistance).
• Provox FreeHands HME: A Heat and Moisture Exchanger
combined with an automatic tracheostoma valve, designed to allow
hands-free speech.
• Provox LaryTube: A silicone tracheal cannula intended to support
shrinking stomas while retaining other rehabilitation devices of the
Provox System.
• Provox LaryButton: A soft, self-retaining silicone tracheal
cannula intended to support shrinking stomas while retaining other
rehabilitation devices of the Provox System.
4. Adverse events/Trouble shooting
information
The following are possible risks associated with prosthetic voice
rehabilitation:
Prosthesis related
Leakage through the valve – Leakage through the prosthesis may
occur in association with Candida overgrowth of the valve flap or
dislodgement of the radio opaque ring (valve seat). It may also occur
if the esophageal flange of the prosthesis is not fully developed in the
lumen of the esophagus or if the prosthesis is too short. Endoscopic
examination should be performed to determine whether any of these
phenomena has occurred. If the prosthesis is in the correct position and
of the right length, and if cleaning of the prosthesis does not resolve
leakage through the prosthesis, replacement of the prosthesis is indicated.
Candida overgrowth – Candida overgrowth of the prosthesis occurs
in almost all patients. Radiotherapy, salivary content and dietary habits
may influence how rapidly Candida can affect the silicone material.
Treatment with antifungal agents may be considered as a preventive
measure if Candida overgrowth causes leakage through the prosthesis
or other incompetence of the valve.
Compatibility with antifungal medicine
An unknown variety of chemical substances may immediately influence
the material properties of the device or may be absorbed by the material
and subsequently released at a later time. Therefore, the introduction
of antifungal medicines or drugs directly to or within close proximity
of the voice prosthesis should be carefully assessed.
Laboratory tests show only minor negative influence on the function
of the Provox Vega voice prosthesis and components when using the
following antifungal medications:
• Nystatin
• Fluconazole
• Mikonazol
Puncture related
Aspiration of the prosthesis – Accidental aspiration of the voice
prosthesis or other components of the voice rehabilitation system
may occur. Immediate symptoms may include gagging, coughing,
choking or wheezing. As with any other foreign body, complications
from aspiration of a component may cause obstruction or infection.
Complications may include pneumonia, atelectasis, bronchitis, lung
abscess, bronchopulmonary fistula and asthma. If the patient can breathe,
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