PROVOX Vega Manual De Instrucciones página 10

Aspiration of the prosthesis – Accidental aspiration of the voice prosthesis or other components
of the voice rehabilitation system may occur. As with any other foreign body, complications from
aspiration of a component may cause obstruction or infection. Immediate symptoms may include
coughing, wheezing or other abnormal breathing sounds, dyspnea, and respiratory arrest, partial or
inadequate air exchange and/or asymmetrical chest movement with respiration. Complications may
include pneumonia, atelectasis, bronchitis, lung abscess, bronchopulmonary fistula and asthma.
If the patient can breathe, coughing may remove the foreign body. Partial airway obstruction or
complete airway obstruction requires immediate intervention for removal of the object. If aspiration
of the device is suspected, a CT scan of the lungs should be performed to confirm aspiration and
locate the device. If the CT scan confirms aspiration of the device, the device may be retrieved
endoscopically using a non-toothed grasping forceps.
The silicone housing of the Vega voice prosthesis can also be located endoscopically. On a CT scan
and during endoscopy, the device may appear as a oval shape with an opening in the middle with an
outer diameter of about 10-17 mm (the flanges of the device), or as a cufflink shape with a shaft length
of 8, 10, 12.5 or 15 mm, depending on the size of the device. During endoscopy, reflections from the
light source on the clear silicone rubber may be seen. Also, in prostheses that have been in situ for
some time, white or yellow appearing Candida deposits may be visible on the device.
Ingestion of the prosthesis – Accidental ingestion of the voice prosthesis, or other components of
the voice rehabilitation system, may occur. As with any other foreign body, the symptoms caused by
ingestion of the prosthesis or a component of the voice rehabilitation system depends largely on size,
location, degree of obstruction (if any) and the length of time it has been present. Ingested components
that have remained in the lower esophagus may be removed by esophagoscopy or observed for a short
period of time. The object may pass spontaneously into the stomach. Foreign bodies that pass into
the stomach usually pass through the intestinal tract. Surgical removal of foreign bodies from the
intestinal tract must be considered when bowel obstruction occurs, bleeding is present, perforation
occurs or the object fails to pass through the intestinal tract.
Spontaneous passage of the device may be awaited for 4-6 days. The patient should be instructed
to observe the stools for the ingested device. If the device does not pass spontaneously, or if there
are signs of obstruction (fever, vomiting, abdominal pain) a gastroenterologist should be consulted.
The silicone housing of the Vega voice prosthesis can be located and retrieved endoscopically. The
device may be retrieved by using a non toothed grasping forceps. During endoscopy, the device may
appear as a oval shape with an opening in the middle with an outer diameter of about 10-17 mm (the
flanges of the device), or as a cufflink shape with a shaft length of 8, 10, 12.5 or 15 mm, depending
on the size of the device. Reflections from the light source on the clear silicone rubber may be seen.
In prostheses that have been in situ for some time, white or yellow appearing Candida deposits may
be visible on the device.
Infection and/or edema of the TE-puncture – Infection, granulation formation and/or edema of the
puncture may increase the length of the puncture tract. This may cause the prosthesis to be drawn
inward and under the tracheal or esophageal mucosa. Inflammation or overgrowth of the esophageal
mucosa may also cause the prosthesis to protrude from the puncture. Temporary replacement of the
prosthesis by a prosthesis with a longer shaft is then advisable. If standard medical treatment does
not resolve the infection, the prosthesis should be removed. In some cases stenting the puncture with
a catheter might be considered. If the puncture closes spontaneously re-puncture for insertion of a
new prosthesis may be required.
Granulation around the puncture – Formation of granulation tissue around the TE-puncture has
been reported at an incidence of about 5%. Electrical, chemical, or laser cauterization of the area of
granulation may be considered.
Granulation/Hypertrophic scarring around the puncture – Bulging of the tracheal mucosa over
the tracheal flange may occur if the prosthesis is relatively short. This excess tissue may be removed
by using a laser. Alternatively, a prosthesis with a longer shaft can be used.
Protrusion/extrusion of the prosthesis – Protrusion of the prosthesis and subsequent spontaneous
extrusion is sometimes observed during infection of the TE-puncture. Removal of the prosthesis is
required to avoid dislodgement into the trachea. The puncture may close spontaneously secondary
to the removal of the prosthesis. Re-puncture may be necessary for insertion of a new prosthesis.
Tissue damage – If the prosthesis is too short, too long, or is pushed frequently against the esophageal
wall by a laryngectomy tube, stoma button, or the patients' finger, damage of the puncture, tracheal
and/or esophageal tissues may occur. Inspect the conditions regularly to avoid severe damage.
Leakage through the valve – Leakage through the prosthesis may occur because:
• Candida overgrowth near the valve seat and valve flap may lead to incomplete closure of the
valve flap, which causes leakage through the device. This is a normal event in prosthetic voice
rehabilitation and an indication to replace the voice prosthesis.
• Stronger negative pressure in the PE-segment occurs during swallowing. To investigate this,
transstomal inspection of the valve flap of the prosthesis should be performed during swallowing.
Leakage around the prosthesis – Transient leakage around the prosthesis may occur and may resolve
spontaneously. The most common reason is that the prosthesis is too long, which is solved by inserting
a shorter prosthesis. If the problem is not solved by inserting the correct length prosthesis, other
factors that may affect tissue integrity in the area of the TE puncture (for example gastroesophageal
reflux or thyroid function) should be considered, evaluated, and treated. In enlarged punctures with
reduced retention strength other conventional treatment methods such as the injection of fillers
(e.g., collagen) or temporary removal of the voice prosthesis, should be considered. If the leakage
around the voice prosthesis is intractable, more conservative measures, such as surgical closure of
the puncture may be necessary.
2. Instructions for use
Please see accompanying Illustration manual for illustrations referenced in this Instructions
for Use.
For a visual overview of the different procedures you can find links to video animations under the
section headings below.
Caution: The videos do not replace nor do they set forth the complete contents of the Instructions
for Use and /or Prescriber Information, and are not a substitute for reviewing the entire contents of
the Instructions for Use. The videos are only intended to further enhance the understanding of the
procedure after review of the Instructions for Use.
2.1 Preparation
Prior to the puncture always determine what size and diameter of voice prosthesis to use. The appropriate
size and diameter depends on the anatomy of the patient, local medical practice and preference of
the surgeon.
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