Additional Information; Compatibility With Mri, X-Ray And Radiation Therapy; Device Lifetime; User Assistance Information - Atos Medical Provox Vega XtraSeal Manual Del Usuario

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 fi stula
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.
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 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 esophaguscopy 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 in 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.
Hemorrhage/Bleeding of the puncture – Slight bleeding from the edges of the TE-puncture
may occur during replacement of the prosthesis and generally resolves spontaneously.
Patients on anti-coagulant therapy, however, should be carefully evaluated for the risk
of hemorrhage prior to placement or replacement of the prosthesis.
Infection and/or edema of the TE-puncture –Infection, granulation formation and/or
edema of the puncture (e.g during radio therapy) may increase the length of the puncture
tract. This may cause the prosthesis to be drawn inward and under the tracheal or esophageal
mucosa. Or, infl ammation or overgrowth of the esophageal mucosa may cause the prosthesis
to protrude from the puncture. Temporary replacement of the prosthesis by a prosthesis
with a longer shaft is then advisable. Treatment with broad-spectrum antibiotics with or
without corticosteroids may be considered for treatment of the infection. If the infection
does not resolve with antibiotics and/or corticosteroid intervention in the presence of
the prosthesis, the prosthesis should be removed. In some cases stenting the puncture
with a catheter might be considered. If the puncture closes spontaneously secondary to
removal of the prosthesis, repuncture 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 5%. Electrical, chemical, or laser
cauterization of the area of granulation may be considered.
Hypertrophic scarring around the puncture – Bulging of the tracheal mucosa over
the tracheal fl ange may occur if the prosthesis is relatively short. This excess tissue may
be removed by using a laser (CO2, or NdYAG). 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. Repuncture may be
necessary for insertion of a new prosthesis.
Leakage around the prosthesis – Transient leakage around the prosthesis may occur
and may improve spontaneously. The most common reason is that the prosthesis is too
long, which is solved by inserting a shorter prosthesis. A prosthesis of another diameter
(upsizing) can also solve the leakage. It can also occur when the enlarged fl ange of the
Provox Vega XtraSeal has not deployed fully into the esophageal lumen. No part of the
enlarged esophageal fl ange should be visible alongside the shaft of the voice prosthesis
and when rotated the voice prosthesis should move freely. Rotating the voice prosthesis
while at the same time slightly pushing it towards the esophagus can help to unfold the
enlarged fl ange completely. In case of uncertainty, use fl exible endoscopy to confi rm
proper placement inside the esophagus.
If leakage does not improve (which it often does spontaneously), a Provox XtraFlange
can be used. Other methods to solve leakage around the voice prosthesis are temporary
removal of the prosthesis and the insertion of a cuffed tracheal cannula and/or nasogastric
feeding tube to permit shrinkage of the puncture. Alternatively, a purse string suture
with 3x0 absorbable material could be submucosally applied around the TE-puncture
after removal of the prosthesis. The new prosthesis should be inserted and the suture
should be tightened gently, enclosing the puncture walls around the prosthesis. If leakage
around the prosthesis is intractable, more conservative measures, surgical closure of the
puncture and subsequent re-puncture may be necessary.
Tissue damage – If the prosthesis is too short, too long, or is pushed frequently against
the esophageal wall by a tracheal cannula, stoma button, or the patients' fi nger, damage
of the puncture, tracheal and/or esophageal tissues may occur. In patients undergoing
radiotherapy this may happen more easily. Inspect the conditions regularly to avoid
severe damage.

5. Additional information

5.1 Compatibility with MRI, X-ray and radiation therapy

Provox voice prostheses have been tested and found to be compatible, except Provox
ActiValve, with Magnetic Resonance Imaging (tested up to 3.0 Tesla), x-ray and radiation
therapy (tested up to 70 Gy). The prosthesis can be left in the TE-puncture during the
examination/therapy session. Note that the radio-opaque valve seat is visible on x-ray.

5.2 Device lifetime

Depending on individual biological circumstances the device life varies, and it is not
possible to predict the integrity of the device over a longer period of time. The material
of the device will be affected by e.g. bacteria and yeast, and the structural integrity of
the device will eventually deteriorate.

5.3 User assistance information

For additional help or information, please see back cover of the Instructions for Use for
contact information.
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