6
•
DO
support the TE tissue during dilatation. Otherwise, rupture may occur. In case of a rupture of
the TE tissue the TE puncture procedure should be abandoned and the rupture should be sutured
immediately. TE puncture should only be repeated after proper healing of the tissues.
•
DO NOT
reload after the safety strap of the prosthesis has been cut off, as the safety mechanism
in that case has been compromised, with risk for dislocation of the voice prosthesis during the
procedure.
1.6 Adverse events and troubleshooting information
1.6.1 During use of the Puncture Set
(Sub-) mucosal injury
During puncture, the Puncture Needle or the Guidewire could cause a (sub) mucosal injury if the
Pharynx Protector is not located in its correct position, or if the puncture is made incorrectly. In
case of suspicion of (sub)mucosal damage, it is recommended that the patient receives a prophylactic
course of postoperative antibiotics and is fed through a nasogastric tube or similar to allow healing.
Re-puncture
If the Pharynx Protector is not positioned appropriately when puncturing, or if, for any other reasons,
there is need for re-puncture, the tissue should be assessed for possible sub-mucosal injury and the
puncture procedure repeated with the Pharynx Protector positioned correctly.
Forgot to remove the Pharynx Protector
If the Puncture Dilator is connected to the Guidewire prior to removal of the Pharynx Protector, the
procedure cannot be completed. If this occurs, detach the Puncture Dilator from the Guidewire and
remove the Pharynx Protector. Also see Reloading below.
Reloading
In some cases, reloading of the Puncture Dilator may be necessary; e.g., if the voice prosthesis is
pulled completely through the puncture during prosthesis placement. The reloading procedure is
described in section 2.2.3 and illustrated in Fig. 4.
1.6.2 During use of the voice prosthesis
Dislodgement of the voice prosthesis
– Dislodgement can be caused by infection and/or edema of
the TE-puncture, granulation around the puncture or hypertrophic scarring around the puncture.
Dislodgement might lead to aspiration or ingestion of the prosthesis. See below.
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.
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