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10.
ADVERSE EVENTS
It is important to discuss all possible adverse events with
your patient. Adverse events that may result from the use of
this product include the risks associated with the
medications and methods utilized in the endoscopic
procedure, the risks associated with any endoscopic
procedure, the risks associated with the IGB specifically,
and the risks associated with the patient's degree of
intolerance to a foreign object placed in the stomach.
NOTE: Any serious incident that has occurred in relation to
the device should be reported to Apollo Endosurgery (see
contact information at the end of this document) and any
appropriate government entity.
10.1
Possible Adverse Events
Possible adverse events associated with the use of the IGB
include:
•
Death due to complications related to aspiration,
intestinal obstruction, gastric perforation, or esophageal
perforation, is possible.
Intestinal obstruction by the IGB. An insufficiently filled
•
IGB or a leaking IGB that has lost sufficient volume may
be able to pass from the stomach into the small bowel.
It may pass all the way into the colon and be passed
with stool. However, if there is a narrow area in the
bowel or adhesion formation, which may occur after
previous surgery on the bowel, the IGB may not pass
and could cause a bowel obstruction. If this occurs,
surgery or endoscopic removal could be required.
Esophageal obstruction. When the IGB is being filled in
•
the stomach, the IGB could be inadvertently pulled back
into the esophagus. If this occurs, surgery or
endoscopic removal could be required.
•
Gastric outlet obstruction. A partially filled IGB (i.e.,
<400cc), or a leaking IGB could lead to gastric outlet
obstruction, requiring IGB removal. It is also possible for
a fully filled (400-700cc) IGB to impair the gastric outlet,
which can produce a mechanical impediment to gastric
emptying. Gastric outlet obstruction may require early
removal.
Gastric distention with retained food and fluid due to
•
severely delayed gastric emptying with or without outlet
obstruction from displacement of the IGB into the
antrum.
Injury to the digestive tract during placement of the IGB
•
in an improper location such as in the esophagus or
duodenum. This could cause bleeding and perforation,
which could require a surgical or endoscopic correction
for control.
Insufficient or no weight loss.
•
Adverse health consequences resulting from weight
•
loss.
Gastric discomfort, feelings of nausea and vomiting
•
following IGB placement as the digestive system
adjusts to the presence of the IGB.
•
Continuing nausea and vomiting. This could result from
direct irritation of the lining of the stomach, delayed
gastric emptying and/or the IGB blocking the outlet of
the stomach. It is even theoretically possible that the
IGB could prevent vomiting (not nausea or retching) by
blocking the inlet to the stomach from the esophagus.
A feeling of heaviness in the abdomen.
•
•
Abdominal or back pain, either steady or cyclic.
Gastroesophageal reflux.
•
•
Influence on digestion of food.
Blockage of food entering into the stomach.
•
•
Bacterial growth in the fluid which fills the IGB. Rapid
release of this fluid into the intestine could cause
infection, fever, cramps and diarrhea.
Injury to the lining of the digestive tract as a result of
•
direct contact with the endoscope, the IGB, grasping
forceps, or as a result of increased acid production by
the stomach. This could lead to ulcer formation with
pain, bleeding or even perforation. Surgery could be
necessary to correct this condition.
IGB
deflation
•
replacement.
•
Acute pancreatitis.
Spontaneous hyperinflation due to gas production
•
within the IGB.
10.2
POSSIBLE
COMPLICATIONS
ENDOSCOPY & SEDATION
Potential
risks
procedures include, but are not limited to: abdominal
cramping and discomfort if air is used to distend the
stomach, sore or irritated throat, bleeding, infection, tearing
of the esophagus or stomach that could lead to perforation,
and aspiration pneumonia. The risk increases if additional
procedures are performed.
According to the American College of Gastroenterology,
risks related to sedation during endoscopic procedures are
rare, occurring in less than one in every 10,000 people.
most common complications involve a temporary decrease
in the rate of breathing or heart rate, which can be corrected
by giving extra oxygen or by reversing the effect of the
sedative medications. Patients with heart, lung, kidney, liver,
or other chronic diseases are at higher risk for complications.
Drug dosages and airway management should be taken into
consideration when treating high risk patients.
11.
HOW SUPPLIED
Each IGB System contains an IGB positioned within a
"Placement Catheter Assembly" and a "Fill Kit". All are
supplied NONSTERILE and FOR SINGLE USE ONLY. All
components should be handled carefully.
Materials Included:
One (1) Intragastric Balloon (IGB) System consisting of:
•
o One (1) Placement Catheter Assembly (i.e. Sheath
Assembly) containing the IGB
o One (1) Fill Kit with IV Spike
Materials Not Included:
Endoscope
•
•
Surgical Gel
Sterile Saline
•
•
Sterile 50cc Syringe
Removal tools (i.e. sheathed needle catheter, long jaw
•
or wire prong grasper)
7
(i.e.
collapse)
and
OF
associated
with
upper
subsequent
ROUTINE
endoscopic
1
The
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