Potential Adverse Events - GI Dynamics EndoBarrier Instrucciones De Uso

the liner. This should include observation of the
papilla and other accessory ducts. This examination
should be made to ensure that they are not located in
the bulbous duodenum.

Placement and removal of the GI liner requires the use
of fluoroscopic guidance. Only water soluble contrast
should be used. Gastrografin or equivalent is
recommended. Do not use barium. Caution should be
used to protect the patient's reproductive organs from
the effects of radiation.

An incorrectly positioned GI liner may interfere with
the bile duct or pylorus. Physicians should remove the
incorrectly positioned liner in these patients. Do not
attempt to drag or push the liner into position.
Additionally, the GI liner should be removed in any
patient with clinical and/or chemical evidence of a
biliary tract obstruction.

Do not leave GI liner in place with a crossed tip.
Crossed tips should be uncrossed by lifting them with
endoscopic forceps.
Post-procedural precautions
It is unknown if certain foods (such as grains and nuts)
could interfere with the proper functioning of the
gastrointestinal liner. Therefore, patients receiving the GI
liner will be placed on a diet regimen similar to that of a
Roux-en-Y gastric bypass patient.

Potential Adverse Events

As with all endoscopic and/or implant procedures, serious
r.
injury or death can occu
Potential complications during the placement
procedure may include:

GI tract laceration

Oropharyngeal perforation

Esophageal perforation

Gastric perforation

Bowel perforation

Bleeding - in rare cases, significant bleeding that may
result in surgery and/or transfusion

Aspiration

Infection with or without fever

Complications associated with endoscopic procedures
(i.e., sore throat or deep vein thrombosis)

Prolonged procedure time

Headache

Reaction to antibiotic use

Anchor across pylorus (misplacement)

Dizziness
Potential complications during the treatment
period may include:

Small bowel/GI liner obstruction

GI liner migration or rotation

Bezoar

Erosion

Bleeding - in rare cases, significant bleeding that may
result in surgery and/or transfusion

Vitamin and mineral deficiency

Dehydration - in rare cases, leading to compromised
renal function

Constipation

Bloating

Diarrhea

Infection with or without fever

Hepatic abscess

Pancreatitis (with or without bile duct blockage)

Gastroenteritis

Hypoglycemia

Hyperglycemia

Flatulence

GERD

Esophagitis

Pseudopolyps

Nausea/vomiting

GI pain/cramping

Peptic ulcer disease

Duodenitis

Gastric or bowel perforation

Local inflammatory tissue reaction

Flank/back pain

Alopecia

Intestinal intessuseption

Headache

Biliary disease/cholelithiasis

Hypotension

Hypertension

Serum chemistry changes

Adhesions

Abdominal pain

Concurrent Illness

Weakness (due to diet)

Patient intolerance
Potential complications during and after GI
liner removal may include

GI tract laceration

Oropharyngeal perforation

Esophageal perforation

Gastric perforation

Bowel perforation

Bleeding - in rare cases, significant bleeding that may
result in surgery and/or transfusion

Aspiration

Adynamic ileus

Infection with and without fever

Hepatic abscess

Pancreatitis (with or without bile duct blockage)

Biliary disease/cholelithiasis

Inability to remove GI liner endoscopically, resulting
in surgical removal

Prolonged procedure time

Complications associated with an endoscopic
procedure (i.e., sore throat or deep vein thrombosis)

Headache

Alopecia

Abdominal pain

Pain– flank/back
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