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WARNINGS
• The GORE® CARDIOFORM Septal Occluder is not recommended for, and has
not been studied in, patients with other anatomical types of ASDs that are
eccentrically located on the septum (e.g. sinus venosus ASD and ostium
primum ASD), or fenestrated Fontan.
• The GORE® CARDIOFORM Septal Occluder has not been studied in patients
with multiple defects requiring placement of more than one device.
• The GORE® CARDIOFORM Septal Occluder is not recommended for defects
larger than 17 mm.
• Regarding device sizing:
- The defect and atrial chamber size should be evaluated by
Transesophageal (TEE) or Intracardiac Echo (ICE) with color flow
Doppler measurement to confirm that there is adequate space to
accommodate the selected occluder size without impinging on
adjacent cardiac structures (e.g., A-V valves, ostia of the pulmonary
veins, coronary sinus, or other critical features).
- There must be adequate room in the atrial chambers to allow the
right and left atrial discs to lie flat against the septum with disc
spacing equal to the septal thickness, and without interference with
critical cardiac structures or the free wall of the atria.
- An occluder that pulls through the defect after disc conformation
may be too small and should be removed and replaced with a
larger size.
• Embolized devices must be removed. An embolized device should not be
withdrawn through intracardiac structures unless the occluder has been
adequately collapsed within a sheath.
• The GORE® CARDIOFORM Septal Occluder should be used only by
physicians trained in its use, and in transcatheter defect closure techniques.
• Patients allergic to nickel may suffer an allergic reaction to this device.
Certain allergic reactions can be serious; patients should be instructed to
notify their physicians immediately if they suspect they are experiencing an
allergic reaction such as difficulty breathing or inflammation of the face or
throat. Some patients may also develop an allergy to nickel if this device is
implanted.
PRECAUTIONS
Handling
• The GORE® CARDIOFORM Septal Occluder is intended for single use only.
An unlocked and removed occluder cannot be reused. Gore does not have
data regarding reuse of this device. Reuse may cause device failure or
procedural complications including device damage, compromised device
biocompatibility, and device contamination. Reuse may result in infection,
serious injury, or patient death.
• Inspect the package before opening. If seal is broken, contents may not be
sterile.
• Inspect the product prior to use in the patient. Do not use if the product
has been damaged.
• Do not use after the labeled “use by” (expiration) date.
• Do not resterilize.
Procedure
• The GORE® CARDIOFORM Septal Occluder should only be used in patients
whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or
12 Fr delivery sheath when a guidewire is used).
• Retrieval equipment such as large diameter sheaths, loop snares, and
retrieval forceps should be available for emergency or elective removal of
the occluder.
• An Activated Clotting Time (ACT) greater than 200 seconds should be
maintained throughout the procedure.
• The GORE® CARDIOFORM Septal Occluder should be used only in
conjunction with appropriate imaging techniques to assess the septal
anatomy and to visualize the wire frame.
• If successful deployment cannot be achieved after three attempts,
an alternative device or treatment for ASD closure is recommended.
Consideration should be given to the patient’s total exposure to radiation
and anesthesia if prolonged or multiple attempts are required for the
placement of the GORE® CARDIOFORM Septal Occluder.
• Expansion of an occluder disc may occur in the periprocedural time period.
If there is uncertainty that an expanded device remains locked, fluoroscopic
examination is recommended in order to identify if the Lock Loop captures
all three eyelets.
• Removal of the Occluder should be considered if:
- The Lock Loop does not capture all three eyelets
- The Occluder will not come to rest in a planar position apposing the
septal tissue
- The selected Occluder allows excessive shunting
- There is impingement on adjacent cardiac structures
Post Procedure
• Patients should take appropriate prophylactic antibiotic therapy consistent
with the physician’s routine procedures following device implantation.
• Patients should be treated with antiplatelet therapy for six months post-
implant. The decision to continue antiplatelet therapy beyond six months is
at the discretion of the physician.
• In patients sensitive to antiplatelet therapy, alternative therapies, such as
anticoagulants, should be considered.
• Patients should be advised to avoid strenuous physical activity for a period
of at least two weeks after occluder placement.
• Patients should have Transthoracic Echocardiographic (TTE) exams prior to
discharge, and at 1, 6, and 12 months after occluder placement to assess
defect closure. Attention should be given to the stability of the device on
the atrial septum during these assessments, as a lack of device stability may
be indicative of wire frame fractures. In instances where device stability is
questionable, fluoroscopic examination without contrast is recommended
in order to identify and assess wire frame fractures.
