GORE CARDIOFORM Instructions For Use Manual

INSTRUCTIONS FOR USE FOR:

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1

INSTRUCTIONS FOR USE FOR:

GORE® CARDIOFORM Septal Occluder

Carefully read all instructions prior to use. Observe all warnings and
precautions noted throughout these instructions.
Failure to do so may result in complications.

DESCRIPTION

The GORE® CARDIOFORM Septal Occluder consists of an implantable Occluder
and a Delivery System. The Occluder is comprised of a platinum-filled nickel­titanium (Nitinol) wire frame covered with expanded polytetrafluoroethylene
(ePTFE). The ePTFE includes a hydrophilic surface treatment to facilitate
echocardiographic imaging of the Occluder and surrounding tissue during
implantation. When fully deployed, the Occluder assumes a double-disc
configuration to prevent shunting of blood between the right and left atria. The
Delivery System consists of a 75 cm working length 10 Fr outer diameter Delivery
Catheter that is coupled to a Handle. The Handle facilitates loading, deployment,
and locking of the Occluder. The Handle also allows repositioning and retrieval of
the Occluder via the Retrieval Cord, if necessary.
The Occluder is available in diameters of 15, 20, 25, and 30 mm. The Occluder is
delivered using conventional catheter delivery techniques and may be delivered
with the aid of a 0.035" guidewire (or smaller), if desired.

FIGURE 1: GORE® CARDIOFORM Septal Occluder

FIGURE 1a: Left Atrial View

Left Atrial Eyelet

Control Catheter (Gray)

Delivery Catheter (Blue)

FIGURE 1b: Right Atrial View

Occluder Leaflet

Platinum-Filled
Nitinol Wire Frame

Lock Loop

Right Atrial Eyelet

FIGURE 2: GORE® CARDIOFORM Septal Occluder Delivery System

Left Atrial Eyelet

Flush Port

Packaging
Insert (clear)

Occluder Lock
(red)

Delivery Catheter (Blue)

Retrieval Cord

Slider (gray)

Retrieval Cord Lock (red)

Handle

Retrieval Luer

Delivery Catheter (blue)

- 75 cm Working Length -

INDICATIONS / INTENDED USE

The GORE® CARDIOFORM Septal Occluder is a permanently implanted device
indicated for the percutaneous, transcatheter closure of ostium secundum atrial
septal defects (ASDs).

CONTRAINDICATIONS

The GORE® CARDIOFORM Septal Occluder is contraindicated for use in patients:

• Unable to take anti-platelet or anticoagulant medications such as aspirin,
heparin, or warfarin.

• With anatomy where the GORE® CARDIOFORM Septal Occluder size or
position would interfere with other intracardiac or intravascular structures,
such as cardiac valves or pulmonary veins.

• With active endocarditis, or other infections producing bacteremia, or
patients with known sepsis within one month of planned implantation,
or any other infection that cannot be treated successfully prior to device
placement.

• With known intracardiac thrombi.

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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 post­implant. 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.

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Adverse Events

Clinical Summary

The GORE® CARDIOFORM Septal Occluder was evaluated in a multi-center,
non-randomized, Pivotal Study that included 50 subjects. An Independent
Data Reviewer provided external oversight and review of subject safety data,
including evaluation of all reported adverse events for accuracy of event coding,
seriousness, and relationship to the device. An event was considered a Serious
Adverse Event if it led to death or serious deterioration in health that resulted in
a life threatening illness or injury or in permanent impairment. Device Events, a
type of Serious Adverse Event, were defined as any post-procedure embolization,
post-procedural device removal, or any other reintervention to the septal defect.

Deaths

No deaths have been reported in study subjects.

Serious Adverse Events

No Serious Adverse Events, including Device Events, were observed in any study
subjects through the 6-month follow-up.

Non-Serious Adverse Events

Non-Serious Adverse Events reported through the 6-month follow-up for Pivotal
Study subjects and determined to be potentially or definitely related to the
implant procedure or the device are presented in Table 1.

Table 1. Subjects with Non-Serious Adverse Events Through 6 Months
– Pivotal Study

Subjects Evaluable for Safety 50

Subjects With One or More Non-Serious Adverse Events 12 (24.0%)

Anesthesia or Procedural 8 (16.0%)

Incision site complication 4 (8.0%)

Anesthesia complication 3 (6.0%)

Procedural pain 2 (4.0%)

Nervous System 2 (4.0%)

Burning sensation 1 (2.0%)

Migraine 1 (2.0%)

Other 3 (6.0%)

Respiratory, thoracic and mediastinal 2 (4.0%)

Gastrointestinal 1 (2.0%)

POTENTIAL DEVICE OR PROCEDURERELATED ADVERSE EVENTS

Adverse Events associated with the use of the Occluder may include, but are not
limited to:

• Repeat procedure to the septal defect

• Device embolization

• New arrhythmia requiring treatment

• Intervention for device failure or ineffectiveness

• Access site complications requiring surgery, interventional procedure,
transfusion, or prescription medication

• Thrombosis or thromboembolic event resulting in clinical sequelae

• Perforation of a cardiovascular structure by the device

• Device fracture resulting in clinical sequelae or surgical intervention

• Occluder disc expansion resulting in clinical sequelae or intervention

• Air embolism

• Myocardial infarction

• Pericardial tamponade

• Cardiac arrest

• Renal failure

• Sepsis

• Significant pleural or pericardial effusion requiring drainage

• Significant bleeding

• Endocarditis

• Headache or migraine

• TIA or stroke

• Death

CLINICAL STUDIES

The GORE® CARDIOFORM Septal Occluder was evaluated for safety and
effectiveness in a multicenter, non-randomized Pivotal Study with 50 subjects
enrolled for closure of ostium secundum atrial septal defects.

Design

Patient Selection
Subjects enrolled in the Pivotal Study were required to have an ostium secundum
atrial septal defect with evidence of right heart volume overload. Subjects
were eligible for enrollment if their defect measured ≤ 17 mm in diameter by
stop-flow balloon sizing and had adequate septal rims to successfully retain the
occluder. Exclusion criteria included:

• Significant known pre-existing electrophysiologic, structural cardiovascular
defect, or other comorbidities that could elevate morbidity / mortality
beyond what is common for ASD or would be expected to require surgical
treatment within three years of device placement.

• Systemic or inherited conditions that would significantly increase subject
risk of major morbidity and mortality during the term of the study.

• Anatomy where the size or position of the occluder would interfere with
other intracardiac or intravascular structures, such as cardiac valves or
pulmonary veins.

• Active endocarditis, other infections producing bacteremia, or known
sepsis within one month of planned implantation, or any other infection
that could not be treated successfully prior to device placement.

• One or more known intracardiac thrombi.

• Uncontrolled arrhythmia.

• History of stroke resulting in a significant morbidity or disability.

• Pregnant or lactating at time of enrollment.

• Contraindication to antiplatelet therapy.