Clinical Studies - GORE CARDIOFORM Instructions For Use Manual

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
Subjects With One or More Non-Serious Adverse Events
Anesthesia or Procedural
Incision site complication
Anesthesia complication
Procedural pain
Nervous System
Burning sensation
Migraine
Other
Respiratory, thoracic and mediastinal
Gastrointestinal
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.
3
50
12 (24.0%)
8 (16.0%)
4 (8.0%)
3 (6.0%)
2 (4.0%)
2 (4.0%)
1 (2.0%)
1 (2.0%)
3 (6.0%)
2 (4.0%)
1 (2.0%)