Idiomas disponibles
Idiomas disponibles
6.0 Precautions
• Long-term durability has not been established for the THV. Regular
medical follow-up is advised to evaluate valve performance.
• Glutaraldehyde may cause irritation of the skin, eyes, nose and throat.
Avoid prolonged or repeated exposure to, or breathing of, the solution.
Use only with adequate ventilation. If skin contact occurs, immediately
flush the affected area with water; in the event of contact with eyes,
seek immediate medical attention. For more information about
glutaraldehyde exposure, refer to the Material Safety Data Sheet
available from Edwards Lifesciences.
• The safety and effectiveness of the THV implantation has not been
established for patients who have:
• Blood dyscrasias defined as: leukopenia, acute anemia,
thrombocytopenia, or history of bleeding diathesis or coagulopathy
• A known hypersensitivity or contraindication to aspirin, heparin,
™
ticlopidine (Ticlid
), or clopidogrel (Plavix
contrast media, which cannot be adequately premedicated
• Positive urine or serum pregnancy test in female subjects of child-
bearing potential
• A concomitant paravalvular leak where the failing bioprosthesis is
not securely fixed in the native annulus or is not structurally intact
(e.g., wireform frame fracture)
• If a significant increase in resistance occurs when advancing the
catheter through the vasculature, stop advancement and investigate
the cause of resistance before proceeding. Do not force passage, as this
could increase the risk of vascular complications.
• Caution should be used in vessels that have diameters less than
5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F
Edwards eSheath introducer set respectively.
• Use caution in tortuous or calcified vessels that would prevent safe
entry of the introducer set.
• Appropriate antibiotic prophylaxis is recommended post-procedure in
patients at risk for prosthetic valve infection and endocarditis.
• Do not overinflate the deployment balloon, as this may prevent proper
valve leaflet coaptation and thus impact valve functionality.
• Patient venous anatomy should be evaluated to prevent the risk of
access that would preclude the delivery and deployment of the device.
• Patient should be heparinized to maintain the ACT at ≥ 250 sec prior to
introduction of the delivery system in order to prevent thrombosis.
• Residual mean gradient may be higher in a "THV-in-failing
bioprosthesis" configuration than that observed following
implantation of the valve inside a native annulus using the same size
device. Patients with elevated mean gradient post procedure should
be carefully followed. It is important that the manufacturer, model and
size of the preexisting bioprosthetic valve be determined, so that the
appropriate valve can be implanted and a prosthesis-patient mismatch
be avoided. Additionally, pre-procedure imaging modalities must be
employed to make as accurate a determination of the inner diameter
as possible.
7.0 Potential Adverse Events
Potential risks associated with the anesthesia, interventional procedure
and imaging include but are not limited to:
• Death
• Stroke/transient ischemic attack
• Respiratory insufficiency or respiratory failure
• Cardiovascular or vascular injury, such as perforation or damage
(dissection) of vessels, myocardium or valvular structures including
rupture of the pulmonary RVOT that may require intervention
• Pericardial effusion/cardiac tamponade
• Embolic event: air, calcific material, thrombus, device fragments
• Infection including incisional site infection, septicemia and
endocarditis
• Myocardial infarction
• Renal insufficiency or renal failure
• Conduction system injury
• Arrhythmia
• Arteriovenous (AV) fistula
• Systemic or peripheral nerve injury
• Systemic or peripheral ischemia
• Pulmonary edema
• Pneumothorax
™
), or sensitivity to
3
• Pleural effusion
• Atelectasis
• Blood loss requiring transfusion or intervention
• Anemia
• Radiation injury
• Electrolyte imbalance
• Hypertension or hypotension
• Allergic reaction to anesthesia, contrast media, antithrombotic therapy,
device materials or bovine pericardial tissue
• Hematoma or ecchymosis
• Syncope
• Pain
• Exercise intolerance or weakness
• Inflammation
• Angina
• Fever
• Cardiac failure
Potential risks associated with the valve, delivery system and/or
accessories include, but may not be limited to, the following:
• Cardiac arrest
• Cardiogenic shock
• Coronary flow obstruction/transvalvular flow disturbance
• Device thrombosis requiring intervention
• Injury to tricuspid valve
• Device embolization requiring intervention
• Device acute migration or malposition requiring intervention
• Endocarditis
• Hemolysis / hemolytic anemia
• Structural valve deterioration (wear, fracture, calcification, leaflet tear/
tearing from the stent posts, leaflet retraction, suture line disruption of
components of the prosthetic valve, thickening, stenosis)
• THV dysfunction resulting in pulmonary valve symptoms
• Paravalvular or transvalvular leak
• Mechanical failure of delivery system, and/or accessories
• Emergent and non-emergent re-intervention
• Dyspnea
For a patient/user/third party in the European Economic area; if, during
the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and your national
competent authority, which can be found at https://ec.europa.eu/
growth/sectors/medical-devices/contacts_en.
8.0 Directions for Use
8.1 System Compatibility
20 mm
System
Product Name
Edwards SAPIEN 3
9600TFX
Transcatheter
(20 mm)
Heart Valve
Edwards
COMMANDER
9610TF20
Delivery System
Edwards eSheath
Introducer Set
Inflation Device
Edwards Crimper
Qualcrimp crimping accessory, Crimp Stopper and Loader provided by
Edwards Lifesciences
Additional Equipment:
• Other compatible sheath:
• Valve size: 20, 23, 26 mm, GORE DrySeal Flex Introducer Sheath (24F,
65 cm)
• Valve size: 29 mm, GORE DrySeal Flex Introducer Sheath (26F, 65 cm)
Table 5
23 mm
26 mm
29 mm
System
System
System
Model
9600TFX
9600TFX
9600TFX
(23 mm)
(26 mm)
(29 mm)
9610TF23
9610TF26
9610TF29
9610ES14
9610ES16
96402
96406
9600CR
