DWG-01-023 Rev. C - ©2021
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4.3. Accessories
The HAART 201 Instrument Set (Figure 3) is comprised of two (2) Han-
dles, four (4) Sizers and a Gage Sphere. Handles are made from ASTM
A276 stainless steel and the Sizers and Gage Sphere are fabricated
from polyphenylsulfone.
The Handle may be threaded into the Sizers and Gage Sphere. The
Handle may also be threaded into the face of the Holder to facilitate
removal of the Device from the packaging and positioning the Device
during the procedure (Figure 2). The Handle may be bent in the nar-
rowed section to present the Sizers, Gage Sphere, and Device to the
surgical site in the desired manner.
Warning: The Sizers, Gage Sphere, and Handle are intended for multi-
ple uses provided they are inspected before each use for signs of dam-
age. A cleaning and steam sterilization process has been validated for
these reusable instruments for use by the hospital. Before each use,
the Sizers and Gage Sphere should be visually inspected for crazing of
polymer materials, cracks, signs of structural weakness, or unreadable
Figure 1. HAART 200 Aortic Annuloplasty Device on holder
Figure 2. HAART 200 Aortic Annuloplasty
Device and holder affixed to handle
Figure 3. HAART 201 Instrument Set
markings. The Handle should be inspected for visible cracks or signs of
structural weakness before each use and after bending. Replace any
instrument that exhibits these faults as they may not function properly
and could cause patient injury. For more information on instruments, see
the HAART 201 Instrument Set IFU.
5. Contraindications
•
The Device is contraindicated in patients with a porcelain aorta.
•
The Device is contraindicated in patients with evolving bacterial
endocarditis.
•
The Device is contraindicated in patients with heavily calcified valves.
6. Warnings
•
The HAART 200 Aortic Annuloplasty Device is for Single Use
Only. Do not re-use the Device. In addition to the risks listed under
Complications, re-use may cause procedural complications including
Device damage, compromised Device biocompatibility, and Device
contamination. Re-use may result in infection, serious injury, or
patient death.
•
The decision to use an annuloplasty device must be made by the
responsible physician on an individual basis after evaluation of the
risks and benefits accrued to the patient in comparison to alternate
treatment.
•
Do not attempt to deform or reshape the annuloplasty Device.
•
The HAART 200 Aortic Annuloplasty Device has been sterilized
by gamma irradiation methods and is provided sterile in a double
packaged container. No steam sterilization cycle has been validated
for the sterilization of the Device.
•
Valve repair patients subjected to subsequent dental procedures or
other surgical procedures should receive prophylactic antibiotic drug
therapy to minimize the risk of systemic bacteremia and prosthetic
endocarditis.
•
Correct annuloplasty device sizing is an important element of successful
valve repair. Significant undersizing can result in valve stenosis or ring
dehiscence. Oversizing can result in valve regurgitation. The size of
the HAART 200 Aortic Annuloplasty Device is selected using Sizers
consistent with the design intent of the Device. Use only the HAART
Sizers included in the HAART 201 Instrument Set to select the proper
Device size. Do not use the Holder as a sizing tool.
7. Precautions
•
Only surgeons having received training in HAART Device implantation
and sizing techniques should use this Device.
•
Aortic valve leaflet reconstruction is routinely required to create
valve competence during aortic valve repair. Annuloplasty using the
HAART Device should be combined with leaflet reconstruction when
indicated.
•
Complex leaflet lesions including calcifications, fenestrations, per-
forations, nodular scarring and retraction, and tissue insufficiency
requiring patch materials may be a risk factor for repair failure.
•
Do not use the Device after the expiration date printed on the label.
•
To ensure the sterility and integrity of the Device, it should be stored
in the outer cardboard box until needed for introduction into the sterile
field. Do not use a Device that has been removed from the double
packaging and dropped, soiled, or otherwise damaged.
•
Do not use the HAART 200 Aortic Annuloplasty Device if the tamper-
evident seal is damaged, broken or missing.
•
Dispose of used Devices as biohazardous waste.
