DWG-01-023 Rev. C - ©2021
4
•
To avoid damage to the fabric covering the Device, do not use suture
needles with cutting edges during implantation.
•
Implantation sutures should be placed deeply to position the HAART
devices at least 2 mm below the leaflet aortic junction and the tops of
the subcommissural triangles in order to prevent contact between the
leaflets and the Device.
•
To prevent sutures from pulling through the native annular tissue,
Pledgets should be used with the sutures as described in the Direc-
tions for Use. A sufficient number of broad horizontal mattress sutures
should be used to eliminate gaps between the Device and the adja-
cent annular tissues and to support the tension associated with annu-
lar reduction.
•
Sutures should be pulled tight and tied tightly so that the Device is in
firm contact with the adjacent annular tissues. Suture tails should be
tied down to the lateral aspect of the annular Pledgets, as described
in the Directions for Use, to prevent leaflet damage from long suture
tails. The sutures should also be cut very short.
•
Provide careful monitoring of the patient’s anticoagulation status
when postoperative anticoagulation therapy is used. Surgeons who
use the HAART 200 Aortic Annuloplasty Device should be current on
anticoagulation regimens.
8. Magnetic Resonance (MR) Safety
MR Conditional
Non-clinical testing has demonstrated that the HAART 200 Aortic
Annuloplasty Device is MR Conditional. A patient with this device can
be safely scanned in an MR system meeting the following conditions:
•
Static magnetic field of 1.5 T and 3 T
•
Maximum spatial field gradient of 4,000 G/cm (40 T/m)
•
Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 4.0 W/kg (First Level Controlled Operating
Mode) at 3 T
RF Heating
Under the scan conditions defined above, the HAART 200 Aortic Annu-
loplasty Device is expected to produce a maximum temperature rise of
less than 3.0°C after 15 minutes of continuous scanning.
Caution: The RF heating behavior does not scale with static field
strength. Devices that do not exhibit detectable heating at one field
strength may exhibit high values of localized heating at another field
strength.
MR Artifact
In non-clinical testing, the image artifact caused by the device extends
approximately 10 mm from the HAART 200 Aortic Annuloplasty Device
when imaged with a gradient echo pulse sequence and a 3 T MRI system.
9. Potential Adverse Events
Each prospective patient should be informed about the benefits and
risks of valve repair and annuloplasty surgery before the procedure.
Serious complications, including death, are possible with any open
heart surgery procedure including the implantation of the HAART 200
Aortic Annuloplasty Device. These potential complications include those
associated with open heart surgery in general and the use of general
anesthesia. The potential complications associated with the HAART 200
Aortic Annuloplasty Device and its implantation procedure are listed in
Table 1.
Table 1. Possible Complications Associated with the Device/Procedure
Abrasion of the natural valve
Leaflet damage
Allergic reaction
Left Ventricular Outflow Tract
Obstruction
Angina
Myocardial infarction
Aortic insufficiency
Neurological events
(including TIA, stroke, and
psychomotor deficit)
Arrhythmia
Pain (patient discomfort)
Atrioventricular block
Pericardial effusion
Death
Permanent pacemaker
Device explant
Pleural effusion
Device fracture
Psychological problems
Device migration or malposition
requiring intervention
Renal insufficiency / failure
Endocarditis
Reoperation
Extended surgery time or aborted
procedure
Respiratory system disorders
Fever
Ring dehiscence
Gastrointestinal disorders
Stenosis
Heart Failure
Suture injury to coronary arteries
Hematoma
Syncope
Hemolysis or hemolytic anemia
Thrombosis or thromboembolism
Hemorrhage
Toxic reaction
Hypertension
Wound healing problems
Infection – local, bacteremia,
sepsis
10. How Supplied
10.1. Packaging
The HAART 200 Aortic Annuloplasty Device is available in 19, 21, 23
and 25 mm sizes. Each HAART 200 Aortic Annuloplasty Device shelf
box contains Pledgets and a single annuloplasty Device assembly
consisting of the Device sutured onto its corresponding Holder. The
assembled Device and Holder are packaged within nested, sealed
trays. Pledgets are packaged separately within nested pouches. The
packaging system is designed to ease placement of the Device into
the sterile field. The components within the packaging are sterile if the
pouches, trays, and lids are undamaged and unopened. The surfaces
of the outer packaging are NONSTERILE and must not be placed in
the sterile field.
10.2. Storage
Store the product in its original packaging, including the outer shelf
box, in a clean and dry area to protect the product and minimize the
potential for contamination. Stock rotation is recommended at regular
intervals to ensure usage before the expiration date printed on the box
label. Do not use the Device after the expiration date printed on the
label.
