Precautions; Magnetic Resonance (Mr) Safety; Potential Adverse Events - Biostable HAART 300 Instrucciones De Uso

• 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 300 Aortic Annuloplasty Device is selected using Sizers
consistent with the design intent of the Device. Use only the HAART
Sizers included in the HAART 301 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 calcification, fenestrations,
perforations, 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 300 Aortic Annuloplasty Device if the tamper-
evident seal is damaged, broken or missing.
• Dispose of used Devices as biohazardous waste.
• 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
Device at least 2mm 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
Directions for Use. A sufficient number of broad horizontal mattress
sutures should be used to elliminate gaps between the Device and the
adjacent annular tissues and to support the tension associated with
annular 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 tails 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 300 Aortic Annuloplasty Device should be current on
anticoagulation regimens.

8. Magnetic Resonance (MR) Safety

MR Conditional
Non-clinical testing has demonstrated that the HAART 300 Aortic Annu-
loplasty 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 1.5T and 3T
• Maximum spatial field gradient of 4,000-G/cm (40 T/m)
• Maximum MR system reported, whole body average specific
absorption rate (SAR) of 4.0-W/Kg (First RF Heating Level Controlled
Operating Mode) at 3T
DWG-01-009 Rev. N - ©2021
Under the scan conditions defined above, the HAART 300 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.
In non-clinical testing, the image artifact caused by the Device extends
approximately 10 mm from the HAART 300 Aortic Annuloplasty Device
when imaged with a gradient echo pulse sequence and a 3T MRI sys-
tem.

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 300
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 300
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
Allergic reaction
Angina
Aortic insufficiency
Arrhythmia
Atrioventricular block
Death
Device explant
Device fracture
Device migration or malposition
requiring intervention
Endocarditis
Extended surgery time or aborted
procedure
Fever
Gastrointestinal disorders
Heart Failure
Hematoma
Hemolysis or hemolytic anemia
Hemorrhage
Hypertension
Infection – local, bacteremia,
sepsis
Leaflet damage
Left Ventricular Outflow Tract
Obstruction
Myocardial infarction
Neurological events
(including TIA, stroke, and
psychomotor deficit)
Pain (patient discomfort)
Pericardial effusion
Permanent pacemaker
Pleural effusion
Psychological problems
Renal insufficiency / failure
Reoperation
Respiratory system disorders
Ring dehiscence
Stenosis
Suture injury to coronary arteries
Syncope
Thrombosis or thromboembolism
Toxic reaction
Wound healing problems
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