On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
Ascending Aortic Prosthesis IFU 7
English
Do not attempt to rotate the valve if any significant resistance to rotation
is encountered and only use the valve rotator attached to the instrument
handle to rotate the valve. The torque required to rotate the valve in situ
should be about the same as that required when testing rotation before
implantation. If noticeably greater torque is required to rotate, stop
attempting rotation. If rotation is necessary and cannot be performed,
remove the prosthesis.
Use only On-X valve sizers when sizing the annulus. Sizers contain cylindri-
cal, conical, and aortic replica ends.
5. POTENTIAL ADVERSE EVENTS
Adverse events potentially associated with the use of aortic valved grafts
include, but are not limited to:
• angina
• cardiac arrhythmia
• endocarditis
• heart failure
• hemolysis
• hemolytic anemia
• hemorrhage
• myocardial infarction
• valve leaflet entrapment
(impingement)
• valve nonstructural dysfunction
• valve pannus overgrowth
• valve perivalvular leak
• valve regurgitation
• valve structural dysfunction
• valve thrombosis
• thromboembolism
• stroke
• graft infection
• false aneurysm, aneurysm
• secondary fistula formation
• graft occlusion or kinking
• excessive blood loss through
the graft
It is possible that these complications could lead to:
• reoperation
• explantation • permanent disability
• death
Mechanical prosthetic heart valves produce audible sounds as a normal
function of their operation. In some patients, these sounds may be objec-
tionable.
Risk of Re-use:
In accordance with the EU Medical Device Directive, 93/42/EEC, Annex I,
Section 13.6h, the device manufacturer must provide information on risks
associated with re-use of a single use device. Therefore, the following state-
ment is provided:
Risks of re-using the AAP device:
The implanted graft is customized to the patient. In addition to the risks
listed in this section, re-use in another patient, would risk exsanguination.
Additional risks are bloodborne pathogens, and bacterial infection.
6. INDIVIDUALIZATION OF TREATMENT
Adequate anticoagulant or anticoagulant/antiplatelet therapy should be
administered postoperatively. Selection of an anticoagulant or anticoagu-
lant/antiplatelet regimen is based on the particular needs of the patient, the
clinical situation and established professional guidelines.