Potential Adverse Events; Direction For Use - sorin Perceval S Gebrauchsanweisung

12.Subjects with anatomical characteristics outside the specification given in
Table 1.

10. POTENTIAL ADVERSE EVENTS

The risks or potential adverse events (in alphabetical order) associated with car-
diac valve replacement with a bioprosthesis include, but may not be limited to:
arrhythmias, cardiac tamponade, death, endocarditis, heart failure (acute cardiac
failure), hemolysis, hemolytic anemia, clinically significant hemorrhage (bleeding),
infection other than endocarditis, myocardial infarction, nonstructural valve dys-
function (e.g. pannus), pericardial effusion, intravalvular and paravalvular leak,
prosthesis thrombosis, stroke or any related neurologic disorders, structural valve
deterioration, thromboembolism, tissue dehiscence, stenosis.
Adverse events may arise due to the individual patient reactions to the implanted
prosthesis.
Beyond the previously mentioned adverse events, specific events related to the
implant of the Perceval S prosthesis may include, but not be limited to dislodg-
ment and/or migration of the prosthesis.

11. DIRECTION FOR USE

Personnel training
Perceval S implantation shall be performed only by physician and associated staff
trained on Perceval S preparation and implantation technique.
Implant site preparation
The device implant is performed under surgery using an access allowing expo-
sure of the aortic valve. The surgical approaches are well-known and consoli-
dated state-of-the-art practice.
1. Expose the aortic valve via transverse aortotomy.
WARNING: Oblique aortotomy is not recommended since release of the
device at the implant might result in aortotomy suture difficulties.
2. Perform the aortic incision distal to the sinotubular junction, to preserve a seg-
ment of ascending aorta above the upper limit of the prosthetic valve. A tran-
sverse aortotomy located at least 3.5 cm above the aortic annulus or at least
0.5 cm above the sinotubular junction is considered optimal. In any case, make
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