Required Materials/Equipment; Packaging And Storage; Valve; Delivery System/Loading System - St.Jude Medical PRT-23 Mode D'emploi

• acute myocardial infarction,
• allergic reaction to antiplatelet agents, contrast medium, or valve components,
• aortic rupture,
• ascending aorta trauma,
• atrio-ventricular node block,
• cardiac arrhythmias,
• embolism,
• heart failure,
• hemodynamic compromise,
• hemolysis,
• hemolytic anemia,
• hemorrhage,
• hypotension or hypertension,
• infection,
• myocardial ischemia,
• mitral valve insufficiency,
• multi-organ failure,
• non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning),
• pericardial effusion,
• perforation of the myocardium or a blood vessel,
• pannus,
• sepsis,
• stroke,
• structural deterioration (i.e., calcification, leaflet tear),
• thrombosis,
• tamponade,
• valve migration, and
• vessel dissection or spasm.
It is possible these complications could lead to:
• transfusion,
• conversion to open surgical procedure,
• reoperation,
• emergent balloon valvuloplasty,
• emergent percutaneous coronary intervention (PCI),
• emergent surgery (i.e., coronary artery bypass, heart valve replacement),
• explantation,
• permanent disability,
• death, and
• permanent pacemaker.

REqUIRED MaTERIaLS/EqUIPMENT

The following materials and equipment are required for implantation of the Portico™ transcatheter heart valve:
• standard cardiac catheterization lab equipment
• fluoroscopy equipment appropriate for use in percutaneous coronary interventions
• transesophageal or transthoracic echocardiographic equipment
• sterile isotonic saline
• 20 cc luer-lock syringe
• high-pressure stopcock
• balloon catheter
• exchange length 0.035" (0.89 mm) super stiff guidewire
• 18 Fr or 19 Fr introducer
• three sterile 500 mL basins
• sterile 4" x 4" (10 cm x 10 cm) gauze

PaCKaGING aND STORaGE

Valve

The valve is supplied in a jar containing formaldehyde storage solution. The jar has a screw cap closure and tamper-evident seal. The valve is
supplied on a disposable holder. The contents of the jar are sterile and must be handled aseptically to prevent contamination. Store the valve in the
upright position.
CaUTION: Do not use the valve without thoroughly rinsing as directed.
CaUTION: Do not use the valve if the shipping temperature indicator on the product package has turned red, or if the valve has been
improperly stored in temperature conditions outside of the 5°C – 25°C (41°F – 77°F) range.

Delivery System/Loading System

The delivery system and loading system are sterilized with ethylene oxide gas. The delivery system is supplied in a tray within an outer pouch.
The loading system is supplied in a double-barrier tray. The inner delivery system/loading system trays are supplied sterile provided the outer
pouch/tray packaging is not opened or damaged.
5