Directions For Use; Pre-Implant Handling; Removing The Valve From The Outer Packaging; Removing The Valve From The Storage Container - St.Jude Medical PRT-23 Mode D'emploi

DIRECTIONS FOR USE

Use standard imaging techniques (including computed tomography [CT] and/or echocardiography) to determine aortic annulus diameter.

Pre-Implant handling

The valve package should not be opened until implantation and sizing are certain.
Warnings:
• Do not use the valve, delivery system, or loading system if the "USE BY" date has elapsed or if the integrity of the sterile packaging has been
compromised.
• Do not use the valve if fluid is leaking from the packaging.
• Do not resterilize the valve, delivery system, or loading system by any method.
• Do not use the valve, the delivery system, or the loading system if it has been dropped, damaged or mishandled in any way.

Removing the Valve from the Outer Packaging

Precautions
• Do not place the non-sterile exterior of the valve container in the sterile field.
• Do not expose the valve to solutions other than the formaldehyde storage solution in which it was shipped, the sterile isotonic saline solution
used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
• Do not add antibiotics to either the formaldehyde storage solution or the sterile isotonic saline rinse solution.
• Do not apply antibiotics to the valve.
1. Once the valve container has been removed from the outer packaging, examine the container for evidence of damage.
CaUTION: Do not use the valve if the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the
packaging.
waRNING: Do not use the valve if it is not completely covered by formaldehyde storage solution.
2. Prior to use, verify the valve size and "USE BY" date on the packaging label and the container label.
3. To remove the valve from the container, break the seal and remove the screw-top closure.
CaUTION: avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin
exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

Removing the Valve from the Storage Container

1. Using sterile forceps or gloved hands, carefully grasp the valve holder and remove the valve from the jar. Drain the valve completely.
CaUTION: Do not handle the valve or leaflet tissue with unprotected forceps or sharp instruments.
2. Remove the valve from the valve holder by carefully compressing the aortic end of the valve stent circumferentially. Take care not to touch the
valve tissue.
3. Inspect the valve for damage. Do not use the valve if there is any sign of damage or deterioration.

Rinsing the Valve

CaUTION: Do not use the valve without thoroughly rinsing as directed.
CaUTION: Do not allow the tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the
formaldehyde storage solution.
1. Within the sterile field, prepare three sterile basins with a minimum of 500 mL of sterile isotonic saline in each basin. Saline in the first two
basins will be used for valve rinsing. Saline in the third basin will be used for delivery system preparation.
CaUTION: Do not use saline from the first or second basins for delivery system preparation.
NOTE: Chilled saline is not required.
2. Fully immerse the valve in the sterile isotonic saline solution in the first basin.
3. Continually rinse the valve for 10 seconds, using a gentle back-and-forth motion.
4. Repeat steps 2 and 3 in the second basin.
5. After rinsing, leave the valve fully immersed in the second basin until it is ready to be loaded.

Compressing the Valve in the Loading System

Perform steps 1-6 below in the sterile field, at room temperature.
CaUTION: Do not place the non-sterile packaging of the loading system in the sterile field.
1. Confirm the Portico™ valve size to be implanted. If implanting a 23 mm or 27 mm valve, press the base insert into the loading base. If
implanting a 25 mm valve, use the loading base without the base insert. To remove the base insert from the loading base, compress the two
tabs on the underside of the loading base.
2. Place the annulus end of the valve onto the loading base.
3. Wet the loading funnel in sterile isotonic saline.
4. Place the wide end of the loading funnel directly over the aortic end of the valve.
5. Gently push down on the loading funnel to compress the valve. Align the loading funnel slots with the tabs on the loading base. Rotate the
loading funnel slightly clockwise until it locks into the loading base. The aortic end of the valve will protrude out of the loading system assembly.
6. Look through the underside of the loading base to see if there is an opening through the leaflets for the radiopaque tip of the delivery system.
If necessary, use the leaflet tester to gently push the leaflets toward the stent frame to create an opening for the tip of the delivery system.

Loading the Valve on the Delivery System

Load the valve on the delivery system in the sterile field, at room temperature, under direct visualization.
CaUTION: Do not use the delivery system if it is kinked or damaged.
CaUTION: Do not place the non-sterile packaging of the delivery system in the sterile field.
NOTE: The valve must be loaded onto the delivery system by trained personnel.
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