Warnings; Precautions; Pre-Implantation Precautions; Implantation Precautions - St.Jude Medical PRT-23 Mode D'emploi

• Any leaflet configuration other than tricuspid.
• Inability to tolerate antiplatelet/anticoagulant therapy.

waRNINGS

• Perform Portico™ valve implantation in a facility where emergency aortic valve surgery is available.
• Verify that the patient's cardiac anatomy is consistent with the specifications set forth in Table 2.
• For single use only. Do not reuse, reprocess, or resterilize the valve, delivery system, or the loading system. Reuse, reprocessing, and/or
resterilization creates a risk of contamination of the devices and/or device failure, which could cause patient injury, illness or death.
• Do not manipulate or handle the valve with sharp or pointed objects.
• Rinse the valve as directed before loading the valve onto the delivery system.
• Do not use the valve, the delivery system, or the loading system if the "USE BY" date has elapsed.
• Exercise care to prevent kinking of the delivery system when removing it from the packaging.

PRECaUTIONS

Pre-Implantation Precautions

• Balloon aortic valvuloplasty (BAV) of the native aortic valve is recommended prior to delivery system insertion.
• 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.
• Do not use the valve if the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
• Do not advance the delivery system without the guidewire extending from the tip.
• Do not use the valve without thoroughly rinsing as directed.
• Do not use the delivery system without thoroughly flushing as directed in the Directions for Use section.

Implantation Precautions

• Do not deploy the valve if excessive resistance to deployment is encountered. If the valve does not deploy easily, re-sheath the valve, remove it
from the patient, and use a different valve and delivery system.
• Follow the procedure in "Implanting the Valve" to reposition the valve or to remove the valve from the patient.
• Do not attempt to reposition the valve by advancing it distally unless the valve has been fully re-sheathed within the delivery system.
• Do not re-sheath the valve more than two times prior to final valve release. Additional re-sheath attempts may compromise product performance.

Post-Implantation Precautions

• Exercise care when removing the delivery system from the patient.
• Exercise care when crossing the valve with adjunctive devices.
• Once the valve is fully deployed, repositioning and retrieval of the valve is not possible. Attempted retrieval (e.g., use of a guidewire, snare,
or forceps) may cause aortic root, coronary artery, and/or myocardial damage.

MaGNETIC RESONaNCE (MR) SaFETy

Non-clinical testing has demonstrated that Portico™ transcatheter heart valves are MR Conditional. Patients can safely be scanned immediately
after implantation under the following conditions:
• Static magnetic field of 1.5 tesla (1.5T) or 3.0 tesla (3.0T).
• Maximum spatial gradient field less than or equal to 3,000 Gauss/cm (30T/m).
• Normal Operating Mode: Maximum whole-body averaged specific absorption rate of:
˚ 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T.
˚ 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T.

1.5T Radio Frequency (RF) heating

In non-clinical testing with body coil excitation, the valve produced a total temperature rise of approximately 3.9°C when exposed to a whole-
body averaged specific absorption rate (SAR) of 2.8 W/kg for 15 minutes of scanning in a 1.5 tesla MR system (Siemens MAGNETOM Espree
SYNGO MR B17 software, Erlangen, Germany).
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Scaling of the SAR and observed heating indicates that a SAR of 2.0 W/kg would be expected to yield a total localized temperature rise of less
than 3.0ºC in Normal Operating Mode. Subtracting control heating from the total temperature rise obtained as described yields an expected
differential temperature rise in Normal Operating Mode of less than approximately 2.0°C.

3.0T RF heating

In non-clinical testing with body coil excitation, the valve produced a total temperature rise of approximately 6.7ºC when exposed to a whole-body
averaged specific absorption rate (SAR) of 3.2 W/kg for 15 minutes of scanning in a 3.0 tesla MR system (Siemens MAGNETOM Trio
MR A35 4VA35A software, Erlangen, Germany).
Scaling of the SAR and observed heating indicates that SAR of 2.0 W/kg would be expected to yield a total localized temperature rise of less than
4.5ºC in Normal Operating Mode. Subtracting control heating from the total temperature rise obtained as described yields an expected differential
temperature rise in Normal Operating Mode of less than approximately 3.0°C.
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.

MR artifacts

MR image quality may be compromised if the area of interest is the same or relatively close to the position of the valve, and it may be necessary
to optimize the MR imaging parameters. The valve was evaluated under 1.5T and 3.0T test conditions, in accordance with ASTM F2119-07. The
lumen may be visualized, in particular at the wide end of the stent, depending upon the pulse sequence employed. The shape of the artifact
followed the approximate contour of the valve. Under 1.5T test conditions, the artifact extended radially up to 0.5 cm from the valve on spin echo
images and 0.4 cm on gradient echo images. Under 3.0T test conditions, the artifact extended radially up to 0.7 cm from the valve on spin and
gradient echo images.

POTENTIaL aDVERSE EVENTS

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to:
• access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.),
• acute coronary obstruction,
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