Patient Selection And Treatment; Individualization Of Treatment; Clinician Use Information; Inspection Prior To Use - Abbott XIENCE Sierra Manual

• Pneumonia
• Pyrexia
• Rash
• Renal failure
• Upper respiratory tract infection
• Urinary tract infection
• Venous thromboembolism
• Vomiting
• Wound healing complications (including wound infections and lymphocele)
8.0

PATIENT SELECTION AND TREATMENT

8.1

Individualization of Treatment

The risks and benefits described above should be considered for each patient before using
a device from the family of XIENCE EECSS. Patient selection factors to be assessed should
include judgment regarding risk of antiplatelet therapy. Special consideration should be given
to those patients with recently active gastritis or peptic ulcer disease.
Antiplatelet drugs should be used in combination with the XIENCE EECSS, per the guidelines
from the American College of Cardiology, American Heart Association, and Society for
Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) and ESC guidelines.
Physicians should use the information from the large body of clinical evidence for XIENCE
stents, coupled with the current literature on drug-eluting stents, current guidelines and the
specific needs of individual patients, to determine the specific antiplatelet / anticoagulation
regimen to be used for their patients in general practice.
Current guidelines for the DAPT discontinuation should be followed and are recommended.
The decision to interrupt or discontinue DAPT is the responsibility of the treating physician,
taking into consideration the individual patient's condition. In case an unanticipated
interruption or discontinuation of DAPT is required any time after one month following
XIENCE coronary stent implantation, two-year data from the XIENCE coronary clinical trials
show low stent thrombosis rates and no observed increased risk for stent thrombosis.
It is very important that the patient comply with the post-procedural antiplatelet
recommendations. Premature discontinuation of prescribed antiplatelet medication could
result in a higher risk of thrombosis, myocardial infarction, or death. Prior to percutaneous
coronary intervention (PCI), if a surgical or dental procedure is anticipated that requires
early discontinuation of antiplatelet therapy, the interventionalist and patient should carefully
consider whether a drug-eluting stent and its associated recommended antiplatelet therapy
is the appropriate PCI choice. Following PCI, should a surgical or dental procedure be
recommended, the risks and benefits of the procedure should be weighed against the
possible risk associated with premature discontinuation of antiplatelet therapy.
Patients who require premature discontinuation of antiplatelet therapy secondary to
significant active bleeding, should be monitored carefully for cardiac events and, once
stabilized, have their antiplatelet therapy restarted as soon as possible per the discretion of
their treating physicians.
9.0

CLINICIAN USE INFORMATION

9.1

Inspection Prior to Use

1. Carefully inspect the sterile package before opening and check for damage to
the sterile barrier. Do not use if the integrity of the sterile package has been
compromised.
2. Do not use after the "Use by" date.
3. Tear open the foil pouch and remove the inner pouch.
Note: The outside of the inner pouch is NOT sterile. Open the inner pouch and pass or
drop the product into the sterile field using an aseptic technique.
4. Prior to using the XIENCE Sierra EECSS, carefully remove the system from the
package and inspect for bends, kinks, and other damage. Verify that the stent does
not extend beyond the radiopaque balloon markers. Do not use if any defects are
noted. However, do not manipulate, touch, or handle the stent, which may cause
coating damage, contamination, or stent dislodgement from the delivery balloon.
Note: At any time during use of the XIENCE Sierra EECSS, if the stainless steel proximal
shaft has been bent or kinked, do not continue to use the catheter.
9.2

Materials Required

• Appropriate arterial sheath
• Appropriate guiding catheter(s)
• 2 – 3 syringes (10 – 20 cc)
• 1,000 u/500 cc heparinized normal saline (HepNS)
• Rotating hemostatic valve with appropriate minimum inner diameter (0.096 inch
[2.44 mm])
• 0.014 inch (0.36 mm) x 175 cm (minimum length) guide wire
• Guide wire introducer
• Contrast diluted 1:1 with heparinized normal saline
• Inflation device
• Appropriate sized pre-dilatation angioplasty balloon
• Appropriate sized post-dilatation noncompliant angioplasty balloon
• Three-way stopcock
• Torque device
• Appropriate anticoagulation and antiplatelet drugs
9.3

Preparation

9.3.1 Packaging Removal

Note: The foil pouch is not a sterile barrier. The inner header bag (pouch) within the foil
pouch is the sterile barrier. Only the contents of the inner pouch should be considered
sterile. The outside surface of the inner pouch is NOT sterile.
1. Carefully remove the delivery system from its protective tubing for preparation of the
delivery system. When using a rapid exchange (RX) system, do not bend or kink the
hypotube during removal.
2. Remove the product mandrel and protective stent sheath by grasping the catheter
just proximal to the stent (at the proximal balloon bond site), and with the other
hand, grasp the stent protector and gently remove distally. If unusual resistance is
felt during product mandrel and stent sheath removal, do not use this product and
replace with another. Follow product returns procedure for the unused device.

9.3.2 Guide Wire Lumen Flush

1. Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch.
Note: Avoid manipulation of the stent while flushing the guide wire lumen, as this may
disrupt the placement of the stent on the balloon.
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9.3.3 Delivery System Preparation

1. Prepare an inflation device / syringe with diluted contrast medium.
2. Attach an inflation device / syringe to the stopcock; attach it to the inflation port
of the product. Do not bend the product hypotube when connecting to the inflation
device / syringe.
3. With the tip down, orient the delivery system vertically.
4. Open the stopcock to delivery system; pull negative for 30 seconds; release to
neutral for contrast fill.
5. Close the stopcock to the delivery system; purge the inflation device / syringe of
all air.
6. Repeat steps 3 through 5 until all air is expelled. If bubbles persist, do not use the
product.
7. If a syringe was used, attach a prepared inflation device to stopcock.
8. Open the stopcock to the delivery system.
9. Leave on neutral.
Note: While introducing the delivery system into the vessel, do not induce negative pressure
on the delivery system. This may cause dislodgement of the stent from the balloon.
Note: If air is seen in the shaft, repeat Section 9.3.3 Delivery System Preparation, steps 3
through 5, to prevent uneven stent expansion.
9.4

Delivery Procedure

1. Prepare the vascular access site according to standard practice.
2. The decision to pre-dilate the lesion with an appropriate sized balloon should be
based on patient and lesion characteristics. If pre-dilatation is performed, limit the
length of pre-dilation by the PTCA balloon to avoid creating a region of vessel injury
that is outside the boundaries of the XIENCE Sierra stent.
3. For long lesions, size the stent to the diameter of the most distal portion of the
vessel.
Note: If choosing between two stent diameters for tight lesions, choose the smaller
diameter stent and inflate. See product label for compliance information.
4. Maintain neutral pressure on the inflation device attached to the delivery system.
Open the rotating hemostatic valve as wide as possible.
5. Backload the delivery system onto the proximal portion of the guide wire while
maintaining guide wire position across the target lesion.
6. Carefully advance the delivery system into the guiding catheter and over the guide
wire to the target lesion. When using a Rapid Exchange (RX) system, be sure to keep
the hypotube straight. Ensure guiding catheter stability before advancing the stent
system into the coronary artery.
Note: If unusual resistance is felt before the stent exits the guiding catheter, do not force
passage. Resistance may indicate a problem and the use of excessive force may result in
stent damage or dislodgement. Maintain guide wire placement across the lesion and remove
the delivery system and guiding catheter as a single unit.
7. Advance the delivery system over the guide wire to the target lesion under direct
fluoroscopic visualization. Utilize the radiopaque balloon markers to position the stent
across the lesion. Perform angiography to confirm stent position. If the position of
the stent is not optimal, it should be carefully repositioned or removed (see Section
9.6 Removal Procedure). The balloon markers indicate both the stent edges and the
balloon shoulders. Expansion of the stent should not be undertaken if the stent is not
properly positioned in the target lesion.
Note: If removal of a stent system is required prior to deployment, ensure that the guiding
catheter is coaxially positioned relative to the stent delivery system, and cautiously withdraw
the stent delivery system into the guiding catheter. Should unusual resistance be felt at any
time when withdrawing the stent towards the guide catheter, the stent delivery system and
the guiding catheter should be removed as a single unit. This should be done under direct
visualization with fluoroscopy.
8. Tighten the rotating hemostatic valve. The stent is now ready to be deployed.
9.5

Deployment Procedure

CAUTION: Refer to product label for in vitro stent inner diameter, nominal pressure,
and RBP.
1. Prior to deployment, reconfirm the correct position of the stent relative to the target
lesion using the radiopaque balloon markers.
2. Deploy the stent slowly by pressurizing the delivery system in 2 atm increments,
every 5 seconds, until stent is completely expanded. Fully expand the stent by
inflating to nominal pressure at a minimum. Accepted practice generally targets an
initial deployment pressure that would achieve a stent inner diameter ratio of about
1.1 times the reference vessel diameter (refer to product label for in vitro stent inner
diameter, nominal pressure, and RBP).
3. For long lesions, size the stent to the diameter of the most distal portion of the
vessel and expand stent to nominal pressure at minimum. Maintain pressure for
30 seconds. If necessary, the delivery system can be repressurized or further
pressurized to assure complete apposition of the stent to the artery wall.
4. Maintain pressure for 30 seconds for full expansion of the stent. Fluoroscopic
visualization during stent expansion should be used in order to properly judge the
optimum stent diameter as compared to the proximal and distal native coronary
artery diameters (reference vessel diameters). Optimal stent expansion and proper
apposition requires that the stent be in full contact with the arterial wall.
Note: See Section 9.6 Removal Procedure for instruction on withdrawal of stent delivery
system.
5. If necessary, the delivery system can be repressurized or further pressurized to
assure complete apposition of the stent to the artery wall.
Note: Do not exceed the labeled rated burst pressure (RBP) of 16 atm (1621 kPa).
6. Fully cover the entire lesion and balloon-treated area (including dissections) with the
XIENCE Sierra stent, allowing for adequate stent coverage into healthy tissue proximal
and distal to the lesion.
7. Deflate the balloon by pulling negative on the inflation device for 30 seconds. Confirm
complete balloon deflation before attempting to move the delivery system. If unusual
resistance is felt during stent delivery system withdrawal, pay particular attention to
guiding catheter position.
Note: See Section 9.6 Removal Procedure for instruction on withdrawal of stent delivery
system.
8. Confirm stent position and deployment using standard angiographic techniques.
For optimal results, the entire stenosed arterial segment should be covered by the
stent. Fluoroscopic visualization during stent expansion should be used in order to
Printed on : 2017-11-03
properly judge the optimum expanded stent diameter as compared to the proximal
and distal coronary artery diameter(s). Optimal expansion requires that the stent be in
full contact with the artery wall. Stent wall contact should be verified through routine
angiography or intravascular ultrasound (IVUS).
9. If the deployed stent size is still inadequate with respect to reference vessel diameter,
a larger balloon may be used to further expand the stent. If the initial angiographic
appearance is suboptimal, the stent may be further expanded using a low profile,
high pressure, noncompliant balloon dilation catheter. If this is required, the stented
segment should be carefully recrossed with a prolapsed guide wire to avoid
disrupting the stent geometry. Deployed stents should not be left underdilated.
CAUTION: Do not dilate the stent beyond the following limits.
Nominal Stent Diameter Dilation Limit
2.0 – 3.25 mm 3.75 mm
3.5 – 4.0 mm 5.50 mm
10. If more than one XIENCE Sierra stent is needed to cover the lesion and balloon-
treated area, it is suggested that, to avoid the potential for gap restenosis, the stents
be adequately overlapped. To ensure that there are no gaps between stents, the
balloon marker bands of the second XIENCE Sierra stent should be positioned inside
the deployed stent prior to expansion.
11. Reconfirm stent position and angiographic results. Repeat inflations until optimal
stent deployment is achieved.
9.6

Removal Procedure

Withdrawal of the stent delivery catheter from the deployed stent:
1. Deflate the balloon by pulling negative pressure on the inflation device. Larger and
longer balloons will take more time (up to 30 seconds) to deflate than smaller and
shorter balloons. Confirm balloon deflation under fluoroscopy and wait 10 to
15 seconds longer.
2. Position inflation device on "negative" or "neutral" pressure.
3. Stabilize guide catheter position just outside coronary ostium and anchor in place.
Maintain guide wire placement across stent segment.
4. Gently remove the stent delivery system with slow and steady pressure.
5. Tighten the rotating hemostatic valve.
If during withdrawal of the stent delivery catheter resistance is encountered, use the
following steps to improve balloon rewrap:
• Re-inflate the balloon up to nominal pressure.
• Repeat steps 1 through 5 above.
Post stent delivery system withdrawal; Stent deployment confirmation
1. Confirm stent position and deployment using standard angiographic techniques.
For optimal results, the entire stenosed arterial segment should be covered by the
stent. Fluoroscopic visualization during stent expansion should be used in order to
properly judge the optimum expanded stent diameter as compared to the proximal
and distal coronary artery diameter(s). Optimal expansion requires that the stent be in
full contact with the artery wall. Stent wall contact should be verified through routine
angiography or intravascular ultrasound (IVUS).
2. If more than one XIENCE Sierra stent is needed to cover the lesion and balloon-
treated area, it is suggested that, to avoid the potential for gap restenosis, the stents
be adequately overlapped.
3. To ensure that there are no gaps between stents, the balloon marker bands of the
second XIENCE Sierra stent should be positioned inside the deployed stent prior to
expansion.
4. Reconfirm stent position and angiographic results to assess stented area. Repeat
inflations until optimal stent deployment is achieved. If post-dilation is necessary,
ensure that the final stent diameter matches the reference vessel diameter. Ensure
that the stent wall is in contact with the artery wall.
9.7

Post-deployment Dilation of Stent Segments

1. All efforts should be taken to ensure that the stent is not under-dilated.
2. If the deployed stent size is still inadequate with respect to the vessel diameter, or
if full contact with the vessel wall is not achieved, a larger balloon may be used to
expand the stent further. The stent may be further expanded using a low profile, high
pressure, and noncompliant balloon catheter. If this is required, the stented segment
should be recrossed carefully with a prolapsed guide wire to avoid dislodging the
stent. The balloon should be centered within the stent and should not extend outside
of the stented region.
CAUTION: Do not dilate the stent beyond the following limits.
Nominal Stent Diameter Dilation Limit
2.0 – 3.25 mm 3.75 mm
3.5 – 4.0 mm 5.50 mm

10.0 SPIRIT AND XIENCE FAMILY OF CLINICAL TRIALS

The XIENCE Sierra EECSS is based on the predicate devices XIENCE V EECSS,
XIENCE PRIME EECSS, XIENCE Xpedition EECSS, and XIENCE Alpine EECSS.
The XIENCE Sierra EECSS uses a similar stent platform, identical drug coating formulation,
identical drug primer, similar nominal total drug content, and the identical stent
contacting balloon materials as the XIENCE PRIME EECSS, XIENCE Xpedition EECSS, and
XIENCE Alpine EECSS.
The XIENCE Sierra EECSS differs from the XIENCE Alpine EECSS in the stent delivery
system. The XIENCE Sierra stent delivery system utilizes the same principle of operation and
materials as other Abbott Vascular RX stent systems and coronary dilatation catheters.
Compared to the XIENCE V EECSS and to the XIENCE PRIME EECSS, the XIENCE Sierra
EECSS has the same stent security specification, same stent placement on the balloon
between the balloon markers, a similar tip entry profile, and a similar taper length for
XIENCE Sierra stent sizes up to 28 mm in length. Based on the similar nature of the
XIENCE Sierra stent to the XIENCE PRIME and XIENCE V stents, performance of the
XIENCE Sierra EECSS can be predicted to be similar to the performance of XIENCE V
and XIENCE PRIME. Therefore, clinical trial data for XIENCE V and XIENCE PRIME are
summarized in this section.