8
•
Vasoconstriction / vasospasm
•
Vasovagal episode
•
Wound dehiscence
10.0
THE PERCLOSE PROGLIDE SMC SYSTEM CLINICAL PROCEDURE
The following instructions provide technical direction but do not obviate the
necessity of formal training in the use of the Perclose ProGlide SMC System.
The techniques and procedures described below are not intended as a substitute
for the operator’s experience and judgment in treating any specific patients.
10.1
Examination and Selection of Products
1. Select the Perclose ProGlide SMC device(s) for closure of 5F to 21F
introducer sheath access sites.
2. After carefully inspecting the packaging of the Perclose ProGlide SMC device
and accessories for damage to the sterile barrier, remove the device from
the package.
3. Exercise care when using additional instruments, such as clamps, forceps or
needle holders during device handling, to reduce the possibility of accidental
device breakage or damage to the suture.
4. Verify marker lumen patency by flushing the marker lumen with saline until
the saline exits the marker port.
Do not use the Perclose ProGlide SMC
device if the marker lumen is not patent.
10.2
Arterial Site and Puncture Considerations
1. An extremely deep tissue tract can influence needle trajectory, which prevents
the Perclose ProGlide SMC device needles from engaging the cuffs, or secure
knot tying, as the Suture Trimmer may not be able to advance the knot to the
arterial wall for complete apposition before locking the knot. An extremely
deep tissue tract may require a long access needle and / or upon inserting the
Perclose ProGlide device, requires compression of the subcutaneous tissue
(with the handle of the device) to be able to obtain pulsatile flow.
2. Before inserting the access needle, use of ultrasound guidance to visualize
the common femoral artery or fluoroscopy to visualize the femoral head is
recommended. When using the femoral head as a reference point, target
the middle of the femoral head as the puncture site. Performing a femoral
angiogram through the introducer sheath (or procedural sheath) to verify that
the access site is in the common femoral artery is recommended before
anticoagulants are given.
3. Puncture the anterior wall of the common femoral artery at an angle of
approximately 45 degrees. Avoid side wall or posterior wall femoral artery
punctures.
4. Prior to deployment of the Perclose ProGlide SMC device, perform a femoral
angiogram to evaluate the femoral artery site for vessel size, calcium deposits,
tortuosity, and for disease or dissections of the arterial wall to avoid device
cuff misses (device needles not engaging with the cuffs) and / or posterior
wall suture placement and possible ligation of the anterior and posterior walls
of the femoral artery. The puncture should be proximal to the bifurcation of the
superficial femoral artery and the profunda femoris branch and distal to the
inferior margin of the inferior epigastric artery.
5. There are
no
femoral artery reaccess restrictions after using Abbott Vascular
closure devices.
10.3
SMC Device Placement 5F–8F Sheath, including Optional
Pre-Close and Maintaining Wire Access Techniques
The following instructions detail the deployment sequence to close the
access site of a catheterization procedure performed through a 5F to 8F
sheath size.
1. Place a 0.038” (0.97 mm) (or smaller) guide wire through the procedural (or
introducer) sheath. Remove the procedural sheath while applying pressure on
the groin to maintain hemostasis.
2. Backload the device over the guide wire until the guide wire exit port of the
device sheath is just above the skin line. Remove the guide wire before the
exit port crosses the skin line.
3. Continue to advance the device just until brisk pulsatile flow of blood is
evident from the marker lumen. Position the device at a 45-degree angle.
Deploy the foot by lifting the lever
(marked #1)
on the top of the handle.
Do
not deploy the foot unless brisk pulsatile flow of blood (“mark”) is evident
from the marker lumen.
4. Gently pull the device back to position the foot against the arterial wall. If
proper position of the foot has been achieved, tactile sensation will be felt
AND
blood marking will cease or be significantly reduced to a slight drip. If
marking does not stop or significantly change, evaluate the angiogram for
femoral artery size, calcium deposits, tortuosity, disease and for location of
the puncture (ensure footplate is not in bifurcation or side branch). Reposition
the device to stop blood marking or reinsert the wire, remove the device to
hold manual compression or insert a new sheath.
5. While maintaining device position, stabilize the device with your free hand
(the one not used to deploy the device) to maintain the gentle retraction and
to ensure the device does not twist or move forward during deployment. Use
your other hand to deploy needles by pushing on the plunger assembly
(in the
direction marked #2)
until you visually confirm that the collar of the plunger
makes contact with the proximal end of the body. Do not use excessive force
or repeatedly push the plunger assembly. After visually confirming contact with
the body of the device only
one time,
this step is complete.
6. Using your thumb as a fulcrum on the handle, gently disengage the needles
by pulling the plunger assembly back
(in the direction marked #3)
and
completely remove the plunger and needles from the body of the device. One
suture limb will be attached to the anterior needle. The posterior needle will be
free of suture. Pull back on the plunger until the suture is taut, which confirms
that all the sutures have been fully retracted from the body of the device.
7. Do not attempt to redeploy the needles if the suture limb is not attached to the
anterior needle. Reinsert the guide wire, and remove the device over the wire.
Insert a new Perclose ProGlide SMC device to complete the procedure.
•
In using this or any other suture material, care should be taken to avoid
damage from handling. Avoid crushing damage due to application of
surgical instruments such as clamps, forceps or needle holders.
•
For closure of arteriotomy sites using a 5F–8F procedural sheath, use
manual compression in the event bleeding from the femoral access site
persists after the use of the Perclose ProGlide SMC device.
•
For closure of arteriotomy sites using an 8.5F–21F procedural sheath,
depending on the type of interventional catheterization procedure, use
manual compression methods, compression assisted devices, and / or other
appropriate treatment methods in the event bleeding from the femoral access
site persists after the use of Perclose ProGlide SMC devices.
8.0
SPECIAL PATIENT POPULATIONS
The safety and effectiveness of the Perclose ProGlide SMC devices have not
been established in the following special patient populations:
•
Patients with introducer sheaths < 5F or > 21F during the catheterization
procedure.
•
Patients with small femoral arteries (< 5 mm in diameter).
•
Patients with access sites above the most inferior border of the inferior
epigastric artery (IEA) and / or above the inguinal ligament based upon
bony landmarks.
•
Patients having arterial access in vessels other than the common femoral
artery.
•
Patients having a hematoma, pseudoaneurysm or arteriovenous fistula
present prior to sheath removal.
•
Patients with femoral artery calcium which is fluoroscopically visible at
access site.
•
Patients with severe claudication, iliac or a femoral artery diameter
stenosis greater than 50% or previous bypass surgery or stent placement
in the vicinity of access site.
•
Patients with access sites in vascular grafts.
•
Patients with prior intra-aortic balloon pump at access site at any time
prior.
•
Patients with ipsilateral femoral venous sheath during the catheterization
procedure.
•
Patients with ipsilateral arterial access sites punctured and compressed
within 48 hours of closure.
NOTE:
The previous / initial puncture site
may have the potential to re-bleed due to an unstable clot and / or
anticoagulants, even if the new puncture site is successfully closed with a
Perclose ProGlide SMC device.
•
Patients where there is difficulty inserting the introducer sheath or greater
than one ipsilateral arterial puncture at the start of the catheterization
procedure.
•
Patients with antegrade punctures.
•
Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the
catheterization procedure.
•
Patients who are pregnant or lactating.
•
Patients with bleeding diathesis or coagulopathy.
•
Patients younger than 18 years of age.
•
Patients who are morbidly obese (Body Mass Index ≥ 40 kg/m
2
).
•
Patients with active systemic or cutaneous infection or inflammation.
Before considering early discharge, assess the patient for the following clinical
conditions:
•
Conscious sedation
•
Anticoagulation, thrombolytic, or antiplatelet therapy
•
Unstable cardiac status
•
Hematoma at the closure site
•
Hypotension
•
Pain while walking
•
Bleeding at the closure site
•
Any comorbid condition requiring observation
The presence of any of the above factors has generally led to the deferral of
early discharge recommendations.
9.0
POTENTIAL ADVERSE EVENTS
Potential complications associated with the use of suture-mediated closure
devices may include, but are not limited to, the following:
•
Allergic reaction or hypersensitivity to device components
•
Anemia
•
Arterial stenosis / occlusion
•
Arteriovenous fistula
•
Bleeding / hemorrhage
•
Bruising / hematoma
•
Death
•
Deep vein thrombosis
•
Device entrapment
•
Device failure / malfunction / misplacement
•
Diminished pulses distal to closure site
•
Embolism
•
Extended hospitalization / delayed time to ambulation
•
Infection / sepsis
•
Inflammation
•
Intimal tear / dissection
•
Ischemia distal to closure site
•
Nerve injury
•
Numbness
•
Pain
•
Perforation
•
Retroperitional hematoma / bleeding
•
Surgical exposure / closure of common femoral artery
•
Thrombus formation
•
Vascular injury
RELEASED
RELEASED
