INSTRUCTIONS FOR USE - MANTA
LBL-001 REV. A 2018/01
3
DEVICE DESCRIPTION
The MANTA Vascular Closure Device consists of the MANTA Closure, an Insertion Sheath with Introducer, and a Puncture Locating Dilator. The MANTA
Closure is composed of a delivery handle containing an absorbable collagen pad, a stainless steel locking component, and an absorbable polymer toggle
that are connected by a non-absorbable suture. Hemostasis is achieved primarily by the mechanical means of the toggle-arteriotomy-collagen sandwich,
which is supplemented by the coagulation-inducing properties of the collagen. The extra-vascular stainless steel lock secures and marks the location of the
absorbable unit. The MANTA Vascular Closure Device components are not made from latex rubber.
INDICATIONS
The 14F MANTA is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the
18F MANTA device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths
(maximum OD/profile of 25F).
CONTRAINDICATIONS
The MANTA Device is contraindicated in the following:
•
Severe calcification of the access vessel.
•
Severe peripheral artery disease.
•
Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery
(IEA).
•
Sheath insertion in vessel other than the femoral artery.
•
Marked tortuosity of the femoral or iliac artery.
•
Marked obesity or cachexia (BMI >40 or <20).
•
Blood pressure > 180 mmHg.
•
Patients who cannot be anti-coagulated for the procedure.
WARNINGS
•
Do not use if the temperature indicator dot on package has changed from light gray to dark gray or black.
•
Do not use if the package is damaged or any portion of the package has been previously opened.
•
Do not use if the items in the package appear damaged or defective in any way.
•
Do not REUSE or RESTERILIZE. The MANTA Device is single use only. The MANTA Device contains bioresorbable materials that cannot be
reused or re-sterilized. Reuse or re-sterilization may cause degradation to the integrity of the device, leading to device failure which may
result in patient injury, illness, or death.
•
Do not use the MANTA Device where bacterial contamination of the procedure sheath or surrounding tissues may have occurred, as this
may result in infection.
•
Do not use if the procedure sheath has been placed through the superficial femoral artery and into the profunda femoris artery, as this may
result in collagen deposition into the superficial femoral artery.
•
Do not use if the MANTA delivery system becomes kinked.
•
Do not inflate a contralateral balloon in the femoral or iliac artery during MANTA Sheath exchange or the MANTA Closure procedure.
•
Do not use MANTA if there has been a femoral artery puncture in same vessel within the prior 30 days, recent femoral artery puncture in
same groin that has not healed appropriately, and/or recent (<30 days) vascular closure device placement in same femoral artery.
•
Do not use if the puncture site is at or distal to the bifurcation of the superficial femoral and profunda femoris artery, as this may result in
the 1) toggle catching on the bifurcation or being positioned incorrectly, and/or 2) collagen deposition into the vessel.
•
Do not use if the puncture site is proximal to the inguinal ligament or above the most inferior border of the epigastric artery (IEA), as this
may result in retroperitoneal bleeding.
•
Difficult dilation of the puncture tract due to scar tissue may lead to swelling of surrounding tissue, thus compromising the accuracy of the
puncture depth determined during the puncture location procedure.
PRECAUTIONS
•
The MANTA Device should only be used by a licensed physician or healthcare provider trained in the use of this device.
•
The MANTA Device should not be used in patients with known allergies to bovine products, collagen and/or collagen products, or
polyglycolic or polylactic acid polymers.
•
The MANTA Device should not be used in patients with known allergy to stainless steel or nickel. See MRI information in these instructions
for use.
ADVERSE EVENTS
The following potential adverse events related to the deployment of Vascular Closure Devices have been identified:
•
Failed hemostasis requiring manual or mechanical compression, application of balloon pressure from a secondary access site, placement of
a covered stent or surgical repair.
•
Local trauma to the femoral or iliac artery wall, such as dissection.
•
Retroperitoneal bleeding as a result of access above the inguinal ligament or the most inferior border of the epigastric artery (IEA).
•
Perforation of ileofemoral arteries, causing bleeding/hemorrhage.
•
Accidental positioning of some or all of the collagen plug within the femoral artery, leading to ischemia or stenosis.
•
Thrombosis formation or embolism.
•
Nerve damage or neuropathy.
•
Other access site complications leading to bleeding, hematoma, pseudoaneurysm, etc., possibly requiring blood transfusion, surgical repair,
and/or endovascular intervention.
SPECIAL PATIENT POPULATIONS
The safety and effectiveness of the MANTA Device has not been established in the following patient populations:
•
Patients undergoing an interventional procedure who are being treated with warfarin.
•
Patients with pre-existing autoimmune disease.
•
Patients undergoing therapeutic thrombolysis.
•
Patients punctured through a vascular graft.
•
Patients with uncontrolled hypertension (>180 mm Hg systolic).
•
Patients with a bleeding disorder, including thrombocytopenia (< 100,000 platelet count), thrombasthenia, von WilleBrand’s disease, or
anemia (Hgb<10 g/dl, Hct<30).
•
Pediatric patients or others with small femoral artery size <5mm (for 14F MANTA) or <6mm (for 18F MANTA) in diameter.
•
Patients who are pregnant or lactating.
•
Patients on continuous oral anticoagulants.
PROCEDURE REQUIREMENTS
The MANTA Device is to be used only by a licensed physician (or other health care professional authorized by or under the direction of such physician)
possessing adequate instruction in the use of the device.
Arterial access should be gained using micro-puncture technique using ultrasound guidance to puncture the midline of the femoral artery. Do not puncture
the posterior wall of the artery.
Anti-coagulation should be administered at procedure initiation per the hospital’s standard of care.
Activated clotting time (ACT) should be below 250 seconds prior to closure.
Puncture location using the supplied Puncture Locating Dilator must occur prior to step dilation of the vessel and before the large-bore procedure is
performed.
If a patient has had a procedure sheath left in place for longer than 6 hours, consideration should be given to the use of prophylactic antibiotics before
insertion of the MANTA Device.
Observe sterile technique at all times when using the MANTA Device. Repeat application of an appropriate skin preparation solution to existing sheath and
surrounding area. Refresh drapes and operator gloves as appropriate.
The MANTA Device is for single use only and should not be reused in any manner.
MANTA Sheath placement must be performed utilizing the MANTA Introducer provided in the system.
The MANTA Closure must be deployed using the MANTA Sheath provided in the MANTA package. Do not substitute any other sheath.
If the MANTA Closure does not deploy properly in the artery and hemostasis is not achieved, the closure and all absorbable components may be removed
from the patient if medically necessary.
Dispose of contaminated device, components, and packaging materials utilizing standard hospital procedures and universal precautions for bio hazardous
waste.
The collagen utilized in the MANTA vascular closure device is a non-viable, highly-purified derivative from bovine hide and undergoes substantial chemical
processing to purify while ensuring physical integrity. With the exception of those patients with allergies to beef or collagen products, the collagen found
in the MANTA device will not elicit a reaction to surrounding body tissue or standard materials used during the endovascular procedure. The physician
should inform the patient of the aforementioned information that the collagen plug will be resorbed in several months.
HOW SUPPLIED / DEVICE COMPONENTS
The MANTA Device system is supplied sterilized and sealed with a poly-
foil pouch in a tray containing the following supplies:
1 each 14F or 18F MANTA Sheath
1 each 14F or 18F MANTA Closure
1 each 14F or 18F MANTA Introducer
1 each Puncture Locating Dilator
PROCEDURE PREPARATION
Confirm via femoral arteriogram:
•
Single wall puncture in the common femoral artery.
•
Vessel size
≥
6mm for 18F and
≥
5 for 14F and evidence of
adequate blood flow.
•
No evidence of significant peripheral vascular disease or
calcification in the region of the arteriotomy.
DEVICE USE STEPS
Figure 1 – MANTA Device Components
Before step dilation and large-bore procedure
Step 1: Arteriotomy Location Procedure
Prior to step-dilating the artery, the Puncture Locating Dilator must be used to locate the vessel wall.
•
Flush Puncture Locating Dilator with sterile heparinized saline to ensure good puncture locating blood flow.
•
Insert the Puncture Locating Dilator over a 0.035” guidewire.
•
Advance the Puncture Locating Dilator over the guidewire and fully into the vessel. A steady flow of blood will be visible jetting perpendicular
to the Dilator at the proximal end.
•
Using your left hand to keep the skin at a neutral position, slowly withdraw the Puncture Locating Dilator from the vessel until blood flow
ceases. Note the first visible marking near the skin puncture (Figure 2). The mark will be either a whole number or a dot. A dot signifies
the half centimeter mark between whole numbers. Add one (1) cm to this number/marker to arrive at the proper deployment depth for
the MANTA closure.
o
NOTE: If blood flow ceases deeper than 9.5cm, the vessel is too deep to use MANTA. DO NOT use the MANTA device.
•
Advance the Puncture Locating Dilator fully into the vessel once again.
Keeping the skin at a neutral position, withdraw the dilator slowly.
Confirm steady blood flow at the deployment depth (measured depth plus
one (1) cm). Continue to withdraw the dilator until blood flow ceases.
Confirm to previous measurement.
•
If blood flow ceases at a different depth, repeat the full insertion and
withdraw step (blood flow ceases) and one (1) cm advancement (blood
flow is visible) of the Puncture Locating Dilator to confirm puncture
location.
MANTA Deployment Depth = flow stop measurement at skin + one (1) cm
NOTE: The deployment depth will correspond to a MANTA Sheath marking when
positioning the MANTA closure device for toggle release in Step 4.
Figure 2 – Using the Puncture Locating Dilator to determine puncture
depth prior to large-bore procedure
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