INDICATIONS FOR USE: The MANTA Vascular Closure Device is indicated
for closure of femoral arterial access sites while reducing time to hemostasis following the use
of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.
CONTRAINDICATIONS: There are no known contraindications to the use of this device.
WARNINGS: 1) 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. 2) Do not use in patients with severe calcification of the access vessel and/or common
femoral artery stenosis resulting in a vessel <5mm in diameter for the 14F MANTA or <6mm in
diameter for the 18F MANTA, or>50% diameter femoral or iliac artery stenosis. 3) Do not use in
patients with severe peripheral vascular disease, as evidenced by severe claudication when
ambulating <100 feet, weak or absent pulses in the affected limb, or ABI <0.5 at rest. 4) Do not
use if the temperature indicator dot on package has changed from light gray to dark gray or
black. 5) Do not use if the package is damaged or any portion of the package has been
previously opened. 6) Do not use if the items in the package appear damaged or defective in
any way. 7) 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. 8) 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. 9) Do not use if the MANTA delivery system becomes
kinked. 11) Do not inflate a contralateral balloon in the femoral or iliac artery during MANTA
Sheath exchange or the MANTA Closure procedure. 12) 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. 13) 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 (a) anchor catching on the bifurcation or being positioned incorrectly, and/or
(b) collagen deposition into the vessel. 14) Do not use if there is difficult dilation from
initial femoral artery access (e.g., damaging or kinking dilators) while step dilating up to
the large-bore device. 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. 15) Do not use if sheath insertion is in a
vessel other than the femoral artery. 16) Do not use if there is marked tortuosity of the
femoral or iliac artery. 17) Do not use if the patient has marked obesity or cachexia (BMI>40
kg/m2 or <20 kg/m2). 18) Do not use if the patient has post-procedure blood pressure>180 mmHg
that cannot be lowered prior to access site closure. 19) Do not use in patients who cannot
be adequately anticoagulated for the procedure. 20) Do not use the MANTA Device in patients
with known allergies to bovine products, collagen and/or collagen products, polyglycolic or
polylactic acid polymers, stainless steel or nickel.
PRECAUTIONS: 1) The MANTA Device should only be used by a licensed physician or
healthcare provider trained in the use of this device. 2) This device contains a small
radiopaque stainless-steel lock that is implanted in the puncture tract. See MRI information
in these instructions for use and patient implant card. 3) In the event that bleeding from
the femoral access site persists after the use of the MANTA Device, the physician should
assess the situation. Based on the physician assessment of the amount of bleeding, use
manual or mechanical compression, application of balloon pressure from a secondary access
site, placement of a covered stent, and/or surgical repair to obtain hemostasis.
POTENTIAL ADVERSE EVENTS: The following potential adverse events related to the
deployment of Vascular Closure Devices have been identified: 1) Ischemia of the leg or
stenosis of the femoral artery. 2) Local trauma to the femoral or iliac artery wall, such as
dissection. 3) Retroperitoneal bleeding as a result of access above the inguinal ligament or
the most inferior border of the epigastric artery (IEA). 4) Perforation of iliofemoral
arteries, causing bleeding/hemorrhage. 5) Thrombosis formation or embolism. 6) Nerve damage
or neuropathy. 7) Other access site complications leading to bleeding, hematoma,
pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical
repair, and/or endovascular intervention. Potential Adverse Events associated with any large
bore intervention, including the use of the MANTA Vascular Closure Device, include but are
not limited to: Arterial damage; Arterio-venous fistula; Bradycardia; Compartment syndrome;
Death related to the procedure; Deep vein thrombosis; Ecchymosis; Edema; Infection at the
puncture site which may require antibiotics or extended hospitalization; Inflammatory
response; Late arterial bleeding; Oozing from the puncture site; Pressure in groin/access
site region; Vessel laceration or trauma; Wound dehiscence.
Please see the instructions for use for complete product information.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Not all products are available in all regions. Please contact customer service to confirm
availability in your region.
Teleflex, the Teleflex logo, and MANTA are trademarks or registered trademarks of Teleflex
Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks or
registered trademarks are property of their respective owners.
MC-005197 Rev 0 Revised: 03/2019.