StarClose SE®

Vascular Closure System

INDICATIONS FOR USE

The StarClose Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.

The StarClose Vascular Closure System is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement.

The StarClose Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing time to hemostasis and ambulation in patients who have undergone interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.

CONTRAINDICATIONS

The StarClose SE Vascular Closure System is contraindicated for use in patients with known hypersensitivity to nickel-titanium.

WARNINGS

Do not use the StarClose Vascular Closure System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The StarClose Vascular Closure System and accessories are intended for single use only.

Do not use the StarClose Vascular Closure System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the StarClose Vascular Closure System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site.

Do not use the StarClose Vascular Closure System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a retroperitoneal hematoma.

Do not use the StarClose Vascular Closure System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site.

PRECAUTIONS

1. The StarClose SE Vascular Closure System should be used only by operators trained in diagnostic and interventional catheterization procedures who have been certified by an authorized representative of Abbott Vascular Inc.

2. The StarClose SE Vascular Closure System is provided sterile and non-pyrogenic in unopened undamaged packaging. Products are sterilized with ethylene oxide and intended for single use only. Do not resterilize. Store in a cool, dry place.

3. Prior to use, inspect the StarClose SE Vascular Closure System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.

4. As with catheter based procedures, infection is a possibility. Observe sterile technique at all times when using the StarClose SE Vascular Closure System. Employ appropriate groin management post procedure and post hospital discharge to prevent infection.

5. Use a single wall puncture technique. Do not puncture the posterior wall of the artery.

6. Do not use the StarClose SE Vascular Closure System to close vessels with diameters less than 5 mm.

7. Do not deploy the Clip in areas of calcified plaque.

8. The StarClose SE Vascular Closure System can be used ONLY with the StarClose Exchange System (included in the StarClose SE Vascular Closure System packaging).

9. Do not advance or withdraw the StarClose SE Vascular Closure device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the StarClose SE device should be avoided, as this may lead to significant vessel damage and/or breakage of the device, which may necessitate interventional and/or surgical removal of the device and vessel repair.

Refer to Instructions for Use for additional Precaution information.

ADDITIONAL CONSIDERATION

The StarClose Clip has shown to be MRI conditional immediately following implantation.  A patient with this implant can be scanned safely immediately after clip placement under the following conditions:  Static magnetic field of 3-Tesla or less, Spatial gradient magnetic field of 720-Gauss/cm or less, Maximum MR system reported whole body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning.

In non-clinical testing, the StarClose clip produced a temperature rise of 0.5ºC maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of MR scanning in a 3-Tesla MR system using a transmit/receive body coil.

The MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the StarClose clip.  Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary.

ADVERSE EVENTS

Potential adverse events that could be associated with use of this device include:

• Major Vascular Complications: Vascular Injury Requiring Repair , Surgery, Angioplasty, Ultrasound Guided Compression, Thrombin injection or Other Percutaneous Procedure, New Ipsilateral Lower Extremity Ischemia,  Access Site-related Bleeding Requiring Transfusion, Access Site-related Infection Requiring Intravenous Antibiotics or Prolonged Hospitalization , Access Site-related Nerve Injury Requiring Intervention, Death

• Minor Vascular Complications: Pseudoaneurysm, Arteriovenous Fistula, Hematoma (≥ 6 cm), Late access site-related bleeding, Transient lower extremity ischemia , Ipsilateral deep vein thrombosis. Transient access site-related nerve injury , Access site-related vessel injury ,  Access site wound dehiscence, Ultrasound guided Thrombin Injection, Re-bleeding at time of first ambulation, requiring ≥ 30 min. for re-hemostasis, Access site-related bleeding requiring ≥ 30 minutes to re-achieve hemostasis, Ipsilateral lower extremity arterial emboli, transient loss of ipsilateral lower extremity pulse. Access site-related vessel laceration. Localized access site infection treated with IM or oral antibiotics

REPUNCTURE THROUGH STARCLOSE CLIP

The safety of repuncture at any time through any part of a previously deployed StarClose Clip, and the safety of subsequent closure of this repuncture using the StarClose Vascular Closure System, have not been fully established. The following information is provided to assist the operator in assessing the possible risks that may be associated with such repuncture and repuncture closure, which include Clip dislodgement, Clip embolization, and bleeding. Studies were performed in a simulated setting because a clinical trial would not be adequate in testing the worst case scenario since the likelihood of hitting the Clip in the clinical setting is very low. Please consult IFU for complete information regarding the studies performed.