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Clip Closure

StarClose SE Vascular Closure System

Indications & Important Safety Information ›› IFU (Full Version) ››
 
Overview

 

The safe, easy, and extravascular solution for vascular closure of 5-6F femoral artery access sites.

starclose-se

StarClose SE

Features
Safe
  • Mechanical closure- hemostasis is not clot dependent and can be challenged and confirmed on the table
  • MRI Conditional- patients can safely undergo MRI immediately following implantation under conditions specified in the IFU

Easy

  • Instructions include four clicks to close
  • Numbered windows and numbered steps provide visual guidance for step completion

Extravascular

  • Designed not to impact lumen diameter or distal blood flow
  • Proprietary nitinol design – nothing remains inside the artery*

 

 

 

*Data on file at Abbott Vascular.

Ordering Information
Designed for use in 5 to 6F access sites following diagnostic or interventional catheterization procedures

 

Product Code/ Catalog # 14679

Sold 10 systems per box

Included in StarClose SE System Package: 1 Clip Applier, 1 6F Exchange Sheath, 1 6F Dilator, 1 .038" J-Tip Guidewire

 

 

  AP2937661-US Rev. B

 

Indications and Important Safety Information

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StarClose SE®

Vascular Closure System

 

INDICATIONS

 

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 times 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 SE 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 SE Vascular Closure System and accessories are intended for single use only.

Do not use the StarClose SE 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 SE 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 SE 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 SE 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.


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

∙ Access site-related bleeding requiring ≥ 30 minutes to re-achieve hemostasis

∙ Localized access site infection treated with IM or oral antibiotics ∙ UADE


Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events

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