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Suture-Mediated Closure

Prostar XL Percutaneous Vascular Surgical System

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

 

Overview
Knot PusherDesigned for use in 8.5-10F femoral artery access sites.
Features

Close Larger Access Sites Up to 10F

  • Percutaneous vascular closure device

  • Integrated pre-dilator to facilitate device placement

Secure Closure

  • Uses two braided polyester sutures and four nitinol needles to help a secure close

  • Vascular access can be maintained throughout deployment

 Improved Outcomes*

  • Reduces time to hemostasis and ambulation, and early discharge may be appropriate under certain clinical conditions

  • Improves patient comfort and reduces access site complications

 

*Improved outcomes as shown as compared to manual compression.

Ordering Information

Designed for use in 8.5-10F femoral artery access sites following catheterization procedures.

Product Code/ Catalog # 12322

Sold 5 systems per box

Included in Prostar XL 10 System Package: 1 Prostar XL 10, 1 Knot Pusher

  AP2937659-US Rev.A

 

Indications and Important Safety Information

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Prostar® XL

10 French Percutaneous Vascular Surgical System




INDICATIONS

 

The Prostar XL 10F PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS).

CONTRAINDICATIONS


None known.

 

WARNINGS

 

The outer pouch of the Prostar XL PVS System and the individual accessories provides the sterile barrier. Do not use the Prostar PVS System or accessories if the packaging or sterile barrier have been previously opened or damaged, or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Prostar XL PVS System and accessories are intended for single use only.

Do not use the Prostar XL PVS System if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.

PRECAUTIONS

1. The Prostar XL 10F PVS device and accessories should only be used by physicians (or other healthcare professionals authorized by or under the direction of such physicians) after they have been trained in the use of the Prostar XL PVS System and accessories, e.g., participation in a Prostar XL PVS System training program or equivalent.

2. Observe sterile technique at all times when using the Prostar XL PVS System. Employ appropriate groin management post procedure and post hospital discharge to prevent infection.

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

4. Adequate knot security requires accepted surgical technique as warranted by surgical circumstances and the experience of the operator.

5. There are no reaccess restrictions if previous arteriotomy repairs were achieved with an Abbott Vascular Suture Mediated Device.

6. Do not insert the Prostar XL device into the femoral artery at an angle greater than 45 degrees to the longitudinal plane of the artery.

7. Do not advance or withdraw the Prostar XL device against resistance until the cause of that resistance has been determined (see CLINICAL PROCEDURE Device Placement section). Excessive force used to advance or torque the Prostar XL device should be avoided as it may lead to significant arterial damage and/or breakage of the device, which may necessitate intervention and/or surgical removal of the device and arterial repair.

8. If excessive resistance in advancing the Prostar XL device is encountered, withdraw the Prostar XL device over a 0.038” (or smaller) guide wire and reinsert the introducer sheath or use conventional compression therapy.

9. In the event suture breakage occurs after an initial knot has been tied, care should be taken to avoid excessive force if the reintroduction of the Prostar XL device or introducer sheath is required. Any resistance to introduction should result in advancement of an introducer sheath small enough to be introduced without undue force.

10. If significant blood flow is evident through or around the barrel of the Prostar XL device, do not deploy needles. Remove the Prostar XL device over a 0.038” (or smaller) guide wire and insert an appropriately sized introducer sheath.

11. Remove the Prostar XL sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.

12. Do not attempt to re-deploy Prostar XL needles after the needles have been “backed-down” into the sheath (refer to the TECHNIQUE FOR NEEDLE BACK-DOWN section).
13. In the event bleeding from the femoral access site persists after the use of the Prostar XL device and accessories, use conventional compression therapy.

 

ADVERSE EVENTS

 

For a complete list of potential Adverse Events please refer to the Instructions for Use.
The following adverse events have been reported and may occur:

• Device Malfunction • Device Complication • Vascular Repair
• Ultrasound Guided Compression
• Transfusion • Infection Requiring IV Antibiotics • Hematoma > 6 cm • AV Fistula • Nerve Injury
• Pseudoaneurysm


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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