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Indications and Safety Information

The AngioJet Series 3000 Xpeedior catheter
Is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries > 3.0 mm in diameter and upper extremity and lower infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.

The AngioJet Ultra Xpeedior Thrombectomy Set
Is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:

  • upper and lower extremity peripheral arteries > 3.0mm in diameter,
  • upper extremity peripheral veins > 3.0mm in diameter,
  • ileofemoral and lower extremity veins > 3.0mm in diameter,
  • A-V access conduits > 3.0mm in diameter,
  • for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

CONTRAINDICATIONS
Do not use the Catheter in patients:

  • Who are contraindicated for endovascular procedures;
  • Who cannot tolerate contrast media;
  • In whom the lesion cannot be accessed with the guide wire.

WARNINGS AND PRECAUTIONS

  • The Thrombectomy Set has not been evaluated for treatment of pulmonary embolism. There are reports of serious adverse events, including death, associated with cases where the catheter was used in treatment of pulmonary embolism.
  • The Thrombectomy Set has not been evaluated for use in the carotid or cerebral vasculature.
  • The Thrombectomy Set has not been evaluated for use in the coronary.
  • The AngioJet Ultra System should be used only by operators who have received appropriate training in its installation and use.
  • Operation of the catheter may cause embolization of some thrombus and/or thrombotic particulate debris. Debris embolization may cause distal vessel occlusion, which may further result in hypoperfusion or tissue necrosis.
  • Cardiac arrhythmias during catheter operation have been reported in a small number of patients. Cardiac rhythm should be monitored during catheter use and appropriate management, such as temporary pacing, be employed, if needed.
  • Use of the catheter may cause a vessel dissection or perforation.
  • Do not use the AngioJet Ultra System in patients who have a non-healed injury due to recent mechanical intervention, in the vessel to be treated, to avoid further injury, dissection, or hemorrhage.
  • Do not use the Thrombectomy Set in vessels smaller than 3mm; such use may increase risk of vessel injury.
  • Do not use if sterile package is opened or damaged. The Thrombectomy Set is intended for single use only. Do not resterilize, reprocess or reuse. The AngioJet disposable systems have been designed and qualified for single use only.  Re-use of the system poses risks of device failure and risks to the patient. Potential device failure includes significant component deterioration with extended use, component malfunction, and system operation failure. Potential risks to the patient include injury due to device malfunction or infection due to improper device cleaning or sterilization.
  • Visually inspect the Thrombectomy Set prior to use to ensure that no damage has occurred during shipment. Do not attempt to straighten or use the Thrombectomy Set if it is bent or kinked.  Attempting to do so may result in catheter rupture. Do not use a damaged Thrombectomy Set for patient treatment.
  • Systemic heparinization is advisable to avoid pericatheterization thrombus and acute rethrombosis. This is in addition to the heparin added to the saline supply bag. Physician discretion with regard to the use of heparin is advised.
  • Operation of the AngioJet System causes transient hemolysis which may manifest as hemoglobinuria. The maximum recommended run times are:  in a flowing blood field 5 minutes for the Xpeedior and 4 minutes for the DVX and total operating times for each are 10 minutes for the Xpeedior and 8 minutes for the DVX.  For example, assume that AngioJet is used for 5 minutes to remove thrombus from a completely occluded distal segmet of the femoral vein and then for 3 more minutes to remove non-occluding thrombus in the iliac vein. These run times are consistent with operating times specified in this  recommendation. While the run time to treat the occluded femoral vein segment was longer in this example, more hemolysis can be expected from the treated iliac vein since AngioJet was used in flowing blood.
  • Evaluate the patient’s risk tolerance for hemoglobinemia and related sequelae prior to the procedure. Consider hydration prior to, during, and after the procedure as appropriate to the patient’s overall medical condition.
  • Large thrombus burdens in peripheral veins and other vessels may result in significant hemoglobinemia which should be monitored to manage possible renal, pancreatic or other adverse events.
  • Thrombotic debris/fluid flow exiting the catheter manifold via the waste tubing should be monitored continually during use. If the effluent fluid is primarily saline (clear in appearance), AngioJet Ultra System operation should be stopped and the catheter should be repositioned. Clear fluid indicates that the catheter may be occlusive within the vessel or operating in an area cleared of clot. Prolonged operation under occlusive conditions may result in tissue injury.
  • During the procedure, do not retract the guide wire into the catheter. If retraction of the guide wire into the catheter occurs, it may be necessary to remove both the catheter and guide wire from the patient in order to re-load the catheter over the guide wire.
  • If resistance is felt during the advancement of the Thrombectomy Set to lesion site, do not force or torque the catheter excessively as this may result in deformation of tip components and thereby degrade catheter performance.
  • Do not pull the catheter against abnormal resistance. If increased resistance is felt when removing the catheter, remove the catheter together with the sheath or guide catheter as a unit to prevent possible tip separation.
  • Obstructing lesions that are difficult to cross with the catheter to access thrombus may be balloon dilated with low pressure (< 2 atm). Failure to pre-dilate difficult-to-cross lesions prior to catheter operation may result in vessel injury.
  • Refer to the AngioJet Ultra System Console Operations Manual for other warnings, precautions, and system set-up instructions.
  • The potential for pulmonary thromboembolism should be carefully considered when the Thrombectomy Sets are used
  • to break up and remove peripheral venous thrombus.

ADVERSE EVENTS
Potential adverse events which may be associated with use of the AngioJet Ultra Thrombectomy System are similar to those associated with other interventional procedures and include, but are not limited to:

  • abrupt closure of treated vessel
  • acute myocardial infarction
  • acute renal failure
  • bleeding from access site
  • cerebrovascular accident
  • death
  • dissection
  • thrombosis/occlusion
  • embolization, proximal or distal
  • hematoma
  • hemolysis
  • hemorrhage, requiring transfusion
  • hypotension/hypertension
  • infection at the access site
  • pain
  • pancreatitis
  • perforation
  • pseudoaneurysm
  • reactions to contrast medium
  • thrombosis/occlusion
  • total occlusion of treated vessel
  • vascular aneurysm
  • vascular spasm
  • vessel wall or valve damage