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VortX™ 18 and 35 Vascular Occlusion Pushable Coils

Indications, Safety and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

VortX-18 Fibered Platinum Coil

INTENDED USE/INDICATIONS FOR USE

Boston Scientific’s 0.018 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

The Coil Pusher-16 is intended to be used in conjunction with a microcatheter to deliver and deploy 0.018 pushable occlusion coils.

CONTRAINDICATIONS

None known.

PRECAUTIONS

  • The long-term effect of this product on extravascular tissues has not been established, so care should be taken to retain this device in the intravascular space.
  • Do not advance the coil with force if the coil becomes lodged within the microcatheter. Determine the cause of resistance and replace the microcatheter and the coil when necessary.
  • Replace the microcatheter if increased resistance is noted during coil delivery.

ADVERSE EVENTS

The complications that may result from a peripheral embolization procedure include, but are not limited to:

  • Complications related to catheterization (e.g., hematoma at the site of entry, vessel injury, etc.)
  • Death
  • Emboli
  • Foreign body reactions necessitating medical intervention
  • Hemorrhage
  • Infection necessitating medical intervention
  • Ischemia
  • Pain
  • Recanalization
  • Temporary neurological deficit
  • Tissue necrosis
  • Undesirable clot formation of the vasculature
  • Vasospasm

VortX-35 Fibered Platinum Coil

INTENDED USE/INDICATIONS FOR USE

VortX - 35 and 2D Helical - 35 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.

CONTRAINDICATIONS

None known.

WARNINGS

Never advance the guidewire after coil has been deposited. Advancing the guidewire after the coil has been deposited risks damaging the vessel.

PRECAUTIONS

In preclinical studies, the use of this device has been associated with a minor chronic inflammation of a giant cell foreign body reaction. Although inflammation of this type has not been observed in humans, the long term clinical significance of this type of inflammatory response, if any, is unknown. The long term effect of this product on extravascular tissues has not been established, so care should be taken to retain this device in the intravascular space. Do not advance the coil with force if the coil becomes lodged within the catheter. Determine the cause of resistance and replace the catheter and the coil when necessary. Replace catheter frequently if increased resistance is noted during coil delivery.

ADVERSE EVENTS

The complications that may result from a peripheral embolization procedure include, but are not limited to:

  • Complications related to catheterization (e.g., hematoma at the site of entry, vessel injury, etc.)
  • Death
  • Emboli
  • Foreign body reactions necessitating medical intervention
  • Hemorrhage
  • Infection necessitating medical intervention
  • Ischemia
  • Pain
  • Recanalization
  • Temporary neurological deficit
  • Tissue necrosis
  • Undesirable clot formation of the vasculature
  • Vasospasm
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