VortX-18 and VortX-35 Vascular Occlusion Coils Prescriptive Information
VortX-18
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
VortX™ — 18, VortX™ 18 Diamond Shaped, Straight — 18, Figure 8 — 18, Multi-Loop — 18, Complex Helical – 18 Fibered Platinum Coils, Coil Pusher — 16
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 used in conjunction with a microcatheter to deliver and deploy 0.018 pushable occlusion coils.
Contraindications
None known
Adverse Events
Potential complications include but are not limited to:
- hematoma at the site of entry
- vessel perforation
- emboli
- hemorrhage
- ischemia or vasospasm
- clot formation at tip of catheter & subsequent dislodgement
- nerve and vessel dissection & perforation
- pain
- infection necessitating medical intervention
- claudication
- tissue necrosis
- undesirable clot formation of the vasculature
- foreign body reactions necessitating medical intervention
Warnings
- Recanalization has been observed with the usage of some coils. Angiographic follow-up is recommended to ensure continued occlusion.
- To date, there have been no reports of adverse events associated with MRI procedures conducted on patients with platinum coils in their peripheral vasculature. However, compatibility with Magnetic Resonance Imaging (MRI) has not been established, and the degree of imaging distortion resulting from the coil has not been measured.
- Never advance the coil pusher after the coil has been deployed to avoid risk of damaging the vessel. If vessel damage occurs follow institutional protocols.
Precautions
- Compatibility with microcatheters other than the Boston Scientific 0.53 mm (0.021 in) lumen I.D. microcatheters has not been established.
- Do not use microcatheters, coil pushers or coils that have been damaged in any way.
- 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.
- Check that all fittings are secure so that air is not introduced into the guiding or microcatheters during continuous flush.
- Verify that the distal shaft of the microcatheter is not under stress before coil deployment. Axial compression or tension forces may be stored in the microcatheter causing the tip to
move during coil delivery.
- If resistance is encountered when withdrawing the coil pusher, draw back on the microcatheter simultaneously until the coil pusher can be removed without resistance.
- 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.
- All injections should be delivered in a slow, controlled fashion to avoid a change in coil position.
- Replace the microcatheter if increased resistance is noted during coil delivery.
VortX-35
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Fibered Platinum Coils .035” Type and VortX-35
Intended Use / Indications for Use
Fibered Platinum Coils, .035" Type and VortX-35 Coils are intended for arterial and venous embolizations in the peripheral vasculature.
Potential Adverse Effects
Potential complications include but are not limited to: hematoma at the site of entry, vessel perforation or rupture, emboli, hemorrhage, ischemia or vasospasm, neurological deficits
including stroke and possibly death.
Warnings
- Never advance the guidewire after coil has been deposited. Advancing the guidewire after the coil has been deposited risks damaging the vessel.
- To date, there have been no reports of adverse events associated with Magnetic Resonance Imaging (MRI) procedures conducted on patients with platinum coils in their
neurovasculature. However, compatibility with MRI has not been established, and the degree of imaging distortion resulting from the coil has not been measured.
- 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. Therefore, we do not recommend that this device be used for
permanent occlusion.
- 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.
- Multiple embolization procedures may be required to achieve the desired occlusion of some vessels.
Precautions
- Do not use if sterile package has been breached or damaged. After use, dispose in accordance with hospital, administrative, and/or local government policy.
- Check that all fittings are secure so that air is not introduced into the guiding or delivery catheter during continuous flush.
- Verify repeatedly that the distal shaft of the coil delivery catheter is not under stress before coil deployment. Axial compression or tension forces may be stored in the catheter
causing the tip to move during coil delivery.
- The use of high quality, digital subtraction fluoroscopic road mapping helps to monitor the catheter position in relation to vessel bifurcations and is a useful tool in the selection of
the appropriate delivery site and the corresponding coil size.
- 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.
- If resistance is encountered when withdrawing the 0.035 in (0.89 mm) guidewire, draw back on the catheter simultaneously until the guidewire can be removed without
resistance.
- Contrast medium may cause the coil to change its position. All injections should be made in a slow, controlled fashion.
- Replace catheter frequently if increased resistance is noted during coil delivery.
