VI. Potential Complications
Procedures requiring percutaneous interventional techniques should not be attempted by physicians
unfamiliar with the possible complications. Complications may occur at any time during the implantation,
indwelling period, or at the time of or following filter retrieval. Possible complications may include, but are
not limited to, the following:
w Vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring
surgical repair or intervention
w Injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention
w Vena cava stenosis or occlusion
w Incorrect positioning or orientation of the filter
w Filter migration/movement
w Extravasation of contrast media
w Vasospasm or decreased/impaired blood flow
w Bleeding or hemorrhagic complications that require transfusion or medical intervention (e.g., IV fluids,
medication)
w Thromboembolic events, including DVT, acute or recurrent pulmonary embolism or air embolism,
possibly causing end organ infarction/damage/failure
w Infection, possibly requiring medical or surgical intervention (e.g. antibiotics or incision and drainage)
w Respiratory insufficiency or failure
w Cardiac arrhythmia
w Myocardial infarction or coronary ischemia
w Cerebrovascular accident or other neurologic event
w Renal insufficiency or failure
w Reaction to contrast media/ medication
w Hematoma, possibly requiring medical intervention or surgical revision
w Other vascular access site injury, including, bruising, AV fistula, or pseudoaneurysm
w Neurological deficit associated with vascular access, possibly requiring nerve intervention or
neurology consultation
w Device breakage or failure or inability to retrieve implanted device as described in IFU, possibly
requiring another intervention or treatment modality to complete procedure
w Death
These events may be serious in nature, and may require hospitalization or intervention to address the
condition.
The Option™ ELITE Filter MUST be placed using either the Standard Percutaneous Procedure or
the Over-the-wire Percutaneous Procedure.
VII. Recommended Percutaneous Procedure for Filter Implantation
Pre-implant cavography is required:
w To confirm the patency and visualize the anatomy of the vena cava.
w To mark the level of the renal veins.
w To locate the highest level of any thrombus which may be present.
w To determine the desired level for filter deployment and to mark the position with respect to the
vertebral bodies.
w To confirm that the diameter of the vena cava (AP projection) at the site where the filter is to be deployed
is less than or equal to the maximum authorized diameter (refer to section I Device Description).
1. Select a suitable venous access site, on either the right or left side, depending upon the patient's size
or anatomy, operator's preference or location of venous thrombosis.
2. Prep, drape and anesthetize the skin puncture site in standard fashion.
3. Remove the components of the introduction kit from the package using sterile technique.
4. Remove the pin and flag from the cartridge prior to use (Figure 6).
Figure 6: Removal of Pin and Flag from Cartridge
5. Wet the operator-selected guidewire (max .038") with sterile heparanized saline or suitable isotonic
solution.
Note: Guidewire is not included in Option™ ELITE Filter Introduction Set. Follow manufacturer's
Instructions for Use.
Use guidewire with minimum 200cm length.
6.
Flush the Catheter Sheath Introducer and Angiographic Vessel Dilator with heparanized saline or
suitable isotonic solution.
7.
Close the side-port after flushing by rotating the stopcock.
8.
Insert the Angiographic Vessel Dilator through the Catheter Sheath Introducer, snapping it into place
at the hub. Flush with heparanized saline or suitable isotonic solution.
9.
Puncture the access site using the Seldinger technique.
10. Holding the needle in place, insert the guidewire through the needle and into the vessel. Gently
advance the guidewire to the desired location.
Caution: Do not withdraw a PTFE-coated guidewire through a metal cannula as this may
damage the guidewire coating.
11. Holding the guidewire in place, remove the needle over the guidewire
12. Advance the Catheter Sheath Introducer together with the dilator over the guidewire and into the
IVC.
13. Position the Catheter Sheath Introducers' radiopaque tip and the marker bands of the Angiographic
Vessel Dilator in the inferior vena cava below the renal veins in preparation for an angiographic
overview of the IVC.
14. Remove the guidewire.
15. Inject contrast media through the Angiographic Vessel Dilator to determine the diameter of the
inferior vena cava at the intended implantation site below the lowest renal vein, using its marker
bands as a reference. The distance between the two marker bands, inside edge to inside edge, is 32mm.
Caution: Do not use with Ethiodol* or Lipiodol contrast media, or other such contrast media
that incorporate the components of these agents.
Caution: Do not exceed 800 psi when injecting.
16. Reintroduce the guidewire.
17. Advance the Catheter Sheath Introducer tip to the desired location in the IVC.
*Ethiodol is a trademark of Guerbet S.A.
