Mri Safety Information; Potential Adverse Events - COOK Medical Gianturco-Roehm Bird's Nest Mode D'emploi

MRI SAFETY INFORMATION

Nonclinical testing has demonstrated that the Gianturco-Roehm Bird's Nest
Vena Cava Filter is MR Conditional according to ASTM F2503. A patient
with this device can be safely scanned after placement under the following
conditions.
• Static magnetic field of 3.0 Tesla or 1.5 Tesla only
• Maximum magnetic field spatial gradient of 1600 gauss/cm (16.0 T/m) or less
• Maximum MR system reported, whole-body-averaged specific absorption
rate (SAR) of ≤ 4.0 W/kg (First Level Controlled Operating Mode) for 15
minutes of scanning or less
Under the scan conditions provided above, the Gianturco-Roehm Bird's Nest
Vena Cava Filter is not expected to result in a temperature rise of more than
3.6 °C after 15 minutes of continuous scanning.
The image artifact extends approximately 75 mm from the Gianturco-Roehm
Bird's Nest Vena Cava Filter as found during nonclinical testing when imaged
with a gradient echo pulse sequence and a 3.0 Tesla MRI system.

POTENTIAL ADVERSE EVENTS

• Access site thrombosis/occlusion
• Air embolism
• Arrhythmia
• Back or abdominal pain
• Blood loss
• Branch vessel occlusion
• Cardiac damage
• Cardiac tamponade
• Coagulopathy
• Damage to the vena cava
• Death
• Deep vein thrombosis
• Extravasation of contrast material
• Failure to adequately deploy
• Filter fracture
• Filter migration
• Filter or filter fragment embolization
• Filter malpositioning
• Hemorrhage
• Hematoma at vascular access site
• Infection at vascular access site
• Intimal tear
• Obstruction of blood flow
• Pneumothorax
• Postphlebitic syndrome
• Pulmonary embolism
• Trauma to adjacent structures
• Vascular trauma
• Vena cava perforation
• Vena cava penetration
• Vena cava occlusion or thrombosis
• Vena cava stenosis
INSTRUCTIONS FOR USE
1. Prep and drape the access site.
2. After infiltration of local anesthesia, make a 3-4 mm skin nick at the
access site, and perform a standard venipuncture using an 18 gage access
needle. (Fig. 1)
3. Introduce a .038 inch (0.97 mm) diameter wire guide and advance it into
the inferior vena cava. (Fig. 2)
4. Leaving the wire guide in place, withdraw the needle. (Fig. 3)
5. Introduce a standard diagnostic catheter and perform an inferior vena
cavogram to localize the renal veins, typically located at the L1-L2
intervertebral space. Once localized, a lead marker taped to the skin at
that level will help to serve as a radiographic landmark to assist precise
filter placement.
6. Over the wire guide, exchange the diagnostic catheter for the filter
introducer sheath assembly. Advance the introducer sheath assembly over
the wire guide to its hub. (Fig. 4)
CAUTION: Do not advance distal end of introducer sheath assembly
beyond distal tip of wire guide.
7. Prepare the filter catheter for introduction by priming its lumen with
contrast medium via its sidearm. Use of a contrast-filled syringe and
flexible connecting tube attached to the stopcock on the filter catheter
sidearm is recommended.
8. Remove the introducer and wire guide from the sheath. (Fig. 5)
9. Insert the filter catheter into the intro ducer sheath and Luer lock it into
position. The tip of the filter catheter will then extend approximately 1.5
cm beyond the tip of the sheath. (Fig. 6) While performing hand injections
of contrast medium through the filter catheter sidearm, the filter catheter/
introducer sheath assembly can be properly positioned to initiate fil ter
placement. When utilizing a femoral approach, position the filter
catheter tip just below (caudad to) the renal veins. (Fig. 7)
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