Intended Use; Contraindications; Potential Adverse Events - COOK Medical BIRD'S NEST Gebrauchsanweisung

INTENDED USE

The Gianturco-Roehm Bird's Nest Vena Cava Filter is intended for the
prevention of recurrent pulmonary embolism via placement in the vena cava
in the following situations:
1. Pulmonary thromboembolism when anticoagulants are contraindicated;
2. Failure of anticoagulant therapy in thromboembolic diseases;
3. Emergency treatment following massive pulmonary embolism where
anticipated benefits of conventional therapy are reduced;
4. Prophylactically in patients with chronic, recurrent pulmonary embolism
where anticoagulant therapy has failed or is contraindicated.

CONTRAINDICATIONS

• Vena cava filters should not be implanted in patients with risk of septic
embolism.
• The Bird's Nest Filter should not be used in patients with a vena cava larger
than 40 mm diameter.
WARNINGS
• Be certain the junction point of distal pair of hooks is in catheter tip when
positioning these hooks into caval wall. If there is uncertainty regarding
hook fixation, the catheter may be advanced up over the hook wires to the
edge of the hooks. The catheter may then be repositioned, and the filter
placement re-initiated in a slightly different caval orientation or level.
• No technique will completely eliminate the possibility of recur rent PTE. (With
the Bird's Nest Vena Cava Filter, the observed incidence of recurrent PTE is
clinically acceptable.)
• The Bird's Nest Vena Cava Filter is non-thrombogenic, but may occlude if it
traps a large volume of embolic material in a short time period. Thrombolytic
agents administered via femoral venipunctures have been successful in re-
establishing filter and caval patency.
• If filter migration occurs, transcatheter retrieval of the filter is not
recommended.
• Retroperitoneal hematomas or hemorrhage may occur when filter is used in
patients receiving thrombolytic therapy.
PRECAUTIONS
• The product is intended for use by physicians trained and experienced
in diagnostic and interventional techniques. Standard techniques for
placement of vascular access sheaths, angiographic catheters, and wire
guides should be employed.
• Insertion requires the use of fluoroscopy. Only those physicians skilled
in the use of fluoroscopic images should attempt filter insertion. Read and
follow the enclosed instructions carefully.
• Do not remove the preloaded filter from the catheter. Attempts to
reload may damage the catheter or the filter.
• An effort should be made prior to filter placement to deter mine if emboli
are coming from the lower extremities. The filter is not effective in filtering
emboli from a superior or cardiac source if placed in the inferior vena cava.
MAGNETIC RESONANCE IMAGING
MRI-Safe: No additional risk to the patient, but may affect the quality of the
diagnostic information if scanning in the area of the filter. MRI diagnostic
procedures should be postponed for 6 weeks following filter implantation to
assure device incorporation into the vessel wall.

POTENTIAL ADVERSE EVENTS

• Damage to the vena cava
• Pulmonary embolism
• Filter embolization
• Vena cava perforation
• Vena cava occlusion or thrombosis
• Hemorrhage
• Hematoma at vascular access site
• Infection at vascular access site
• Death
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.
9
Illustrations