Intended Use; Contraindications - COOK Medical Gianturco-Roehm Bird's Nest Mode D'emploi

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.
WARNINGS
• If severe resistance is met when advancing the wire guide, then retract the
wire guide and choose a different approach.
• Do not rotate the expanded filter hooks inside the vena cava. Doing so may
compromise the performance of the filter.
• Excessive force should not be exerted during placement of the filter.
• Be certain the junction point of the distal pair of hooks is in the catheter
tip when positioning these hooks into the 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 recurrent PE. (With
the Bird's Nest Vena Cava Filter, the observed incidence of recurrent PE 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
reestablishing filter and caval patency.
• If filter migration occurs, transcatheter retrieval of the filter is not
recommended.
• Caval measurement should be performed prior to filter insertion. Additional
attention may be required to ensure adequate fixation of the filter hooks in
venae cavae measuring larger than 40 mm.
• Retroperitoneal hematomas or hemorrhage may occur when the filter is
used in patients receiving thrombolytic therapy.
PRECAUTIONS
• This 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.
• Product (filter or introducer system) modification or alteration is not
recommended, as the product's safety and effectiveness have not been
established following any modifications.
• Manipulation of products (e.g., placement) requires imaging control.
• Possible allergic reactions (e.g., to nickel and/or chromium) should be
considered.
• The use of vena cava filters in pregnant patients and/or placement in the
suprarenal position have been reported. The safety and effectiveness of the
filter have not been established in these patients.
• Filter migration is a known potential complication of vena cava filters.
Cranial (including to the heart and lungs) and caudal migrations have been
reported. Among other causes, migration may be associated with improper
deployment, deployment into clots, dislodgement due to large clot burdens,
and (or) procedures that involve other devices being passed through an in
situ filter.
• Vena cava wall penetration/perforation is a known potential complication
of vena cava filters. Both symptomatic and asymptomatic events have been
reported. Among other causes, vena cava wall penetration/perforation
may inadvertently be initiated by improper deployment, excessive force
or manipulations near an implanted filter (e.g., a surgical procedure in the
vicinity of a filter), and (or) procedures that involve other devices being
passed through an in situ filter.
• Filter fracture is a known potential complication of vena cava filters. Both
symptomatic and asymptomatic events have been reported. Fracture of a
filter hook/hook wire strut can be due to repetitive motion on a filter hook/
hook wire strut in an unusual stressed position. Among other causes, filter
fracture may be associated with a filter hook penetrating/perforating the
IVC, a filter hook being caught in a side branch (e.g., renal vein), excessive
force or manipulations near an implanted filter (e.g., a surgical procedure
in the vicinity of a filter) and (or) procedures that involve other devices
being passed through an in situ filter. It has been reported that retrieval of a
fractured filter or filter fragments using endovascular techniques is possible.
• 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 determine 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.
• For placement of the filter, the right femoral vein is usually preferred due to
its straighter route to the vena cava. The left femoral vein can be used, but is
more tortuous. Prior to choosing an approach, assess the patient's size and
anatomy, and the location of the venous thrombosis.
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