COOK Medical I-IGTCFS-426-08 Instructions For Use Manual page 11

tilt >15°) was observed in six patients based on
venographic images taken after filter placement.
Among patients in Registry A, the MAE rate was 3%
(1/34); one patient experienced a PE. Among patients
in Registry B, the MAE rate was 2.1% (2/95); two
patient deaths were CEC adjudicated as potentially
device-related, one was within 24 hours of the
procedure and one was associated with a recurrent PE.
Two events of vascular injury were reported: a non-
occlusive thrombus of the left external iliac vein and
leg ulcers with edema. There were no reports of access
site complications, filter fracture, filter embolization,
significant filter migration, or IVC occlusion in this
study.
Filter retrieval was attempted in 58 patients (mean
indwell time to attempted retrieval: 185.6 days;
range 5-466 days). Based on venographic imaging at
retrieval, no IVC perforations were noted and 21 cases
of IVC penetration (i.e., transmural incorporation) were
noted; there were no patient-reported symptoms
Filter Indwell Time
Weeks
0
4
12
26
52
60
INSTRUCTIONS FOR USE
The product is intended for use by physicians
trained and experienced in diagnostic and
interventional endovascular techniques. Standard
techniques for placement of vascular access
sheaths, angiographic catheters and wire guides
should be employed. It is assumed that the
operator will use local anesthesia, sedation and
analgesia as required.
Preparation
1. Flush the introducer sheath and the introducer
dilator.
2. Advance the introducer dilator through the
middle of the Check-Flo valve on the introducer
sheath. Secure the introducer dilator to the
introducer sheath by twisting the dilator hub
clockwise until a click is felt. (Fig. 2)
Kaplan-Meier Estimated
Probability of Successfully Retrieving
the Celect Filter
100%
100%
100%
100%
90%
75%
Filter Placement
Illustrations
(e.g., pain). Among the 58 patients with imaging data
at placement and retrieval, five had observations of
significant tilt at placement and two had observations
of significant tilt at retrieval. Fifty-six (56) retrievals
(96.6%) were successful (mean indwell time for
successful retrievals: 179 days; range 5-466 days).
The two unsuccessful retrievals were attributed to
an inability to capture the filter hook due either to
excessive filter tilt (360 days) or to tissue growth
causing the hook to become embedded in the
endothelium (without tilt; 385 days), respectively.
There were no MAEs associated with the filter retrieval
procedure. A Kaplan-Meier product limit estimate (see
Figure below) indicates the estimated probability of
successful retrieval of the Cook Celect Filter based on
the study data; the probability of successful retrieval
remains at 100% at up to 50 weeks post-implant and
at 75% after 55 weeks post-implant.
3. Access the chosen jugular vein using the
Seldinger technique.
4. Perform diagnostic imaging to confirm a
single IVC, measure the IVC diameter, check for
thrombus, and establish the position of the renal
veins.
5. Place a supportive .035 inch wire guide in the IVC.
6. If necessary, dilate the puncture site with the
10 French pre-dilator.
7. Remove the pre-dilator and advance the coaxial
introducer system over the wire guide until the tip
of the introducer sheath lies approximately 5 cm
caudal to the lowest renal vein.
8. Remove the wire guide.
9. Perform diagnostic imaging to verify position of
the introducer sheath tip (or radiopaque marker)
approximately 5 cm caudal to the lowest renal
vein.
Standard
Error
0.00
0.00
0.00
0.00
0.09
0.16
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