B. Braun VenaTech RETRIEVABLE 04435150, Instructions For Use Manual

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Implantation period
This retrievable filter is designed to provide effective protection against pulmonary embolism .
If clinical needs require the retrieval of the filter, adequate time should be given for the treatment of
any captured clot prior to removal. Up to two weeks additional implantation period may be required for
such treatment.
The VenaTech® RETRIEVABLE, Vena Cava Filter System can be safely retrieved up to
12 weeks after
implantation. After this period of time, retrieval may be impossible and the permanent indication
must be considered.
Access site
This VenaTech® RETRIEVABLE, Vena Cava Filter System is designed to be implanted via the right femoral
vein, in the Inferior Vena Cava (IVC) at the infrarenal position below the renal veins.
Extreme care must be exercised when attempting placement in the IVC via a left femoral insertion.
Warning:
• Avoid a venous access site previously used for central venous catheter placement. Implantation of a Vena
Cava Filter using an existing access site can result in incomplete filter deployment. This could in turn result
in filter migration and/or inadequate protection against pulmonary embolism.
• Do not deploy the filter unless the Inferior Vena Cava diameter has been properly determined.
• Never advance the guidewire or introducer catheter or deploy the filter without fluoroscopic guidance.
• Migration of the filter has been reported following direct manipulation of the IVC or its compression
during abdominal surgery and, especially, retroperitoneal surgery.
• Migration of the filter could occur during specific activities, no strenuous physical exercises should be
undertaken (e.g. Valsava maneuver) which increase the intra-abdominal pressure.
• After use, the VenaTech® RETRIEVABLE, Vena Cava Filter System and accessories may be a potential
biohazard. Handle and dispose of in accordance with the current medical practice and applicable laws
and/or regulations.
Note: Extreme care must be exercised during approaches through tortuous or twisted anatomies which can
cause sheath kinking and make filter insertion difficult or impossible. Under extreme conditions, attempting
to force the filter through a kinked sheath could result in sheath perforation. Always stop pushing on the
filter if significant resistance is encountered.
Filter diameter
The diameter of the Vena Cava, as evaluated during cavography, must be 14mm and 28 mm from
an AP projection when corrected for magnification. In cases in which measurement is accomplished using
Computed Tomography (CT), the section with the largest diameter should be used.
Important: Do not attempt to increase the diameter of the filter.
Filter placement in case of pregnancy
In pregnant patients where the fetus may be endangered by fluoroscopy, risks and benefits for the mother
and the fetus should be carefully assessed.
The safety and effectiveness of this device has not been established during pregnancy, nor in a suprarenal
position.