Sentry Bioconvertible IVC Filter Brief Summary

Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS

Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via percutaneous placement in the inferior vena cava in patients at transient risk of PE, in the following situations:

  • Pulmonary thromboembolism when anticoagulants are contraindicated.
  • Failure of anticoagulant therapy in thromboemboliic diseases.
  • Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced

CONTRAINDICATIONS

Sentry IVC Filter should not be implanted in:

  • Patients with an average IVC diameter greater than 28mm
  • Patients with an average IVC diameter less than 16mm
  • Patients with an Infrarenal IVC of <9cm in length
  • Patients with risk of septic embolism
  • Pregnant patients when fluoroscopy may endanger the fetus
  • Risks and benefits should be assessed carefully
  • Patients with uncontrolled sepsis
  • Patients with demonstrated hypersensitivity to one of the components of the Filer (Nitinol; nickel and titanium, Poly p-dioxanone)

WARNINGS

  • Do not place the Filter in patients scheduled for surgery within two weeks of implantation, if the surgery is likely to involve manipulation of the IVC
  • Patients with spinal or other anatomical irregularity may interfere with the successful delivery, deployment, geometry or stability of the Sentry IVC Filter
  • Do not deploy the Filter unless the IVC diameter has been accurately measured; the Filter is intended for use in IVC diameters between 16mm and 28mm. If the IFC diameter is greater than 28mm or less than 16mm in diameter do not deploy the Filter
  • Do not place the filter in patients with dual IVC
  • The Filter is designed to be implanted using right internal jugular or right/left femoral veins. Extreme care must exercised when attempting placement via a left femoral vein insertion-tortuous venous anatomy can cause sheath kinking and make filter insertion difficult or impossible
  • The Filter is a permanent implant. Sentry IVC Filter is not a retrievable filter. Attempting to retrieve the Filter will result in damage to the Filter or the IVC
  • Sentry IVC Filter is designed to protect patients at transient risk from PE. In the SENTRY clinical study 100% of Filters were filtering at the 1-month follow-up, 95.3% of Filters were filtering at the 2-month follow-up and at the 6-month follow-up 95.7% Filters had Bioconverted
  • Refer to the Clinical Summary for clinical experience with Sentry IVC Filter
  • Procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the Filter
  • Filter fractures are a known complication of IVC filters. There have been reports of serious pulmonary and cardiac complications with IVC filters requiring the retrieval of the fragment utilizing endovascular and or surgical techniques. Refer to the Clinical Summary for clinical experience with Sentry IVC Filter
  • Movement, migration and tilt are known complications of IVC filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal filter migration. Migration may be caused by placement in IVCs with diameters exceeding the dimensions specified in the Filter IFU. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. Refer to Clinical Summary for clinical experience with Sentry IVC Filter.

PRECAUTIONS

  • The Safety and effectiveness of this device has not been established for pediatric patients
  • Venacavography must always be performed to select a proper implant site. Radiographs, without contrast, which do not clearly show the wall of the IVC, may be misleading
  • Patients should be returned to anti-thrombotic therapy as soon as it is deemed safe
  • The safety and effectiveness of this device has not been established for pregnancy, nor in suprarenal placement position. Following Filter placement, no central venous catheterization should be attempted without fluoroscopic guidance to ensure the location of the deployed Filter is known thereby reducing potential for entrapment of other devices in the Filter and subsequent sequelae

POTENTIAL COMPLICATIONS

Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure.

Possible complications associated with IVC filter implantation include, but are not limited to, the following:

  • Access site complications (hemorrhage, thrombus, aneurysm, infection, intervention)
  • Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter or originated from superior or collateral vessels
  • Arteriovenous fistula
  • Blood loss
  • Death
  • Edema
  • Embolism/Air embolism
  • Hematoma or nerve injury at the puncture site
  • Hemorrhage with or without transfusion
  • Extravasation of contrast material at time of vena cavogram
  • Infections (local or systemic)
  • IVC filter complications
  • Caval thrombosis, stenosis or occlusion

 

PI-719210-AA

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