OPTEASE® Retrievable Vena Cava Filter

Indications

The OPTEASE® Filter is indicated for use in the preventio of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated.
• Failure of anticoagulant therapy for thromboembolic disease.
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
• 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.
• Patients with uncontrolled infectious disease.
• Patients with an IVC diameter larger than 30 mm.
• Patients contraindicated for procedures under fluoroscopy.
• Patients with demonstrated hypersensitivity to one of the components of the OPTEASE® Filter. There are no known contraindications for use of the Angiographic Vessel Dilator.

Warnings

For Filter Placement:

• Retrieval of the OPTEASE® Filter is possible only from femoral vein approach. Do not implant the filter with the intention to retrieve using the jugular access.
• All components in the OPTEASE® Introduction Kit with
• Angiographic Vessel Dilator are for single use only. Do not resterilize or reuse. Structural integrity and/ or function may be impaired through cleaning, resterilization, or reuse and may cause adverse patient reactions. Accordingly, Cordis will not be responsible for any direct or consequential damages or expenses resulting from reuse of any of the components in the OPTEASE® Introduction Kit.
• When injecting contrast medium through the Angiographic Vessel Dilator, do not exceed maximum pressure rating of 800 psi. Ensure that a high-pressure connection line is used.
• After filter implantation, any catheterization procedure requiring passage of a device through the filter may be impeded.
• The OPTEASE® Filter is supplied constrained in a plastic storage tube indicating the appropriate orientation for jugular approach. Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could result in incorrect orientation for the selected access site. Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could affect its shape, and function.
• Implant of the OPTEASE® Filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures, ineffective pulmonary embolism prevention or death.
• Filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. However, reports of adverse clinical sequelae from filter fractures are rare.
• The OPTEASE® Filter should only be used by physicians who are trained in diagnostic and percutaneous interventional techniques, for instance placement of vena cava filters.
• Persons with allergic reactions to nickel titanium (Nitinol) may suffer an allergic response to this implant.
• In patients with acute pulmonary embolism in which the OPTEASE® Filter is inserted as an alternative to anticoagulation therapy, a conventional course of anticoagulation therapy should be started if the risk of bleeding resolves.
• Where practicable, a retrievable filter should be removed if a conventional course of anticoagulation therapy can be started, or if the underlying reason for indication is resolved. For Optional Filter Retrieval
• Excessive force should not be used to retrieve the filter.
• Retrieval of the Filter should not be attempted if thrombus is present in the filter and/or caudal to the filter.
• Available data from retrievals in a 21 patient study and a 40 patient retrospective chart review suggest that the OPTEASER Filter can be safely retrieved (mean of 11.1 days, range 5–14 days and mean of 16.4 days, range 3–48 days, respectively). Please refer to the Clinical Experience section of this IFU. The OPTEASE® Filter is considered a permanent filter if it is not retrieved within a clinically suitable time period.
• Where practicable, a retrievable filter should be removed if a conventional course of anticoagulation therapy can be started, or if the underlying reason for indication is resolved.
• The OPTEASE® Filter must be implanted with the fixation barbs to the cranial end and retrieval hook to the caudal end of the filter.
• Retrieval of the OPTEASE® Filter is possible only from femoral vein approach. Before attempting retrieval of the OPTEASE® Filter from the femoral access site, verify that the filter retrieval hook is at the caudal end of the filter, i.e. caudal orientation in the IVC. The retrieval hook at the caudal end of the filter is the location for endovascular snare engagement.
• Retrieval of the OPTEASE® Filter with a filter fracture present may result in complications.
• Retrieval of the OPTEASE® Filter should only be performed by physicians who are trained in percutaneous interventional techniques.
• Never redeploy a retrieved filter.
• Please refer to Section IX labeled Optional Procedure for Filter Retrieval.

Precautions

• Store in a cool, dark, dry place.
• Do not use if package is open or damaged.
• Use prior to “Use By” date.
• Do not resterilize.
• This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use.
• Reuse of this product, including after reprocessing and/ or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/ use information all of which present a potential risk to patient safety.
• Do not expose to organic solvents.
• The OPTEASE® Filter has been tested and qualified with the accompanying accessories. The use of any other accessory could result in complications and/or an unsuccessful procedure.
• Advancement, manipulation and withdrawal of the OPTEASE® Filter or its accessories should always be performed under fluoroscopic control.
• If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. It is the responsibility of the physician to use his/her judgment, based on patient safety and clinical experience, regarding the acceptability level of any resistance and/or whether to continue or abort the retrieval attempt.
• The safety and effectiveness of the OPTEASE® Filter has not been established in patients who are known to be pregnant or who are lactating.

Jugular / Antecubital Approach
Indications

The OPTEASE® Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated.
• Failure of anticoagulant therapy for thromboembolic disease.
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. The OPTEASE® Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

Contraindications

Vena cava filters should not be implanted in:

• Patients with risk of septic embolism.
• Patients with uncontrolled infectious disease.
• Patients with an IVC diameter larger than 30 mm.
• Patients contraindicated for procedures under fluoroscopy.
• Patients with demonstrated hypersensitivity to one of the components of the OPTEASE® Filter. There are no known contraindications for use of the Angiographic Vessel Dilator.

Warnings

For Filter Placement:

• Retrieval of the OPTEASE® Filter is possible only from femoral vein approach. Do not implant the filter with the intention to retrieve using the jugular access.
• All components in the OPTEASE® Introduction Kit with Angiographic Vessel Dilator are for single use only. Do not resterilize or reuse. Structural integrity and/or function may be impaired through cleaning, resterilization, or reuse and may cause adverse patient reactions. Accordingly, Cordis will not be responsible for any direct or consequential damages or expenses resulting from reuse of any of the components in the OPTEASE® Introduction Kit.
• When injecting contrast medium through the Angiographic Vessel Dilator, do not exceed maximum pressure rating of 800 psi. Ensure that a high-pressure connection line is used.
• After filter implantation, any catheterization procedure requiring passage of a device through the filter may be impeded.
• The OPTEASE® Filter is supplied constrained in a plastic storage tube indicating the appropriate orientation for jugular/antecubital approaches. Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could result in incorrect orientation for the selected access site. Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could affect its shape, and function.
• Implant of the OPTEASE® Filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures, ineffective pulmonary embolism prevention or death.
• Filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. However, reports of adverse clinical sequelae from filter fractures are rare.
• The OPTEASE® Filter should only be used by physicians who are trained in diagnostic and percutaneous interventional techniques, for instance placement of vena cava filters.
• Persons with allergic reactions to nickel titanium (Nitinol) may suffer an allergic response to this implant.
• In patients with acute pulmonary embolism in which the OPTEASE® Filter is inserted as an alternative to anticoagulation therapy, a conventional course of anticoagulation therapy should be started if the risk of bleeding resolves.
• Where practicable, a retrievable filter should be removed if a conventional course of anticoagulation therapy can be started, or if the underlying reason for indication is resolved.

Precautions

• Store in a cool, dark, dry place.
• Do not use if package is open or damaged.
• Use prior to “Use By” date.
• Do not resterilize.
• This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use.
• Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/ use information all of which present a potential risk to patient safety.
• Do not expose to organic solvents.
• The OPTEASE® Filter has been tested and qualified with the accompanying accessories. The use of any other accessory could result in complications and/or an unsuccessful procedure. Advancement, manipulation and withdrawal of the OPTEASE® Filter or its accessories should always
• If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. It is the responsibility of the physician to use his/her judgment, based on patient safety and clinical experience, regarding the acceptability level of any resistance and/or whether to continue or abort the retrieval attempt.
• The safety and effectiveness of the OPTEASE® Filter has not been established in patients who are known to be pregnant or who are lactating

Femoral Approach
Indications

The OPTEASE® Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated.
• Failure of anticoagulant therapy for thromboembolic disease.
• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
• 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.
• Patients with uncontrolled infectious disease.
• Patients with an IVC diameter larger than 30 mm.
• Patients contraindicated for procedures under fluoroscopy.
• Patients with demonstrated hypersensitivity to one of the components of the OPTEASE® Filter. There are no known contraindications for use of the Angiographic Vessel Dilator.

Warnings

For Filter Placement:

• Retrieval of the OPTEASE® Filter is possible only from femoral vein approach. Do not implant the filter with the intention to retrieve using the jugular access.
• All components in the OPTEASE® Introduction Kit with Angiographic Vessel Dilator are for single use only. Do not resterilize or reuse. Structural integrity and/or function may be impaired through cleaning, resterilization, or reuse and may cause adverse patient reactions. Accordingly, Cordis will not be responsible for any direct or consequential damages or expenses resulting from reuse of any of the components in the OPTEASE® Introduction Kit.
• When injecting contrast medium through the Angiographic Vessel Dilator, do not exceed maximum pressure rating of 800 psi. Ensure that a high-pressure connection line is used. After filter implantation, any catheterization procedure requiring passage of a device through the filter may be impeded.
• The OPTEASE® Filter is supplied constrained in a plastic storage tube indicating the appropriate orientation for femoral approach.
• Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could result in incorrect orientation for the selected access site. Never reload a fully ejected or partially ejected OPTEASE® Filter into the storage tube as this could affect its shape, and function.
• Implant of the OPTEASE® Filter with the hook oriented in the cranial direction can result in life threatening or serious injury including, but not limited to dissection, vessel perforation, migration of the filter with secondary damage to cardiac structures, ineffective pulmonary embolism prevention or death.
• Filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. However, reports of adverse clinical sequelae from filter fractures are rare.
• The OPTEASE® Filter should only be used by physicians who are trained in diagnostic and percutaneous interventional techniques, for instance placement of vena cava filters.
• Persons with allergic reactions to nickel titanium (Nitinol) may suffer an allergic response to this implant.
• In patients with acute pulmonary embolism in which the OPTEASE® Filter is inserted as an alternative to anticoagulation therapy, a conventional course of anticoagulation therapy should be started if the risk of bleeding resolves. Where practicable, a retrievable filter should be removed if a conventional course of anticoagulation therapy can be started, or if the underlying reason for indication is resolved.

Precautions

• Store in a cool, dark, dry place.
• Do not use if package is open or damaged.
• Use prior to “Use By” date. This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use.
• Reuse of this product, including after reprocessing and/ or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/ use information all of which present a potential risk to patient safety.
• Do not expose to organic solvents.
• The OPTEASE® Filter has been tested and qualified with the accompanying accessories. The use of any other accessory could result in complications and/or an unsuccessful procedure.
• Advancement, manipulation and withdrawal of the OPTEASE® Filter or its accessories should always be performed under fluoroscopic control.
• If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding. It is the responsibility of the physician to use his/her judgment, based on patient safety and clinical experience, regarding the acceptability level of any resistance and/or whether to continue or abort the retrieval attempt.
• The safety and effectiveness of the OPTEASE® Filter has not been established in patients who are known to be pregnant or who are lactating.

• Cordis Endovascular Catalog