IMPORTANT SAFETY INFORMATION
Prior to using the Tack Endovascular System, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
The Tack Endovascular System (6F, 3.5-6.0mm and 4.0-8.0mm) is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm and 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
The Tack Endovascular System (4F, 1.5-4.5mm) is intended for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
CONTRAINDICATIONS FOR USE
The Tack Endovascular System is contraindicated for the following:
- Patients with residual stenosis in the treated segment equal to or greater than 30% after PTA.
- Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device.
- Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol).
- Patients unable to receive standard medication used for interventional procedures such as anticoagulants, contrast agents and antiplatelet therapy.
Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device:
- Access failure or abrupt closure
- Allergic / anaphylactoid reaction to anticoagulant and/or antithrombotic therapy or contrast medium
- Allergic reaction to Nitinol
- Amputation of lower extremity
- Angina / coronary ischemia / myocardial infarction
- Arterial occlusion / (re) stenosis / dissection / thrombus
- Arterial spasm
- Arteriovenous fistula
- Blue toe syndrome
- Claudication or rest pain, worsened
- Disseminated intravascular coagulation
- Emergent repeat hospital intervention
- Gastrointestinal bleed from anticoagulation / antiplatelet medication
- Hematoma / hemorrhage
- Hypotension / hypertension
- Inadvertent venipuncture
- Infection / abscess at insertion site / Cellulitis
- Multi-organ failure
- Renal insufficiency or failure
- Respiratory distress or failure
- Reperfusion pain
- Septicemia / bacteremia (sepsis)
- Swelling / Edema, peripheral
- Tack implant embolization
- Tack implant migration (device moves over time)
- Tack implant occlusion / restenosis
- Tissue necrosis
- Trauma to adjacent structures
- Stroke / TIA (hemorrhagic / embolic)
- Vascular complications which may require surgical repair