Safety Information – AFX

AFX Safety Information

← Back

Indications for Use

The AFX® Endovascular AAA Delivery System is indicated for endovascular treatment in patients with AAA. The devices are indicated for patients with suitable aneurysm morphology for endovascular repair, including:

  • Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥ 6.5 mm)
  • Non-aneurysmal aortic neck between the renal arteries and the aneurysm:
    • with a length of ≥ 15 mm
    • with a diameter of ≥ 18 mm and ≤ 32 mm
    • with a neck angle of ≤ 60° to the body of the aneurysm.
  • Aortic length ≥ 1.0 cm longer than the body portion of the chosen bifurcated model.
  • Common iliac artery distal fixation site:
    • with a distal fixation length of ≥ 15 mm
    • with ability to preserve at least one hypogastric artery
    • with a diameter of ≥ 10 mm and ≤ 23 mm
    • with an iliac angle of ≤ 90° to the aortic bifurcation.
  • Extension stent grafts must have the ability to overlap the bifurcated stent graft by at least by at least 30 to 40mm proximally and at least 15 to 20 mm distally.

Contraindications

  • Patients who have a condition that threatens to infect the stent graft
  • Patients with sensitivities or allergies to the device materials
← Back

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the AFX Endovascular AAA Stent Graft is MR Conditional.

A patient with this implant can be scanned safely under the following conditions:

  • Static magnetic field of 1.5 Tesla and 3.0 Tesla
  • Spatial gradient field of 750 Gauss/cm or less
  • Normal operating mode or a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 1.5 Tesla or 3.0 Tesla MR scanner.

MRI-Related Heating

In non-clinical testing, the Endologix Stent Graft produced the following temperature rises during MRI performed for 15 minutes in 1.5 Tesla (1.5 Tesla/64MHz, Magnetom, Software Numaris/4 version Syngo MR 2002B DHHS, Siemens Medical Solutions, Malvern, PA) and 3.0 Tesla (3.0 Tesla/128MHz, Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) MR Systems as follows:

Highest Temperature Change (°C) MRI Condition
3.6 1.5 Tesla/64MHz
2.3 3.0 Tesla/128MHz

Therefore, the MRI-related heating experiments for the Endologix Stent Graft at 1.5 Tesla and 3.0 Tesla using a transmit/receive RF body coil at MR system reported whole body average specific absorption rates (SARs) of 2.9 W/kg (i.e., associated with a calorimetry value of 2.1 W/kg) and 3.0 W/kg (i.e., associated with a calorimetry value of 2.8 W/kg), respectively, indicated that the greatest amount of heating that occurred in association with these specific conditions was less than or equal to 3.6°C.

Image Artifact (1.5 and 3.0 Tesla MR Systems).

The image artifact extends approximately 10 – 20mm from the device, both inside and outside the device lumen when scanned in non-clinical testing using T1-weighted spin echo and gradient echo pulse sequences in a 3.0 Tesla MR system.

The artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal loss) that were moderate in size relative to the size and shape of these implants. The gradient echo pulse sequence produced larger artifacts than the T1 -weighted, spin echo pulse sequence for the Endologix Stent Graft. MR imaging quality may be compromised if the area of interest is in the same area or relatively close to the position of the stent graft. Therefore, it may be necessary to optimize MR imaging parameters to compensate for the presence of this implant.

← Back

Warnings and Precautions

The AFX Endovascular AAA System is not recommended in patients who cannot tolerate contrast agents necessary for intra-operative and post-operative follow-up imaging.

Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60° between the infrarenal neck to axis to the aneurysm body); irregular and/or short proximal aortic neck (<15 mm); and thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Irregular calcification and/or plaque may compromise graft integrity or the fixation and sealing of the implantation sites. Necks exhibiting these key anatomic elements may be more conducive to graft migration.

Access vessel diameter and morphology (minimal tortuosity, occlusive disease, and/or calcification) should be compatible with vascular access techniques and delivery systems of a 19Fr profile. The AFX Endovascular AAA System is delivered through the AFX Introducer System, provided separately. Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization. Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.

Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to Type II endoleak. Patients with uncorrectable coagulopathy may also have an increased risk of Type II endoleak or bleeding complications.

The long-term performance of endovascular grafts has not yet been established. All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions For Use under, Imaging Guidelines and Post-Operative Follow-up.

After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft. At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (stent fracture, separation between bifurcated device and proximal cuffs or limb extensions, if applicable), and 2) contrast and non-contrast CT to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease. If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.

Additional endovascular intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak. An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture.

Patients experiencing reduced blood flow through the graft limb and/or endoleaks may be required to undergo secondary interventions or surgical procedures.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

← Back

Adverse Events

Adverse events that may occur and/or require intervention the AFX® Endovascular AAA System, include for but are not limited to:

Amputation, anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement, aneurysm rupture and death, aortic damage, including perforation, dissection, bleeding, rupture and death, arterial or venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, bleeding, hematoma or coagulopathy, bowel complications (e.g., ileus, transient ischemia, infarction, necrosis), cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension), claudication (e.g., buttock, lower limb), death, edema, embolization (micro and macro) with transient or permanent ischemia or infarction, endoleak. Stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture and perigraft flow, fever and localized inflammation, genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection), hepatic failure, impotence, Infection of the aneurysm, device access site, including abscess formation, transient fever and pain, lymphatic complications and subsequent attendant problems (e.g., lymph fistula), neurologic local or systemic complications and subsequent attendant problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis), occlusion of device or native vessel, pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, respiratory failure, prolonged intubation), renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure), surgical conversion to open repair, vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, vessel damage, wound complications and subsequent attendant problems (e.g., dehiscence, infection), vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death).

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

C01408