Adverse Events; Directions For Use - aptus Heli-FX Instrucciones De Uso

MRI Safety and Compatibility
• The EndoAnchors have been determined to be MR Conditional at 3T or less when the scanner
is in Normal Operating Mode with whole body averaged SAR of 2 W/kg, or in First Level
Controlled Mode with a maximum whole body averaged SAR of 4 W/kg.
• Nonclinical testing using a Siemens 3T Trio whole body MR system with a body transmit/body
receive coil and a spin echo sequence (TR = 500 ms and TE = 35 ms) produced an image artifact
extending less than 10 mm from the EndoAnchors.
• The allowed values for the static magnetic field, the spatial gradient, and the whole body
averaged specific absorption rate are given by the maximum allowed values for the endograft
system with which the EndoAnchors are being used, or by the EndoAnchors, whichever values
are smaller.
Because the EndoAnchors are small in dimension and have not shown significant force, torque,
and heating effects, the values limiting the MRI exposure for a patient with a stent graft system
including the EndoAnchors are typically given by the endograft system.
Please refer to documentation provided by the endograft system manufacturer for MR safety
status of the endograft system with which the EndoAnchors are being used.

5.0 ADVERSE EVENTS

Potential Adverse Events Associated with use of the EndoAnchor
Potential adverse events that are associated with the Heli-FX EndoAnchor System, include, but are
not limited to:
• Aneurysm rupture
• Death
• EndoAnchor embolization
• Endoleaks (Type III)
• Enteric fistula
• Failure to correct/prevent Type I endoleak
• Failure to prevent endograft migration
• Infection
• Renal complications (renal artery occlusion/dissection or contrast-induced AKI)
• Stroke
• Surgical conversion to open repair
• Vascular access complications, including infection, pain, hematoma, pseudoaneurysm,
arteriovenous fistula
• Vessel damage, including dissection, perforation, and spasm
Additional potential adverse events may be associated with endovascular aneurysm repair in general.
Please refer to the endograft IFU for additional potential adverse events.
Heli-FX® EndoAnchor® System EN
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