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Sealing zone thrombus, calcium, or plaque covering > 50% (180°) of the vessel circumference
■
•
The Heli-FX EndoAnchor system is not recommended in patients with known sensitivity or allergy to contrast agents that are necessary for intraoperative and postoperative
follow-up imaging, or whose renal function may be compromised by the follow-up protocols required for the endovascular graft
•
Do not use in patients with a known sensitivity or allergy to the EndoAnchor device materials (MP35N-LT, which is an alloy of nickel, chromium, molybdenum, and cobalt)
4.3. Implant procedure
•
Systemic anticoagulation should be used during the implantation procedure based on hospital and physician protocol. If heparin is contraindicated, an alternative
anticoagulant should be considered.
•
Maintain guidewire position during insertion of the Heli-FX Guide with Obturator.
•
Always use fluoroscopy for guidance, delivery, and observation of any Heli-FX system components within the vasculature.
•
Do not continue advancing any portion of the Heli-FX system if resistance is felt during advancement of the guidewire, sheath, or catheter. Stop and assess the cause of
resistance. Vessel, endograft, or catheter damage may occur.
•
The use of the Heli-FX EndoAnchor system may require administration of intravascular contrast medium. Patients with pre-existing renal insufficiency may have an increased
risk of renal failure postoperatively. Care should be taken to limit the amount of contrast media used during the procedure.
•
Care should be taken during manipulation of catheters, wires, and sheaths within an aneurysm and within a previously placed endograft. Significant disturbances may
dislodge fragments of thrombus, which can cause distal embolization, or cause displacement of the endograft, which can lead to endoleaks.
•
Incorrect positioning of the Heli-FX Guide and Applier may lead to misdeployment of an EndoAnchor implant.
4.4. MRI safety and compatibility
•
The EndoAnchor implants 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 EndoAnchor implants.
•
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 EndoAnchor implants are being used, or by the EndoAnchor implants, whichever values are smaller.
•
Because the EndoAnchor implants 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 EndoAnchor implants 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 EndoAnchor implants are being
used.
5. Adverse events
Potential adverse events associated with use of the EndoAnchor Implant
Potential adverse events that are associated with the Heli-FX EndoAnchor system, include, but are not limited to:
•
Aneurysm rupture
•
Death
•
EndoAnchor implant 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 acute kidney injury)
•
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. Refer to the Instructions for Use provided with the endograft for additional
potential adverse events.
Adverse event reporting
Any complaints (including adverse events, unanticipated adverse device effects, and incidents) involving the Heli-FX EndoAnchor system should be reported to Medtronic Vascular
immediately.
6. How supplied
The Heli-FX EndoAnchor system components (Heli-FX Guide, Heli-FX Applier and Cassette with EndoAnchor implants) are supplied sterile. The Heli-FX Applier package includes
one EndoAnchor Cassette, containing 10 preloaded EndoAnchor implants.
Do not use after the Use-by date printed on the label.
Table 2 details the available components of the Heli-FX EndoAnchor system.
System
Heli-FX system (16 Fr outer diameter; 62 cm working length)
Heli-FX Thoracic system (18 Fr outer diameter; 90 cm working length)
All Heli-FX Systems
The Heli-FX devices are intended for single use only. Do not reuse or resterilize the devices.
•
Reprocessing or reuse of single-use devices may compromise the structural integrity of the device, essential material and design characteristics, and lead to device failure.
•
Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
•
This product was tested for electrical safety for the intended single use only. Any reuse may pose the risk of electrical shock, insufficient isolation, and temperatures elevated
above the temperatures intended for the components.
8
Instructions for Use
English
Table 2. Heli-FX system components
Heli-FX Applier with EndoAnchor Cassette (containing 10 EndoAnchor implants)
Heli-FX Guide (22 mm reach)
Heli-FX Guide (28 mm reach)
Heli-FX Applier with EndoAnchor Cassette (containing 10 EndoAnchor implants)
Heli-FX Guide (22 mm reach)
Heli-FX Guide (32 mm reach)
Heli-FX Guide (42 mm reach)
Ancillary EndoAnchor Cassette (containing 5 EndoAnchor implants)
Component
Model number
SA-85
SG-64
HG-16-62-28
HA-18-114
HG-18-90-22
HG-18-90-32
HG-18-90-42
EC-05
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