Valiant Navion™
Thoracic Stent Graft System—Instructions for Use
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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1
Valiant Navion™
Thoracic Stent Graft System—Instructions for Use
Table of contents
1. Device description ........................................................................................................................................................... 2
2. Indications for use ........................................................................................................................................................... 4
3. Contraindications ............................................................................................................................................................ 5
4. Warnings and precautions .............................................................................................................................................. 5
5. Adverse events ................................................................................................................................................................ 8
6. Patient selection, treatment, and device selection ...................................................................................................... 9
7. Patient counseling information .................................................................................................................................... 13
8. How supplied ................................................................................................................................................................. 13
9. Summary of Clinical Studies ........................................................................................................................................ 14
10. Directions for use .......................................................................................................................................................... 39
11. Troubleshooting techniques ......................................................................................................................................... 47
12. Follow-up imaging recommendations including MRI safety information ................................................................ 50
13. Additional surveillance and treatment ......................................................................................................................... 52
14. Device Registration ....................................................................................................................................................... 52
15. Disclaimer of warranty .................................................................................................................................................. 53
1. Device description
The Valiant Navion™ thoracic stent graft system is designed for the endovascular repair of lesions in the descending thoracic
aorta (DTA). When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within the
patient’s vasculature by excluding the lesion from blood flow and pressure.
The stent graft system is composed of 2 main components: the implantable Valiant Navion thoracic stent graft and the
disposable delivery system. The stent graft is preloaded into the delivery system. The loaded delivery system is inserted
endoluminally via the femoral or iliac artery and tracked through the patient’s vasculature to deliver the stent graft to the target
site. Upon deployment, the stent graft self-expands to conform to the shape and size of the seal zones above and below the
lesion.
The Valiant Navion thoracic stent graft system does not contain natural rubber latex; however, during the manufacturing
process, it may have had incidental contact with latex-containing products.
1.1. Stent graft
A single, primary Valiant Navion thoracic stent graft may be used by itself if its length is sufficient to provide the desired
coverage. Alternatively, it may be used in combination with additional Valiant Navion thoracic stent graft configurations that
increase the graft length distally or proximally to the primary section.
All stent grafts are composed of a self-expanding stent scaffold made from nitinol wire sewn to a fabric graft with nonresorbable
sutures. The metal scaffolding is composed of a series of serpentine stents stacked in a tubular configuration. Radiopaque
(RO) markers are sewn onto each component of the stent graft to aid in visualization and to facilitate accurate placement. The
nitinol stents are also visible under fluoroscopy. Refer to Table 1 (Stent graft materials) for a summary of the stent graft
materials.
The appropriate device sizing is incorporated into the sizing guidelines. Refer to Section 6.3 (Recommended device sizing)
and Section 6.4 (Device sizing recommendations) for detailed sizing information for all stent graft components.
Table 1. Stent graft materials
Component Material
Stents Nitinol (nickel-titanium) alloy
RO markers Platinum-iridium alloy
Graft fabric Polyester (PET)
Suture Polyester (PET) and ultra-high-molecular-weight polyethylene (UHMWPE)
2 Instructions for Use English
1.1.1. Stent graft configuration options
11
12
7
8
5
6
432
1
10
9
12
8
10
Figure 1. Stent graft configuration components
1. FreeFlo Straight
2. FreeFlo Tapered
3. CoveredSeal Straight
4. CoveredSeal Tapered
5. Proximal end
6. Distal end
7. FreeFlo stent
8. Internal stent
9. Support stent
10. RO marker
11. Covered length
12. Total length
Note: Figure 1 and all other product graphics appearing in this manual are not drawn to scale. They are for graphical
representation only, and the stent graft and delivery system components may appear differently under fluoroscopy.
Valiant Navion thoracic stent grafts are available in 4 configurations: FreeFlo Straight, FreeFlo Tapered, CoveredSeal Straight,
and CoveredSeal Tapered. Each stent graft configuration can be used either as a proximal or distal component; the proximal
end of a FreeFlo stent graft should never be placed inside the fabric-covered section of another graft. Stent grafts are available
in 18 Fr, 20 Fr, and 22 Fr delivery systems. Refer to Table 2 through Table 5 for stent grafts sizes in corresponding delivery
system sizes. Additional information on stent graft sizes is provided in Section 6.3 (Recommended device sizing)
and Section 6.4 (Device sizing recommendations).
FreeFlo Straight configuration
This configuration includes a FreeFlo proximal end and a CoveredSeal distal end. At the proximal end, a 6-peak (18 Fr or
20 Fr) or 7-peak (22 Fr) bare stent extends past the covered portion of the stent graft to provide additional fixation while
maintaining transvessel flow. The diameters of the proximal end and distal end of the FreeFlo Straight configuration are
constant throughout the covered length of the device.
The FreeFlo Straight configuration stent grafts are available in diameters ranging from 20 mm to 46 mm and covered lengths of
approximately 60 mm, 100 mm, 175 mm, and 225 mm.
Caution: The proximal end of a FreeFlo stent graft should never be placed inside the fabric-covered section of another graft as
doing so may result in abrasion of the fabric by the bare stent, resulting in graft material holes or broken sutures.
FreeFlo Tapered configuration
This configuration includes a FreeFlo proximal end and a CoveredSeal distal end. At the proximal end, a 6-peak (18 Fr or
20 Fr) or 7-peak (22 Fr) bare stent extends past the covered stent graft to provide additional fixation while maintaining
transvessel flow. The diameter of the proximal end of the FreeFlo Tapered configuration is larger than the diameter of the distal
end.
The FreeFlo Tapered configurations are available in proximal diameters ranging from 25 mm to 46 mm and distal diameters
ranging from 20 mm to 40 mm. The covered length is approximately 175 mm with a stent graft taper of 5 mm for the smallest
diameter configuration and 6 mm for the remaining sizes.
Caution: The proximal end of a FreeFlo stent graft should never be placed inside the fabric-covered section of another graft as
doing so may result in abrasion of the fabric by the bare stent, resulting in graft material holes or broken sutures.
Instructions for Use English 3
CoveredSeal Straight configuration
1
1213
11
14
2
3
45
679
8
10
This configuration includes CoveredSeal proximal and distal ends. At the proximal end, a 6-peak (18 Fr or 20 Fr) or 7-peak
(22 Fr) internal stent with a 12-peak (18 Fr or 20 Fr) or 14-peak (22 Fr) W-stent are covered to provide additional fixation while
maintaining transvessel flow. The diameters of the proximal end and distal end of the CoveredSeal Straight configuration are
constant throughout the covered length of the device.
The CoveredSeal Straight configuration stent grafts are available in diameters ranging from 20 mm to 46 mm and covered
lengths of approximately 60 mm, 100 mm, 175 mm, and 225 mm.
CoveredSeal Tapered configuration
This configuration includes CoveredSeal proximal and distal ends. At the proximal end, a 6-peak (18 Fr or 20 Fr) or 7-peak
(22 Fr) internal stent with a 12-peak (18 Fr or 20 Fr) or 14-peak (22 Fr) W-stent are covered to provide additional fixation while
maintaining transvessel flow. The diameter of the proximal end of the CoveredSeal Tapered configuration is larger than the
diameter of the distal end.
The CoveredSeal Tapered configurations are available in proximal diameters ranging from 25 mm to 46 mm and distal
diameters ranging from 20 mm to 40 mm. The covered length is approximately 175 mm and 200 mm with a stent graft taper of
5 mm for the smallest diameter configuration and 6 mm for the remaining sizes.
1.2. Delivery system
Figure 2. Delivery system
1. Luer connector
2. Screw gear
3. Slider handle
4. Trigger
5. Front grip
6. Graft cover
7. Stent stop
8. Tip capture mechanism
9. RO marker band
10. Tapered tip
11. Back-end lock
12. Tip capture release handle
13. Clamping ring
14. Flush port
The Valiant Navion delivery system consists of a single-use, disposable catheter with an integrated handle, intended to provide
controlled deployment. It is available in an outer diameter of 18, 20, and 22 Fr and a working length of 93 cm. The catheter
assembly is flexible and exclusively compatible with a 0.035 in (0.89 mm) guidewire.
A flexible tapered tip is attached to the end of the inner member and provides a smooth transition from the guidewire to the
outer graft cover. The external surfaces of the tapered tip and graft cover are coated with a lubricious hydrophilic coating. Once
activated with a sterile gauze saturated in saline, this coating facilitates vessel access and tracking through the anatomy. A
distal RO marker indicates the graft cover edge under fluoroscopy. The flush port includes a one-way valve that prevents
backflow of flush fluid and maintains hemostasis during the procedure, while allowing the delivery system to be flushed during
device preparation. The stent graft is deployed by rotating or retracting the integrated slider handle. The tip capture release
handle at the rear of the delivery system is unlocked and retracted to release the proximal end of the stent graft.
Note: The Reliant™ stent graft balloon catheter (packaged separately) can be used to remove wrinkles and folds from the graft
material and to assist in implanting the stent graft by modeling the covered stents.
2. Indications for use
The Valiant Navion thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic
aorta (DTA) in patients having the appropriate anatomy including:
4 Instructions for Use English
■
iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or
accessories;
■
nonaneurysmal aortic diameter in the range of:
■
16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers
■
16 mm to 44 mm for blunt traumatic aortic injuries
■
19 mm to 45 mm for dissections;
■
proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers
or nondissected length of aorta proximal to the primary entry tear for blunt traumatic aortic injuries and dissections) of:
■
≥ 20mm for FreeFlo configuration
■
≥ 25mm for CoveredSeal configuration; and
■
nonaneurysmal aortic distal neck length ≥ 20mm for FreeFlo and CoveredSeal configurations for fusiform and saccular
aneurysms/penetrating ulcers.
3. Contraindications
The Valiant Navion thoracic stent graft system is contraindicated in the following patient populations:
■
Patients who have a condition that threatens to infect the graft
■
Patients who are sensitive to or have allergies to the device materials (Table 1)
4. Warnings and precautions
4.1. Warnings and precautions - General Caution: Do not attempt to use the Valiant Navion thoracic stent graft system before completely reading and understanding the
information contained in the Instructions for Use. Failure to properly follow the instructions, warnings, and precautions may lead
to serious consequences or injury to the patient.
■
The Valiant Navion thoracic stent graft system should only be used by physicians and teams trained in vascular
interventional techniques, including training in the use of this device. Refer to Section 6.2.2 (Recommended skills and
training).
■
Always have a vascular surgery team available during implantation or re-intervention procedures in the event that
conversion to open surgical repair is necessary.
■
The long-term safety and effectiveness of the Valiant Navion thoracic stent graft system has not been established. All
patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and
performance of the implanted endovascular stent graft. Specific follow-up guidelines are described in Follow-up Imaging
Recommendations (Section 12). Of note, patients with specific clinical findings should receive enhanced follow-up.
Caution: Federal (USA) law restricts this device for sale by or on the order of a physician.
4.2. Warnings and precautions - patient selection, treatment, and follow-up
■
The Valiant Navion thoracic stent graft system is not recommended in patients who cannot undergo, or who will not be
compliant with, the necessary preoperative and postoperative imaging and implantation procedures described in Section 10
(Directions for use), Section 11 (Troubleshooting techniques), and Section 12 (Follow-up imaging recommendations).
■
The Valiant Navion thoracic stent graft system is not recommended in patients who cannot tolerate contrast agents
necessary for intra-operative and postoperative follow-up imaging. Refer to Section 12 (Follow-up imaging
recommendations).
■
The Valiant Navion thoracic stent graft system is not recommended in patients exceeding weight and/or size limits which
compromise or prevent the necessary imaging requirements.
■
Before the procedure, perform preoperative planning for access and placement. Refer to Section 6.3 (Recommended
device sizing). Key anatomic elements that may affect successful exclusion of the aneurysm include tortuosity, short landing
zones, and thrombus and/or calcium at the implantation sites. In the presence of anatomical limitations, a longer landing
zone may be required to obtain adequate sealing and fixation.
■
The use of this device requires administration of radiographic agents. Patients with preexisting renal insufficiency may have
an increased risk of renal failure postoperatively.
■
Inappropriate patient selection may contribute to poor device performance.
■
The Valiant thoracic stent graft systems have not been evaluated in the following patient situations and/or populations in
which:
■
The patient is pregnant.
■
The patient requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
■
The patient has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft
(pseudo-/false aneurysm).
■
The patient has a mycotic aneurysm.
Instructions for Use English 5
■
The patient has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic
aneurysm.
■
The patient has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending
thoracic aorta, and/or in the aortic arch.
■
The patient requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant.
■
The patient has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
■
Treatment with the Valiant Navion thoracic stent graft would require intentional revascularization of the brachio-cephalic
artery, the left common carotid artery, or the celiac trunk.
■
The patient has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after
the planned implantation of the Valiant Navion thoracic stent graft. This does not include planned procedures that are
needed for the safe and effective placement of the stent graft (that is, carotid/subclavian transposition,
carotid/subclavian bypass procedure).
■
The patient has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment
sites that could compromise fixation and seal of the implanted stent graft.
■
The patient has a connective tissue disease (for example, Marfan's syndrome, aortic medial degeneration).
■
The patient has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
■
The patient has had an MI within 3 months of the procedure.
■
The patient has had a CVA within 3 months of the procedure.
■
The patient has a known allergy to anesthetic drugs.
■
The patient has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not
amenable to pretreatment.
■
The patient has an active or systemic infection at the time of the index procedure.
■
The patient is less than 18 years old.
■
The patient has acute, uncomplicated Type B dissection.
■
The patient has chronic Type B dissection.
■
The patient has an aortic fistula.
■
The patient has aortitis or an inflammatory aneurysm.
■
All patients with endovascular repair must undergo periodic imaging to evaluate the stent graft and vessel. Significant
aneurysm enlargement (>5 mm), the appearance of a new endoleak, migration resulting in an inadequate seal zone, or
continued flow into the false lumen in the case of a dissection, should prompt further investigation and may indicate the
need for additional intervention or surgical conversion. An increase in aneurysm size and/or persistent endoleak may lead
to aneurysm rupture.
4.3. Warnings and precautions - implant procedure
■
Do not bend, kink, or otherwise alter the delivery system prior to implantation because it may cause deployment difficulties.
■
Do not advance the guidewire or delivery system if resistance is felt. The cause of resistance must be assessed in order to
avoid vessel or delivery catheter damage.
■
Stent graft wire fractures are more likely to occur in conditions with an excessively oversized endoprosthesis, flexion,
kinking, or bending during cardiac or respiratory cycles. Wire fractures may have clinical consequences, such as endoleak,
endoprosthesis migration, or adjacent tissue damage.
■
Oversize the aortic portion of the stent graft using the sizing guidelines in Section 6.3 (Recommended device sizing)
and Section 6.4 (Device sizing recommendations).
■
Strictly adhere to the Valiant Navion thoracic stent graft system sizing configurations and guidelines (Table 2
through Table 8) when selecting the device size. The appropriate device oversizing is incorporated into the sizing
guidelines. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear.
■
Oversizing of the stent graft to the vessel by more than 10% may be unsafe in the presence of dissecting tissue or
intramural hematoma.
■
An inadequate seal zone could increase the risk of endoleak or migration of the stent graft. Migration may also be caused
by deployment of the proximal stent into a thrombus filled or severely angled vessel. Refer to Section 6.1 (Patient
selection).
■
Manipulation of wires, balloons, catheters, and endografts in the thoracic aorta may lead to vascular trauma including aortic
dissection and embolization.
■
Wrinkling of graft material may promote thrombus formation. Inflate a conformable balloon within the deployed stent graft
lumen to reduce wrinkling of the graft material.
Note: Medtronic recommends the Reliant balloon for use with the Valiant Navion thoracic stent graft. Data is not available
for use of other balloons for remodeling the Valiant Navion thoracic stent graft.
6 Instructions for Use English
■
Use the Reliant device according to the instructions for use supplied with the Reliant stent graft balloon catheter. Do not
attempt to use the Reliant device before completely reading and understanding the information supplied with the Reliant
stent graft balloon catheter.
■
Do not use the Reliant stent graft balloon catheter in patients with history of thoracic dissection disease. Do not overinflate the Reliant stent graft balloon within or outside of the graft material.
■
If the Reliant balloon's proximal and distal radiopaque markers are not completely within the covered portion of a stent
graft when expanding the prosthesis, there is an increased risk of vessel injury and/or rupture, and possible patient
death.
■
It is not recommended to position the Valiant Navion thoracic stent graft higher in the vessel in the presence of excessive
calcification or thrombus, due to the increased risk of dislodging material during distal repositioning of the Valiant Navion
thoracic stent graft. Refer to Section 10.5 (Positioning the delivery system).
■
Do not advance the Valiant Navion thoracic stent graft system when the stent graft is partially deployed and is apposed to
the vessel wall.
■
The proximal end of the covered Valiant Navion thoracic stent graft should not be placed beyond the origin of the left
common carotid artery (Zone 0 or Zone 1). See Figure 3.
Figure 3. Covered stent graft placement zones
■
Ensure that the Valiant Navion thoracic stent grafts are placed in an adequate landing zone comprised of suitable tissue.
Suitable tissue is defined as tissue without evidence of circumferential thrombus, intramural hematoma, ulceration, and/or
aneurysmal involvement. Failure to do so may result in inadequate exclusion or vessel damage, including perforation. Refer
to Section 6.1 (Patient selection).
■
Landing the proximal end of the device in dissected tissue could increase the risk of damage to the septum and could lead
to new septal tears, aortic rupture, retrograde dissection, or other complications.
■
When treating dissections, ensure the distal end of the device is in a straight portion of the aorta in order to reduce risk of
septum damage.
■
When treating acute dissections with multiple devices, it is recommended to deploy the proximal device first. Inadvertent
pressurization of the false lumen may result in retrograde dissection.
■
Consider adjunctive procedures to restore blood flow to malperfused branch vessels.
■
Any endoleak left untreated during the implantation procedure should be carefully followed after implantation.
■
Coverage of the left subclavian artery without revascularization may increase the risk of stroke.
■
Avoid occluding arterial branches that do not have collateral or protected perfusion to end organs or body structures. If the
LSA is to be covered, check the blood flow of the vertebral or cerebral arteries and the retrograde flow of the LSA. If
occlusion of the left subclavian artery ostium is required to obtain adequate neck length for fixation and sealing,
transposition or bypass of the LSA should be considered.
Caution: Patients with a patent LIMA-LAD (left internal mammary artery-left anterior descending artery) bypass should not
be considered for coverage of the LSA unless additional bypasses are performed prior to the stent graft procedure.
■
The proximal end of a FreeFlo stent graft should never be placed inside the fabric-covered section of another graft as doing
so may result in abrasion of the fabric by the bare stent, resulting in graft material holes or broken sutures.
Instructions for Use English 7
4.4. Magnetic Resonance Imaging (MRI)
MRI may be used on the Valiant Navion thoracic stent graft only under specific conditions. Refer to Section 12.5 (MRI safety
information).
5. Adverse events
5.1. Potential adverse events
Adverse events or complications associated with the use of the Valiant Navion thoracic stent graft system that may occur or
require intervention include, but are not limited to:
■
Access failure
■
Access site complications (for example, spasm, trauma,
bleeding, rupture, dissection)
■
Adynamic Ileus
■
Allergic reaction (to contrast, antiplatelet therapy, stent
graft material)
■
Amputation
■
Anaphylaxis
■
Anesthetic complications
■
Aneurysm rupture
■
Angina
■
Aortic expansion (for example: aneurysm, false lumen)
■
Aortic valve damage
■
Aortic vessel rupture
■
Arrhythmia
■
Arterial stenosis
■
Atelectasis
■
Balloon rupture
■
Blindness
■
Bowel ischemia
■
Bowel necrosis
■
Bowel obstruction
■
Branch vessel occlusion
■
Breakage of the metal portion of the device
■
Buttock claudication
■
Cardiac tamponade
■
Catheter breakage
■
Cerebrovascular accident (CVA)/Stroke
■
Change in mental status
■
Coagulopathy
■
Congestive heart failure
■
Contrast toxicity
■
Conversion to surgical repair
■
Damage to the vessel
■
Death
■
Deployment difficulties/failures
■
Dissection, perforation, or rupture of the aortic vessel &
surrounding vasculature
■
Embolism
■
Endoleaks
■
Excessive or inappropriate radiation exposure
■
Extrusion/erosion
■
Failure to deliver the stent graft
■
Femoral neuropathy
■
Lymphocele
■
Myocardial infarction
■
Neck enlargement
■
Nerve injury
■
Neuropathy
■
Occlusion - Venous or Arterial
■
Pain/reaction at catheter insertion site
■
Paralysis
■
Paraparesis
■
Paraplegia
■
Paresthesia
■
Perfusion of the false lumen
■
Peripheral ischemia
■
Peripheral nerve injury
■
Pneumonia
■
Postimplant syndrome
■
Post-procedural bleeding
■
Procedural bleeding
■
Prosthesis dilatation
■
Prosthesis infection
■
Prosthesis rupture
■
Prosthesis thrombosis
■
Pseudoaneurysm
■
Pulmonary edema
■
Pulmonary embolism
■
Reaction to anesthesia
■
Renal failure
■
Renal insufficiency
■
Reoperation
■
Respiratory depression or failure
■
Retrograde type A dissection
■
Sepsis
■
Seroma
■
Sexual dysfunction
■
Shock
■
Spinal neurological deficit
■
Stenosis
■
Stent graft migration
■
Stent graft misplacement
■
Stent graft occlusion
■
Stent graft rupture (for example: holes, tears)
8 Instructions for Use English
■
Fistula (including aortobronchia, aortoenteric, aortoeso-
■
Stent graft twisting or kinking
phogeal, arteriovenous, and lymph)
■
Gastrointestinal bleeding/complications
■
Genitourinary complications
■
Hematoma
■
Hemorrhage/bleeding
■
Hypotension/hypertension
■
Infection or fever
■
Insertion or removal difficulty
■
Intercostal pain
■
Intramural hematoma
■
Leg edema/foot edema
■
Loss of patency
■
Transient ischemic attack (TIA)
■
Thrombosis
■
Tissue necrosis
■
Vascular ischemia
■
Vascular trauma
■
Wound dehiscence
■
Wound healing complications
■
Wound infection
5.2. Adverse Event Reporting
Any adverse event or clinical incident involving the Valiant Navion thoracic stent graft system should be immediately reported to
Medtronic Vascular. To report an incident in the US, call (800) 465-5533.
6. Patient selection, treatment, and device selection
6.1. Patient selection
Patient selection factors should include, but are not limited to:
■
Patient age and life expectancy
■
Comorbidities (for example, cardiac pulmonary or renal insufficiency before surgery, morbid obesity, and so forth)
■
Patient’s suitability for open surgical repair
■
Patient’s anatomical suitability for endovascular repair
■
The risk of lesion rupture compared to the risks of endovascular repair
■
Ability to tolerate general, regional, or local anesthesia
■
Iliac or femoral access vessel morphology, such as thrombus, calcium formation, or tortuosity, that is compatible with
vascular access techniques, devices, or accessories
■
For treatment of aneurysms and penetrating atherosclerotic ulcer (PAU): non-aneurysmal aortic diameter in the range of
16 mm to 42 mm
■
For treatment of blunt traumatic aortic injuries (BTAI): non-aneurysmal aortic diameter in the range of 16 mm to 44 mm
■
For treatment of dissections: healthy, non-diseased aortic diameter in the range of 19 mm to 45 mm
■
Proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers
or nondissected length of aorta proximal to the primary entry tear for blunt traumatic aortic injuries and dissections;) of:
■
≥ 20mm for FreeFlo configuration
■
≥ 25mm for CoveredSeal configuration; and
■
Nonaneurysmal aortic distal neck length ≥ 20mm for FreeFlo and CoveredSeal configurations for fusiform and saccular
aneurysms/penetrating ulcers.
6.2. Treatment
6.2.1. Individualization of Treatment
The warnings and precautions previously described in Section 4 should be carefully considered relative to each patient before
use of the Valiant Navion thoracic stent graft system. The risks and benefits should be carefully considered for each patient
before use of the Valiant Navion thoracic stent graft system.
Proper sizing of the device is the responsibility of the physician. Refer to Section 6.3 (Recommended device sizing).
Caution: Vessel damage such as dissection, perforation, or rupture may be caused by excessive oversizing of the stent graft in
relation to the diameter of the blood vessel. Oversizing of the stent graft to the vessel more than the recommended device
sizing as shown in Section 6.3 (Recommended Device Sizing), may be unsafe, especially in the presence of dissecting tissue
or intramural hematoma. Excessive or insufficient oversizing may also result in Type I endoleak. Consider vessel tortuosity
when selecting stent graft length. If preoperative case planning measurements are not certain, an inventory of system lengths
and diameters necessary to complete the procedure should be available to the physician. This approach allows for greater
intraoperative flexibility to achieve optimal procedural outcomes. Using the device outside the recommended anatomical sizing
may result in serious device-related adverse events. Physicians may consult with a Medtronic representative to determine
proper stent graft component dimensions based on the physician's assessment of the patient's anatomical measurements.
Instructions for Use English 9
However, the final treatment decision is at the discretion of the physician and patient. The benefits and risks previously
described should be carefully considered for each patient before using the Valiant Navion thoracic stent graft system.
6.2.2. Recommended Skills and Training
The recommended skill/knowledge requirements for physicians using the Valiant Navion thoracic stent graft system are outlined
below:
Patient Selection
■
Knowledge of the natural history of thoracic aortic lesions, including but not limited to thoracic aortic aneurysms, thoracic
aortic dissections, and comorbidities associated with thoracic lesion repair
■
Knowledge of image interpretation, stent graft selection, and sizing
Physician Skills and Experience
All physicians must be trained in the use of the Valiant Navion thoracic stent graft system before using it.
Caution: The Valiant Navion thoracic stent graft system should only be used by physicians and teams trained in vascular
interventional techniques and in the use of this device.
The following list outlines the knowledge and skill requirements for physicians using the Valiant Navion thoracic stent graft
system:
■
Natural history and associated comorbidities of TAA, fusiform and saccular aneurysms or PAU, dissections, and BTAI
■
Radiographic, fluoroscopic, and angiographic image interpretation
■
Angioplasty
■
Appropriate use of anticoagulants (for example, heparin)
■
Appropriate use of radiographic contrast material
■
Embolization
■
Endovascular stent graft placement
■
Arterial cutdown, arteriotomy, and repair and percutaneous access and closure techniques
■
Nonselective and selective guidewire and catheter techniques
■
Snare techniques
■
Techniques to minimize radiation exposure
■
Device selection and sizing
Materials Recommended for Device Implantation
At the time of surgery, Medtronic recommends that the physicians have the following materials available:
■
All lengths and diameters of the devices necessary to complete the procedure, especially when preoperative case planning
measurements (treatment diameters/lengths) are not certain. This approach allows for greater intraoperative flexibility to
achieve optimal procedural outcomes.
■
Assorted angiographic catheters, angioplasty catheters, graduated pigtail catheters
■
Contrast media
■
Fluoroscope with digital angiography capabilities and the ability to record and recall imaging
■
Surgical suite in the event that emergency open conversion surgery is necessary
■
Heparin and heparinized saline solution
■
Transesophageal echocardiography (TEE)
■
Intravascular ultrasound catheter (IVUS)
■
Introducer sheaths for vascular access and to perform diagnostic imaging
■
Power injector
■
Radiopaque ruler
■
Reliant stent graft balloon catheter and other materials recommended by the Reliant Instructions for Use
■
Sterile lubricant
■
An assortment of stiff 0.035 in (0.89 mm) diameter guidewires, ≥ 260 cm in length
6.3. Recommended device sizing
Medtronic recommends that the Valiant Navion thoracic stent graft system be used according to the sizing configurations
provided in Table 2 through Table 5, and the sizing guidelines provided in Table 6 through Table 8. If preoperative case planning
measurements are not certain, an inventory of system lengths and diameters necessary to complete the procedure should be
available to the physician. This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.
Using this device outside the recommended anatomical sizing may result in serious device-related adverse events or clinical
events.
10 Instructions for Use English
The specific stent graft diameter used for treatment should be oversized relative to the nondiseased vessel, using the sizing
guidelines, to ensure appropriate radial fixation. Strict adherence to the sizing guidelines is expected when selecting the
appropriate device size. Table 6 through Table 8 describe the stent graft to vessel oversizing guidelines. Appropriate oversizing
has already been incorporated into the recommended sizes. Additional oversizing should not be incorporated. Sizing outside of
this range can result in endoleak, fracture, migration, infolding, or graft wear.
Table 2. FreeFlo Straight configurations
OD (Fr) Diameter (mm) Covered length (mm)
20 96
18
20
22
Table 3. CoveredSeal Straight configurations
OD (Fr) Diameter (mm) Covered length (mm)
18
20
22
Table 4. FreeFlo Tapered configurations
22
25
28 97, 174
31 97, 174, 229
34
37
40
46
20 94
22
25
28 90, 182
31 90, 182, 223
34
37
40
46
96, 185
59, 97, 174, 229
62, 103, 183, 22343
94, 180
52, 90, 182, 223
55, 95, 175, 21843
OD (Fr) Proximal × distal diameter (mm) Covered length (mm)
18 25×20 185
28×22
20
22
Table 5. CoveredSeal Tapered configurations
OD (Fr) Proximal × distal diameter (mm) Covered length (mm)
18 25×20 186
20
22
31×25
34×28
37×31
40×34
46×40
28×22
31×25
34×28
37×31
40×34
46×40
173
18543×37
207
20043×37
Instructions for Use English 11
6.4. Device sizing recommendations
Table 6. Sizing guidelines for the treatment of aneurysms
Vessel diameter indication (mm) Graft diameter (mm)
16–17 20
18–19 22
20–22 25
23–25 28
26–28 31
28–31 34
30–33 37
33–36 40
36–39 43
39–42 46
Table 7. Sizing guidelines for treatment of dissections
Vessel diameter indication (mm) Graft diameter (mm)
19 20
20-22 22
23-25 25
26-28 28
29-30 31
31-33 34
34-36 37
37-39 40
39-42 43
42-45 46
Table 8. Sizing guidelines for treatment of BTAI
Vessel diameter indication (mm) Graft diameter (mm)
16-17 20
18-20 22
20-23 25
23-26 28
26-29 31
28-32 34
30-35 37
33-38 40
36-41 43
39-44 46
Caution: Proper sizing of the Valiant Navion thoracic stent graft is the responsibility of the physician. This stent graft sizing
incorporates the recommended device oversizing for anatomical dimension and was based on in vitro test data. Additional
oversizing should not be incorporated.
Caution: Oversizing of the stent graft to the vessel by more than 10% may be unsafe in the presence of dissecting tissue or
intramural hematoma.
When multiple stent grafts are needed to exclude the target lesion, and the component junction or overlapping connection is not
supported by the nondiseased vessel (that is, it is in the aneurysm sac), the diameter of the inside component should be
oversized by 6 mm relative to the outside component. In the case when a 20 mm stent graft is used as an outside component,
the diameter of the inside component should be oversized by 5 mm relative to the outside component. If it is supported by the
vessel, the stent graft should be oversized relative to the supporting native vessel, as described in Table 6. In order to provide
the appropriate oversizing at a component junction, tapered configurations may need to be used.
The order of deployment when using multiple stent graft configurations may vary, depending on the diameter of the aorta
proximal to and distal to the lesion. Table 9 should be followed to determine the order of deployment when using multiple stent
graft configurations to treat non-dissected lesions.
12 Instructions for Use English
Caution: When treating acute dissections with multiple devices, deploy the proximal device first. Inadvertent pressurization of
the false lumen may result in retrograde dissection.
Note: If the vessel diameter and condition require variable proximal and distal diameter configurations, the smallest diameter
stent graft should be placed first, either at the proximal or distal end of the lesion.
Caution: The proximal end of a FreeFlo stent graft should never be placed inside the covered section of another stent graft.
Table 9. Order of deployment when using multiple stent graft component sections to treat non-dissected lesions
First section
implanted (primary section)
Second section
implanted
(additional section)
Proximal aortic diameter = distal
aortic diameter
Proximal main section implanted at
proximal end of lesion
Distal main section implanted with
correct junction oversizing. Due to
taper configuration of distal main
section, this fits a straight aorta cor-
Proximal aortic diameter > distal
aortic diameter
Distal main section (or other configuration if more appropriate) implanted at
distal end of lesion
Proximal main section implanted with
correct oversizing at junction with Distal
Main Section. Proximal telescoping of
devices fits this shape of aorta
Proximal aortic diameter <
distal aortic diameter
Proximal main section
implanted at proximal end of
lesion
Distal main section implanted with correct oversizing at
junction
rectly
Third section
implanted
(additional sec-
[Optional] additional sections implanted with correct oversizing at junction
[Optional] additional sections implanted
with correct oversizing at junction
[Optional] additional sections
implanted with correct oversizing at junction
tion)
7. Patient counseling information
The physician should review the following information when counseling the patient about this endovascular device and
procedure:
■
Details contained in the patient information booklet regarding possible complication after implantation of the device, such as
cardiac or neurological complications.
■
Differences between endovascular repair and open surgical repair
■
Risks related to open surgical repair
■
Risks related to endovascular repair
■
Pros and cons of open surgical repair and endovascular repair
■
Potential advantages of endovascular repair using a minimally invasive approach
■
Possibility that subsequent endovascular or open surgical repair may be required
■
Regular follow-up, including stent graft imaging, should be performed. For more information, refer to Section 12 (Follow-up
imaging recommendations).
■
Symptoms of aortic vessel rupture
■
Medtronic recommends that the physician disclose to the patient, in written form, all risks associated with treatment using
the Valiant Navion thoracic stent graft system. The list of potential risks occurring during and after implantation of the device
are provided in Adverse Events (Section 5). Medtronic also recommends that detailed patient specific risks also be
discussed. Additional counseling information can be found in the Patient Information Booklet.
8. How supplied
8.1. Sterility
Each Valiant Navion thoracic stent graft is individually contained within a delivery system. It is sterilized using electron beam
sterilization and is supplied sterile for single use only.
■
Do not reuse or attempt to resterilize.
■
Reuse of single-use devices may compromise the structural integrity of the device, essential material and design
characteristics, and/or lead to device failure.
■
If the device is damaged or the integrity of the sterilization barrier has been compromised, do not use the product. Contact
your Medtronic representative for return information.
8.2. Contents
■
One Valiant Navion thoracic stent graft system
■
One Instructions for Use or Web Leaflet
8.3. Storage
Store the system at room temperature in a dark, dry place.
Instructions for Use English 13
9. Summary of Clinical Studies
The Valiant Navion thoracic stent graft system is Medtronic's next generation thoracic stent graft system, based on the
previously approved Valiant™ thoracic stent graft with the Captivia™ delivery system (also referred to as the Valiant Captivia
thoracic stent graft system). The changes were intended to increase the range of stent graft sizes offered (shorter and longer
lengths, smaller diameter, and increased stent graft taper offered), reduce the delivery system profile (18 Fr, 20 Fr, and 22 Fr
instead of 22 Fr, 24 Fr, and 25 Fr), allow for the use of the CoveredSeal configuration as either the proximal or the distal device
(previous Closed Web configuration was limited to use as the distal device), and allow for controlled delivery of all
configurations.
Because the Valiant Navion thoracic stent graft system is expected to perform similarly to Valiant Captivia thoracic stent graft
system, the clinical study (Valiant Evo IDE study) was designed to confirm that the device design modifications did not
negatively impact clinical performance. The study was limited to the use of the device for the treatment of descending thoracic
aortic aneurysms (DTAA) and penetrating aortic ulcers (PAU). The results from this study, with consideration of the clinical data
from the evaluation of the Valiant Captivia thoracic stent graft system, in combination with the nonclinical testing, supports the
broad indication of all lesions of the descending thoracic aorta (DTA). The aortic anatomy associated with descending thoracic
aortic aneurysms is technically most challenging, making them suitable patients to evaluate acute outcomes per the objectives
of the Valiant Evo IDE study. Patients with aneurysm have been shown to be a worst-case population for endovascular repair of
the thoracic aorta through prior clinical experience from the Valiant Captivia thoracic stent graft system. The aneurysm disease
state is worst case when compared to transection and dissection disease states because the aneurysm poses additional
challenge for the delivery system in traversing the aneurysm to reach the deployment target and deploying accurately within the
short landing zone proximal to the aneurysm.
Note: Information regarding the clinical evaluation of the Valiant Captivia thoracic stent graft system to treat traumatic
transections, acute complicated dissections and DTAA can be found in the IFU for this device; Medtronic's VALOR II study
(Section 6.3 of the Valiant Captivia thoracic stent graft system IFU), Medtronic Dissection Trial (Section 6.1 of the Valiant
Captivia thoracic stent graft system IFU) and RESCUE study (Section 6.2 of the Valiant Captivia thoracic stent graft system
IFU).
Note: The Valiant Navion thoracic stent graft system was called the "Valiant Evo thoracic stent graft system" during the clinical
study. Therefore, the device is referred to as the “Valiant Evo” in this clinical study summary.
A total of 100 subjects were enrolled as part of the Valiant Evo IDE study. Data on the first 87 of these subjects are presented in
this clinical study summary [52 US, 35 OUS (6 Canada, 1 Denmark, 11 Italy, 8 France, 4 Netherlands, 5 UK)]. These
87 subjects were recruited from 31 medical centers worldwide, with 18 of the clinical sites coming from the United States and
13 from Outside the United States (OUS) (2 Canada, 1 Denmark, 4 Italy, 3 France, 2 Netherlands, and 1 UK). This clinical
study is a prospective, multi-center, single arm study.
The primary objective of the Valiant Evo IDE study was to demonstrate the safety and effectiveness of the Valiant Evo thoracic
stent graft system in subjects with a descending thoracic aortic aneurysm who were candidates for endovascular repair. The
primary endpoint was defined as the proportion of subjects with access failures, deployment failures, and/or Major Device
Effects (MDE) within 30 days post index procedure. For this study, access failure is defined as the inability to insert the device
due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure is defined as failure of
deployment due to subject anatomy or mechanical failure. MDEs are defined as the occurrence of any of the following: devicerelated secondary procedures, device-related mortality, conversion to open surgery, and thoracic aortic aneurysm rupture.
Notably, the definition of deployment failure used for this study does not include deployment accuracy, deployment without the
need for the use of bailout techniques, or the need for placing unintended additional devices.
This primary endpoint was selected based on Medtronic's review of the design characteristics/components that were leveraged
from the Valiant Captivia thoracic stent graft system to the Valiant Evo thoracic stent graft system. This review suggested that
the design changes should only potentially impact device delivery and acute clinical outcomes, not long-term device
performance. Access and deployment failures with the components of MDE comprise a clinically relevant measure of the
effects of the design modifications because this composite endpoint addresses the potential failures relevant to the
modifications. In addition, as MDEs are influenced little by aortic pathology, these measures are representative of device
performance and are relatively independent of lesion type. Finally, results of the VALOR II (IDE study for the Valiant Captivia
thoracic stent graft system in aneurysm conditions) clinical data showed that predominance of the MDEs occur within 30-days.
As a result, the Valiant Evo endpoint includes access and deployment failures and MDEs at 30 days that were defined to
include the potential clinical impacts that are related to the acute safety and effectiveness of stent graft placement.
Based on the Medtronic-sponsored VALOR II study results, the Valiant Evo IDE study was expected to meet the predetermined performance goal of 16% of MDE combined with access and/or deployment failures at 30 days. The sample size of
87 evaluable subjects provided 85% statistical power for the study hypothesis. The type I error was controlled with a one-sided
0.025. A total of 100 subjects, consecutively enrolled across 37 sites in all geographies, ensured that 87 evaluable subjects
(52 US, 35 OUS) were available at the 30-day primary endpoint for analysis.
14 Instructions for Use English
Secondary objectives of the study included descriptive analyses of secondary endpoints, acute procedural observations and
clinical utility measures. Secondary endpoints included adverse events, MDEs, secondary procedures, all-cause mortality
(ACM), aneurysm-related mortality (ARM), loss of stent graft patency, endoleaks, stent graft migration and aneurysm
expansion.
Data were collected at baseline, during the implant procedure, and at discharge. Subjects were evaluated at 30 days and
12 months. For subjects enrolled in the US, an evaluation at 6 months was also required per the clinical investigation plan.
Safety and effectiveness data on the Valiant Evo thoracic stent graft system will be collected by following all enrolled subjects to
2 years and those who signed an updated Informed Consent Form for a total of 5 years.
A Clinical Events Committee (CEC) met to adjudicate MDEs, unanticipated adverse device effects (UADEs), unanticipated
serious adverse device effects (USADEs), deaths, and all aneurysm ruptures for the global cohort. A Data Monitoring
Committee (DMC) met to evaluate safety data during the course of the clinical study. A central imaging core lab was used to
provide independent evaluation of imaging findings.
9.1. Core Lab Imaging Accountability
A total of 100 subjects were enrolled in this study. The analysis for the study was based on the first 87 subjects evaluable for
the 30-day endpoint. The data cutoff for this analysis was 11/DEC/2017.
These 87 subjects were enrolled in this study between March 2016 and October 2017. All subjects underwent endovascular
repair with the Valiant Evo thoracic stent graft. Table 10 summarizes the subject accountability and compliance by study interval
in the global cohort for these 87 subjects.
Table 10. Subject and Core Lab Imaging Accountability – All Subjects
Follow-up
(Interval)
Subject Follow-up
Eligi-
ble
Clini-
low-
cal
Fol-
up
Imag-
ing
Fol-
low-
up
Subjects
with Imaging
(Core Lab)
CT
\MR
Other
Imag-
ing
Imag-
ing
Subjects with Adequate
Imaging to Assess the
Parameter (Core Lab)
Loss
of
PatencyEndo-
a
leak
Migra
tion
Aneur
ysm
Expa
nsion
Subject Events Occurring before Next
Visit
No
Impla
nt
Con-
ver-
sion
to
Surgery Death
With-
drawa
l/Earl
y Termina-
tion
Lost
to
Fol-
low-
up
Not
Due
for
Next
Visit
Enrollment 87 0
Events
after
Implant but
0 1 0 0 0
before 1Month Visit
1-Month
Visit
(Day 1-90)
86
85
(99%)84(98%)84(98%)0(0.0%)81(94%)81(94%)
Events
after 1Month but
0 4 2 0 29
before 6Month Visit
6-Month
Visit (Day
91-304)
b
51
36
(71%)36(71%)36(71%)0(0.0%)31(61%)31(61%)35(69%)36(71%)
Events
after 6Month but
0 1 0 0 26
before 12Month Visit
12-Month
Visit (Day
24
305-548)
a
Other imaging includes chest X-ray, angiogram, ultrasound, and other imaging of the stent graft region.
b
6-month data is not required per OUS protocol; therefore, the follow-up rate is lower when US and OUS results are combined at this timepoint.
22
(92%)21(88%)21(88%)0(0.0%)21(88%)21(88%)21(88%)21(88%)
Note: In Table 10, data analysis sample size varies for each of the timepoints above and in the following tables. This variability
is due to subject availability for follow-up, as well as, quantity and quality of images available from specific timepoints for
Instructions for Use English 15
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