THE ENDURANT STENT GRAFT SYSTEM IFU
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The Endurant
™
Stent Graft System
Instructions for Use (IFU)
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IMPORTANT!
• Do not attempt to use the Endurant Stent Graft System before completely reading and understanding
the information contained in the Instructions for Use.
• Carefully inspect all product packaging for damage or defects prior to use. Do not use product if any
sign of damage or breach of the sterile barrier is observed.
• These devices are supplied STERILE for single use only. After use, dispose of the delivery catheters in
accordance with hospital, administrative, or government policies. Do not resterilize.
• Caution: Federal (USA) law restricts this device for sale by or on the order of a physician.
THE ENDURANT STENT GRAFT SYSTEM IFU
THE ENDURANT STENT GRAFT SYSTEM IFU
Explanation of symbols on product labeling
Refer to the device labeling to see which symbols apply to this product.
Contents: One device
Do not use if package is damaged
Consult instructions for use at: www.medtronic.com/manuals
Non-pyrogenic
Peel here
Store at room temperature in a dark, dry place
MR Conditional
CAUTION: Federal (USA) law restricts this device for sale by or on
order of a physician
Sterilized using irradiation
Catalogue number
Serial number
Use by
Do not reuse
Manufacturer
Manufactured In
THE ENDURANT STENT GRAFT SYSTEM IFU
© 2021 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
THE ENDURANT STENT GRAFT SYSTEM IFU
Table of Contents
1. DEVICE DESCRIPTION 1
2. INDICATIONS FOR USE 4
3. CONTRAINDICATIONS 4
4. WARNINGS AND PRECAUTIONS 4
5. ADVERSE EVENTS 6
6. SUMMARY OF CLINICAL STUDY 7
7. PATIENT SELECTION AND TREATMENT 24
8. HOW SUPPLIED 24
9. CLINICAL USE INFORMATION 25
10. IMPLANT INSTRUCTIONS 27
11. BAIL-OUT TECHNIQUES 33
12. FOLLOW-UP IMAGING RECOMMENDATIONS 34
13. ADDITIONAL SURVEILLANCE AND TREATMENT 35
14. DISCLAIMER OF WARRANTY 35
15. DEVICE REGISTRATION 35
THE ENDURANT STENT GRAFT SYSTEM IFU
THE ENDURANT STENT GRAFT SYSTEM IFU
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1 DEVICE DESCRIPTION
The Endurant™ Stent Graft System is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms using an
endovascular approach. When placed within the aneurysm, the Endurant™ Stent Graft provides a permanent, alternative
conduit for blood flow within the patient's vasculature.
The stent graft system is comprised of 2 main components: the implantable Endurant Stent Graft and the disposable
Endurant™ Delivery System. The stent graft is preloaded into the delivery system and advanced to the aneurysm using
fluoroscopic guidance. Upon deployment, it self-expands to conform to the shape and size of the seal zones above and
below the aneurysm.
1.1 Stent Graft
The Endurant Stent Graft (Figure 1) has 2 main components: an aorto-iliac bifurcated component and a contralateral limb.
Additional components include aortic and iliac extensions. After placement of the bifurcated component, the contralateral
limb and additional components are introduced separately into the vessel and mated with the implanted component(s).
All stent graft components are composed of nitinol stents sewn to a fabric graft. Radiopaque 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.
Stent graft components should be oversized to be larger than the measured vessel inner diameter (aortic components are
oversized approximately 10-20%; limb components are oversized approximately 10-25%). Section 9.2 contains detailed
sizing information for all stent graft components, including available ranges of length and diameter. Table 1 contains a
summary of the stent graft materials.
Figure 1: Endurant Stent Graft Components
Note: This and all other product graphics appearing in this manual are not drawn to scale.
1. Radiopaque Marker
2. ‘e’ Marker
3. Radiopaque Gate Marker
4. Aortic Extension
5. Bifurcated Component
6. Iliac Extension
7. Contralateral Limb
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Component
Material
Stents
Nickel-Titanium (Nitinol) Alloy
Button Radiopaque Markers
Platinum-Iridium Alloy
“e” Radiopaque Marker
Platinum
Contralateral Gate Marker
Gold
Graft Fabric
Polyester
Suture
Polyester and Polyethylene
The Endurant Stent Graft System does not contain natural rubber latex; however, during the manufacturing process, it
may have incidental contact with latex.
1.1.1 Bifurcated Component
The proximal section of the bifurcated component deploys into the proximal neck and upper section of the aneurysm. The
proximal aortic section of the bifurcated component is composed of Nitinol stents sewn to a fabric graft. The suprarenal
portion of the proximal stent is not covered with graft fabric (Figure 1). The suprarenal stent has anchor pins to fix the
stent graft in place.
The aortic section distally bifurcates into 2 smaller tubes: an ipsilateral single iliac limb and a short contralateral leg. The
ipsilateral limb stents are sewn to the outside of the graft fabric creating a smooth inner lumen. The contralateral leg
stents are sewn to the inside of the graft fabric (Figure 1).
1.1.2 Contralateral Limb Component
The proximal end of the contralateral limb component deploys within the short contralateral leg of the bifurcated
component, while the distal end of the contralateral limb component deploys into the contralateral iliac artery. The
proximal section of the contralateral limb component has an open web configuration (Figure 1), which contains no graft
material in its stent valleys.
1.1.3 Iliac Extension Component
If additional distal stent graft length is needed, iliac extension components are available. The iliac extension component
has an open web configuration on its proximal end.
1.1.4 Aortic Extension Component
If additional proximal stent graft length is needed, aortic extension components are available. The aortic component has a
bare proximal suprarenal stent with anchor pins.
Table 1: Stent Graft Materials
1.2 Delivery System
The Endurant Delivery System, based on the Xcelerant™ Delivery System consists of a single-use, disposable catheter,
with an integrated handle to provide accurate, controlled deployment. The catheter assembly is flexible and compatible
with a 0.035 in (0.89 mm) guidewire. There are 2 types of Endurant delivery systems: the Endurant Aortic Delivery System
(Figure 2) delivers the bifurcated component and aortic extension. The Endurant Iliac Delivery System (Figure 3) delivers
the contralateral limb and iliac extension. The aortic delivery system features a tip capture mechanism, which is not
present in the iliac delivery system.
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1. Rear Handle
Figure 2: Aortic Delivery System
2. Back-End Wheel
3. Screw Gear
4. External Slider
5. Trigger
6. Front Grip
7. Graft Cover
8. Markerband
9. Spindle
10. Sleeve
11. Tapered Tip
1. Rear Handle
Figure 3: Iliac Delivery System
2. Screw Gear
3. External Slider
4. Trigger
5. Front Grip
6. Graft Cover
7. Markerband
8. Tapered Tip
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2 INDICATIONS FOR USE
The Endurant Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac
aneurysms in patients with the following characteristics:
• Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories
• Proximal neck length of ≥10 mm
• Infrarenal neck angulation of ≤60°
• Distal fixation length of ≥15 mm
• Aortic neck diameters with a range of 19 to 32 mm
• Iliac diameters with a range of 8 to 25 mm
• Morphology suitable for aneurysm repair
3 CONTRAINDICATIONS
The Endurant Stent Graft System is contraindicated in:
• Patients who have a condition that threatens to infect the graft.
• Patients who are sensitive to or have allergies to the device materials listed in Table 1.
Also consider the information in Section 4.2, Patient Selection.
4 WARNINGS AND PRECAUTIONS
Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions may lead to
serious consequences or injury to the patient.
4.1 General
• The Endurant Stent Graft System should only be used by physicians and teams trained in vascular interventional
techniques, including training in the use of this device. Specific training expectations are described in Section 9.1,
Physician Training Requirements.
• Always have a vascular surgery team available during implantation or reintervention procedures in the event that
conversion to open surgical repair is necessary.
4.2 Patient Selection
• The long-term safety and effectiveness of the Endurant Stent Graft System has not been established.
• Do not use the Endurant Stent Graft System in patients unable to undergo, or who will not be compliant with, the
necessary preoperative and postoperative imaging and implantation procedure described in Sections 9 - 12.
• The Endurant Stent Graft System is not recommended in patients who cannot tolerate contrast agents necessary for
intra-operative and post-operative follow-up imaging.
• The Endurant Stent Graft System is not recommended in patients exceeding weight and/or size limits necessary to
meet imaging requirements.
• Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck
angulation (>60°); short proximal aortic neck (<10 mm); and thrombus and/or calcium formation at the arterial
implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Irregular calcification and/or
plaque may compromise the fixation and sealing of the implantation sites. Necks exhibiting these key anatomic
elements may be more conducive to graft migration.
• Deploying the stent graft in an area of vessel calcification may lead to abrasion of the stent graft on calcified plaque,
potentially causing development of holes or tears in the graft.
• Iliac conduits may be used to ensure the safe insertion of the delivery system if the patient’s access vessels, as
determined by treating physician, preclude safe insertion of the delivery system.
• Inappropriate patient selection may result in poor device performance or device performance not otherwise in
accordance with the specifications.
• The safety and effectiveness of the Endurant Stent Graft System has not been evaluated in patients who:
• Are less than 18 years of age
• Are pregnant or lactating
• Have an aneurysm that is:
o Suprarenal
o Juxta-renal/ Para-renal
o Isolated ilio-femoral
o Mycotic
o Inflammatory
o Pseudoaneurysm
• Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior mesenteric
artery
• Have an untreated thoracic aneurysm >4.5 cm in diameter
• Requires emergent aneurysm treatment, e.g., trauma or rupture
• Have a history of bleeding diathesis or coagulopathy
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• Have had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation
• Have a reversed conical neck defined as a >4 mm distal increase over a 10 mm length
• Have a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is
not amenable to pre-treatment
• Have significant (typically >25% of vessel circumference of aortic neck and iliac artery, and/or >50% of the
length of the iliac artery) aortic mural thrombus at either the proximal or distal attachment centers that would
compromise fixation and seal of the device bilaterally
• Have ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
• Have arterial access site that is not expected to accommodate the diameter of the device (14F-20F) due to size
or tortuosity
• Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture
and/or leukocytosis (WBC >11,000 mm
• Have congenital degenerative collagen disease, e.g., Marfan’s Syndrome
• Have a creatinine >2.0 mg/dl
• Are on dialysis
• Have connective tissue disorder
• All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health
and performance of the implanted endovascular stent 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 Section 12, Follow-up Imaging Recommendations.
• Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary
interventions or surgical procedures.
• Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered
for patients experiencing enlarging aneurysms and/or endoleak. An increase in aneurysm size and/or persistent
endoleak may lead to aneurysm rupture.
3
) that is treated with antimicrobial agents (nonprophylactic)
4.3 Before Implant
• Pre-operative planning for access and placement should be performed before opening the device packaging.
• Carefully inspect the Endurant Stent Graft System packaging and system for damage or defects prior to use. Do not
use product if any sign of damage or breach of the sterile barrier is observed. Do not attempt to resterilize the
Endurant Delivery System or the Endurant Stent Graft Components.
• Do not bend, kink, or otherwise alter the Endurant Delivery System prior to implantation because it may cause
deployment difficulties.
• To reduce the risk of thrombotic problems, an additional bolus of IV heparin should be administered before inserting
the device.
4.4 During Implant
• Exercise care in handling and delivery technique to help prevent vessel rupture.
• Studies indicate that the danger of micro-embolization increases with increased procedure duration.
• Renal complications may occur:
• Do not deploy the stent graft components in a location that could cause an endoleak or occlude arteries necessary to
supply bloodflow to organs or extremities. This could necessitate surgical removal of the device.
• Use fluoroscopic guidance to advance the delivery system and to detect kinking or alignment problems with the stent
graft components. Do not use excessive force to advance or withdraw the delivery system when resistance is
encountered. If the delivery system kinks during insertion, do not attempt to deploy the stent graft component.
Remove the device and insert a new delivery system.
• Do not continue to torque the delivery system without tip response.
• Exercise particular care in difficult areas, such as areas of stenosis, intravascular thrombosis, or in calcified or
tortuous vessels. Consider performing balloon angioplasty at the site of a narrowed or stenotic vessel, and then
attempt to gently reintroduce the catheter delivery system.
• Inadequate seal zone may result in increased risk of leakage into the aneurysm or migration of the stent graft.
• Systemic anticoagulation should be used during the implantation procedure based on hospital or physician protocol.
If heparin is contraindicated, an alternative anticoagulant should be considered.
• Stent graft components cannot be replaced or drawn back into the delivery system, even if the stent graft component
is only partially deployed.
• If the graft cover is accidentally withdrawn, the device will prematurely deploy and may be incorrectly positioned.
• When deploying the stent graft, be sure to hold the front grip of the delivery system stationary.
• If a balloon catheter is used, do not over-inflate or inflate outside the graft material. Follow all manufacturer
instructions regarding catheter operation.
• High pressure injections of contrast media made at the edges of the stent graft immediately after implantation may
cause endoleak.
o from an excess use of contrast agents
o as a result of embolic or misplaced stent graft
4.5 Treatment and Follow-up
• Any endoleak left untreated during the implantation procedure must be carefully monitored after implantation.
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• Additional treatment including endovascular treatment or surgical conversion should be strongly considered in the
following cases:
• All patients with endovascular aneurysm repair should undergo periodic imaging to evaluate the stent graft,
aneurysm size, and occlusion of vessels in the treatment area. Significant aneurysm enlargement (>5 mm), the
appearance of a new endoleak, evidence of perigraft flow, change in aneurysm pulsatility, or migration resulting in an
inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or
surgical conversion.
• Non-clinical testing has demonstrated that the Endurant Stent Graft System is MR Conditional. It can be scanned
safely in both 1.5T and 3.0T MR systems only using the specific testing parameters listed in Section 9.6,MRI
Information.
o Aneurysm growth >5 mm (with or without endoleak) since last follow-up.
o Change in aneurysm pulsatility (with or without growth or endoleak).
o Persistent endoleak (with or without aneurysm growth).
o Stent graft migration resulting in an inadequate seal zone.
o Decrease in renal function due to renal artery occlusion (migration or poor placement).
5 ADVERSE EVENTS
5.1 Observed Adverse Events
Major adverse events observed in the clinical study supporting approval of the device are provided in Section 6.5.1, Table 10 through Table 13.
5.2 Potential Adverse Events
Adverse events that may occur or require intervention include, 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 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
• 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., confusion, stroke, transient
ischemic attack, paraplegia, paraparesis, paralysis)
• Occlusion of device or native vessel
• Pulmonary complications and subsequent attendant problems
• Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency,
failure)
• Stent graft: improper component placement; incomplete component deployment; component migration; suture break;
occlusion; infection; stent fracture; graft twisting or kinking; insertion and removal difficulties; graft material wear;
dilatation; erosion; puncture and perigraft flow
• Surgical conversion to open repair
• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula,
dissection.
• Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death)
• Vessel damage
• Wound complications and subsequent attendant problems (eg, dehiscence, infection, hematoma, seroma, cellulitis)
5.3 Device-Related Adverse Events Reporting
Any adverse event or clinical incident involving the Endurant Stent Graft System should be immediately reported to
Medtronic Vascular. To report an incident in the US, call (800) 465-5533.
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6 SUMMARY OF CLINICAL STUDY
The objective of the Endurant Stent Graft System US Clinical Study was to evaluate the safety and effectiveness of the
Endurant Stent Graft System in the treatment of infrarenal abdominal aortic and aorto-iliac aneurysms. The study was a
controlled, prospective, non-randomized, multi-center trial. 150 subjects were enrolled across 26 United States’ sites. The
Endurant Test Group was compared to subject data from the Talent™ IDE study.
The analysis included endpoints that are consistent with current literature and other endovascular aneurysm repair
(EVAR) clinical studies. The primary safety endpoint for this analysis was the proportion of patients free from a MAE
within 30 days of the index procedure (based on a composite MAE rate), compared to the Talent Control Group. The
primary effectiveness endpoint for this analysis was successful aneurysm treatment at 1 year. Successful aneurysm
treatment was an endpoint that included successful delivery and deployment, aneurysm growth, endoleaks, stent graft
occlusion, conversion to surgery, rupture and migration. Secondary study endpoints and analyses were also presented.
Follow up evaluations were conducted at 1 month, 6 months, 12 months, and will be conducted annually thereafter for a
total of 5 years from the index procedure.
In addition, as part of the conditions of approval, Medtronic performed a post-approval study (PAS) to evaluate the safety
and effectiveness of the Endurant Stent Graft system through 5 years of implantation. This evaluation was conducted via
the ENGAGE PAS study. Details regarding the Endurant stent graft US clinical study and the ENGAGE PAS follow-up
evaluations through 5 years is provided in the Endurant II/IEndurant IIs Stent Graft System IFU (manual document
number M052195T001) available on manuals.medtronic.com.
6.1 Subject Accountability and Follow-up
For the Endurant Test Group, all 150 enrolled subjects were eligible for clinical and imaging follow-up at 1-month. Of the
150 subjects, 99% (149/150) had a both a clinical follow-up and imaging follow-up. Through the first 12 months, 6 subjects
died and none withdrew or was lost to follow-up. At the 12-month follow-up interval, 132 subjects were eligibile for clinical
and imaging follow-up and 12 subjects were pending for the 12-month visit. Of the 132 subjects, 97% (128/132) had a
clinical follow-up and 98% (129/132) had an imaging follow-up.
Detailed subject accountability and follow-up are presented in Table 2.
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