Medtronic CVF3616C124XH Instructions for Use
Talent® Converter Stent Graft
with Xcelerant® Hydro Delivery System
Instructions for Use
• Do not attempt to use the Talent Converter Stent Graft with Xcelerant Hydro
Delivery System before completely reading and understanding the information
contained in this booklet.
• Carefully inspect all product packaging for damage or defects prior to use. Do not
use this 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, and/or government
policy. Do not resterilize.
• Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a
physician
IMPORTANT!
Talent® Converter Stent Graft with Xcelerant Hydro Delivery System
Instructions for Use
Table of Contents
Section Page
1.0 DEVICE DESCRIPTION ......................................................................................................4
1.1 Device Components .........................................................................................................4
1.2 Xcelerant Hydro Delivery System (HDS) ..........................................................................6
2.0 INDICATIONS......................................................................................................................7
3.0 CONTRAINDICATIONS ......................................................................................................7
4.0 WARNINGS AND PRECAUTIONS .....................................................................................7
4.1 General.............................................................................................................................7
4.2 Patient Selection...............................................................................................................8
4.3 Implant Procedure ............................................................................................................9
4.4 Magnetic Resonance Imaging (MRI) Safety...................................................................10
5.0 ADVERSE EVENTS ..........................................................................................................10
5.1 Potential Adverse Events ...............................................................................................10
5.2 Device-Related Adverse Events Reporting ....................................................................11
6.0 SUMMARY OF CLINICAL STUDY ...................................................................................11
7.0 PATIENT SELECTION AND TREATMENT ......................................................................11
7.1 Individualization of Treatment.........................................................................................11
8.0 PATIENT COUNSELING INFORMATION ........................................................................12
9.0 HOW SUPPLIED ...............................................................................................................12
10.0 CLINICAL USE INFORMATION......................................................................................13
10.1 Patient selection: ..........................................................................................................13
10.2 Physician skills and experience:...................................................................................13
10.3 Materials Recommended for Device Implantation .......................................................13
10.4 Converter Sizing Guidelines .........................................................................................14
11.0 DIRECTIONS FOR USE: TALENT CONVERTER STENT GRAFT WITH
XCELERANT HDS...................................................................................................................17
11.1 Pictorial References .....................................................................................................17
11.2 Vascular Access and Arteriotomy ................................................................................17
11.3 Implantation of the Converter Stent Graft.....................................................................17
11.4 Deploy Distal End .........................................................................................................21
11.5 Delivery System Removal ............................................................................................21
11.6 Placement of the iliac extensions .................................................................................22
11.7 Stent Graft Balloon Modeling........................................................................................23
11.8 Occluder Placement .....................................................................................................23
11.9 Procedure Completion..................................................................................................24
11.10 Femoral-to-Femoral Crossover ..................................................................................24
11.11 Entry Site Closure.......................................................................................................24
11.12 Handle Dis-assembly Technique................................................................................24
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12.0 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP..................................25
12.1 General.........................................................................................................................25
12.2 Contrast And Non-Contrast CT Recommendations .....................................................26
12.3 Abdominal Radiographs ...............................................................................................26
12.4 Ultrasound ....................................................................................................................27
12.5 MRI Safety and Compatibility .......................................................................................27
13.0 ADDITIONAL SURVEILLANCE AND TREATMENT ......................................................28
14.0 POST APPROVAL REGISTRY .......................................................................................28
15.0 DEVICE – RELATED ADVERSE EVENTS REPORTING...............................................28
16.0 DEVICE REGISTRATION PACKET................................................................................28
17.0 CONFIGURATIONS AVAILABLE ...................................................................................30
18.0 EXPLANATION OF SYMBOLS.......................................................................................32
List of Tables
Table 1: Stent Graft Materials ..................................................................................................4
Table 2: Sizing guidelines for the Talent Converter Stent Graft deployed Flush within the
Talent /AneuRx Bifurcated Stent Grafts.................................................................................14
Table 3: Talent Converter Stent Graft with Xcelerant HDS Sizing Guidelines .......................16
Table 4: Recommended Imaging Schedule for Talent Converter Stent Graft Patients .........26
Table 5: Accepted Imaging Protocols ....................................................................................26
Table 6: Converter Stent Grafts with the Xcelerant Hydro Delivery System.......................... 30
Table 7: Iliac Extensions with the Xcelerant Hydro Delivery System .....................................31
List of Figures
Figure 1: Overview of Talent Converter Stent Graft................................................................. 5
Figure 2: Talent Converter Stent Graft with the Xcelerant HDS ..............................................6
Figure 3: Introduction of the Converter System .....................................................................18
Figure 4: Position the system.................................................................................................19
Figure 5: Deploy Proximal End ..............................................................................................20
Figure 6: Deploy the Distal End .............................................................................................20
Figure 7: Use the Quick Disconnect to Retract the Tapered Tip ...........................................21
Figure 8: Remove the Delivery System..................................................................................22
Figure 9: Iliac Extension.........................................................................................................22
Figure 10: Stent Graft Balloon Modeling ................................................................................23
Figure 11: Occluder Placement ............................................................................................. 24
Figure 12: Overview of Talent Converter Stent Graft............................................................. 30
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1.0 DEVICE DESCRIPTION
The Talent
components: an implantable stent graft and a disposable delivery system. The pre-loaded stent graft is advanced
to the aneurysm location over a guide wire and, upon retraction of the graft cover, expands to the indicated
diameter.
The Talent Converter Stent Graft component is comprised of nitinol metal springs attached to polyester fabric graft
material. The proximal and distal springs are attached to connecting bars to provide additional columnar strength
to the stent graft. The springs are sewn to the polyester fabric graft using polyester suture material. Radiopaque
markers, made out of platinum-iridium in the shape of a figure eight (a.k.a., Figur8), are sewn onto the stent graft
to aid in visualization of the stent graft under fluoroscopy and to facilitate accurate placement of the device. See
Table 1 for a listing of stent graft materials and Figure 1 for an overview of the Talent Converter Stent Graft.
The Talent Converter Stent Graft is designed to be placed within in a Talent or AneuRx Bifurcated Stent Graft for
secondary endovascular treatment of the bifurcated stent grafts. See Table 2 and Table 3 for sizing guidelines and
Section 17.0 for available device configurations.
®
Converter Stent Graft with the Xcelerant® Hydro Delivery System (HDS) is comprised of two (2) main
Table 1: Stent Graft Materials
Stent Graft Component Material
Springs Nitinol wire (Nickel-Titanium alloy)
Connecting Bar Nitinol wire (Nickel-Titanium alloy)
Mini-Support Spring (FreeFlo only) Nitinol wire (Nickel-Titanium alloy)
Stent Fabric Woven polyester
Sutures Braided polyester suture
Figur8 Radiopaque Markers Platinum-Iridium wire
1.1 Device Components
The Talent Converter Stent Graft configuration is described in the following section.
1.1.1 Talent Converter Stent Graft
The proximal end of all Talent Converter Stent Grafts has a bare spring that is not covered with
graft material to allow for supra-renal fixation. Converter Stent Grafts with a proximal diameter
greater than 22 mm have a mini-support spring to aid in sealing. The proximal end configuration in
which a bare spring and mini-support spring are present is called the ‘FreeFlo’ configuration. The
proximal end configuration in which a bare spring is present without a mini-support spring is called a
‘Bare Spring’ configuration. The distal iliac ends of the stent graft have Closed W eb configurations
and are 16 mm in diameter.
The Talent Converter Stent Graft with Xcelerant Hydro Delivery System is indicated for secondary
endovascular intervention in patients having received prior endovascular repair of abdominal aortic
aneurysms (AAA) using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate
proximal fixation, seal, overlapping of modular components or unattainable contralateral limb
cannulation.
The Converter component can be placed into the pre-existing Talent or AneuRx Bifurcated Stent
Graft, with the proximal edge of the graft material:
a. Deployed flush with the fabric edge of the pre-existing bifurcated stent graft
b. Deployed up to a maximum of 34 mm proximally to the fabric edge of the pre-existing
The distal end of the Converter is placed into the ipsilateral limb of the bifurcated stent graft.
A femoral-femoral artery bypass, combined with the placement of a Talent Occluder component, is
typically performed in order to exclude retrograde blood flow from the other iliac artery into the
aneurysm sac.
bifurcated stent graft
Figure 1: Overview of Talent Converter Stent Graft
FreeFlo Configuration Shown
[22mm size has Bare Spring configuration
without mini-support spring (not shown in
the figure)]
Closed Web
Configuration
22-36 mm
124-126 mm
Note: Figure 1 is a representation only. The Talent Converter Stent Graft may appear differently when viewed
under fluoroscopy.
16mm
= Figur8 Radiopaque Marker
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1.2 Xcelerant Hydro Delivery System (HDS)
The stent graft is loaded inside the Xcelerant HDS. The Xcelerant HDS is a hydrophilic coated delivery
system, as shown in Figure 2, which facilitates the placement of the stent graft via the arterial
vasculature (for example, femoral arteries). Using fluoroscopic guidance, the Xcelerant HDS is properly
positioned within the patient’s vasculature and the stent graft is deployed from the Xcelerant HDS.
The Xcelerant HDS consists of:
• A single use, disposable system with an integrated handle to provide the user with controlled
deployment
• A flexible catheter assembly compatible with a 0.035” guide wire
• Three (3) concentric single lumen polymer shafts (an outer hydrophilic coated graft cover shaft with
an inner member shaft, and a guide wire lumen)
• A polymeric, atraumatic tip attached at the distal end to facilitate tracking through tortuous and
calcified vessels
• A radiopaque tip, a marker at the distal end of the stent graft, and a marker on the distal end of the
graft cover to aid in fluoroscopic visualization
• O-rings contained within the delivery system to maintain hemostasis during the procedure
Retraction of the graft cover allows deployment of the self-expanding stent graft. Post deployment, the
physician will recapture the tip of the delivery system by retracting the inner member.
Figure 2: Talent Converter Stent Graft with the Xcelerant HDS
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B
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A
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12
Detail A
13
Detail B
1. Stent Stop 8. Trigger
2. Graft Cover 9. Front Grip
3. RO Marker 10. Handle
4. RO Tapered Tip Disassembly Ports
5. Rear Grip 11. Strain Relief
6. Screw Gear 12. Touhy Bourst
7. Slider 13. Quick Disconnect
2.0 INDICATIONS
The Talent Converter Stent Graft with Xcelerant Hydro Delivery System is indicated for secondary endovascular
intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac
aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal,
overlapping of modular components or unattainable contralateral limb cannulation.
The anatomical considerations are as follows:
• Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or
accessories
• Adequate proximal fixation site:
• Adequate distal fixation site:
• with a length from the lowest renal artery to the proximal fabric edge of the previously placed
bifurcated stent graft between 0 mm and 34 mm
• with a vessel diameter of ≥ 18 mm and ≤ 32 mm
• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm
• For the converter used without an iliac extension the landing zone of the distal fixation site within
the bifurcated graft segment of ≤ 16 mm in diameter and at least 30 mm in overlap length (between
the bifurcation and distal end of the Talent Converter)
• For the Converter used in combination with an iliac extension, distal fixation site within the iliac
artery greater than 15 mm in length and 8 mm to 22 mm in diameter
3.0 CONTRAINDICATIONS
The Talent Converter Stent Graft is contraindicated in:
• Patients who have a condition that threatens to infect the graft
• Patients with sensitivities or allergies to the device materials (see Table 1)
• Patients with a pre-existing iliac extension with a distal diameter of ≤ 8 mm
4.0 WARNINGS AND PRECAUTIONS
4.1 General
Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may
lead to serious consequences or injury to the patient.
• The Talent Converter Stent Graft System should only be used by physicians and teams trained in
vascular interventional techniques. Additionally, the Converter Stent Graft should only be used by
those who have received both general Talent Xcelerant Hydro training and training in the use of this
device. Specific training expectations are described in Section 10.0
• Always have a vascular surgery team available during implantation or reintervention procedures in
the event that conversion to open surgical repair is necessary
• The Talent Converter is not intended as a stand alone device to repair abdominal aneurysms.
Rather, the Talent Converter is used for secondary repair of previously placed Talent or AneuRx
Bifurcated Stent Grafts or in cases where contralateral gate cannulation is unattainable at the time
of the index procedure
• The Talent Converter Graft is designed to provide adequate proximal fixation but may not address
deficiencies in previously implanted endovascular grafts or correct the clinical problem caused by
the pre-existing graft
• Medtronic has conducted testing to evaluate mechanical interactions between the Talent Converter
Stent Graft and the pre-existing Talent or AneuRx Bifurcated Stent Graft. The Talent Converter
Stent Graft has not been evaluated for use with any other commercially available bifurcated stent
grafts
• Monitoring of the Talent Converter and pre-existing graft combination through clinical and imaging
follow-up is required after implantation of the Talent Converter for the following reasons:
• all endovascular grafts require follow-up to ensure continued success of the treatment over
time
• the Talent Converter is intended to be used with a pre-existing endovascular graft having
inadequate proximal fixation/seal or with unattainable contralateral limb cannulation during the
index procedure. It may not prevent migration of the pre-existing graft
• a variety of endovascular graft failure modes, and considerable variability in anatomy and
health status between patients precluded evaluation of the Talent Converter in every possible
clinical situation to determine patient outcome
• The long-term performance of endovascular grafts with secondary endovascular intervention using
additional components has not yet been established. All patients receiving the Talent Converter
should receive enhanced follow-up. Specific follow-up guidelines are described in Section 12.0,
Imaging Guidelines
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• 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 (for example, endoleaks, enlarging aneurysms or changes in the structure or position of the
endovascular graft component) should receive enhanced follow-up. Specific follow-up guidelines
are described in Section 12.0, Imaging Guidelines
• Patients should be counseled on the importance of adhering to the follow-up schedule, both during
the first year and at least yearly intervals thereafter. More frequent follow-up may be appropriate for
all patients receiving the Talent Converter until stability of the Talent Converter, pre-existing graft,
and aneurysm has been established
• After secondary endovascular intervention, patients should be regularly monitored for perigraft flow,
aneurysm growth or changes in the structure or position of the endovascular graft. At a minimum,
imaging should include: 1) abdominal radiographs to examine device integrity (separation between
components or stent fracture) and 2) contrast and non-contrast CT to examine aneurysm changes,
perigraft flow, patency, tortuosity and disease progression. Only patients with renal complications
or other factors precluding the use of image contrast media should be monitored using non-contrast
CT and duplex ultrasound or MRI
• Intervention or conversion to standard open surgical repair following initial endovascular repair
should be considered for patients experiencing enlarging aneurysms, unacceptable fixation length
(both the vessel and component overlaps) 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 and/ or leaks may be required to
undergo secondary interventions or surgical procedures
4.2 Patient Selection
• In patients with previously implanted AneuRx bifurs, avoid deployment of the Talent Converter in
cases which can result in configurations involving three (3) or more layers of graft material overlap
where the diameter of the landing zone is ≤ 13 mm. This could potentially cause graft material
infolding which may compromise vessel patency
• Care should be exercised in patients receiving the Talent Converter Stent Graft with possible
deployment configurations involving four (4) or more layers of stent graft material overlap, as
patency may be compromised. (An example where such an overlap may arise is when a Talent
Converter with an iliac extension needs to be deployed within a bifur with an iliac extension)
• Lack of non-contrast CT imaging may result in failure to appreciate iliac or aortic calcification, which
may preclude access or reliable device fixation and seal
• Pre-procedure CT slice thickness >3 mm may result in sub-optimal device sizing or in failure to
appreciate focal stenoses
• Inappropriate patient selection may contribute to poor device performance
• Use of the Talent Converter is recommended in the following situations:
• with a length from the lowest renal artery to the proximal fabric edge of the previously placed
Talent or AneuRx bifurcated Stent Graft between 0 mm and 34 mm (including cases where a
bifur in conjunction with an aortic cuff are present)
• with a vessel diameter of >
• proximal aortic neck angulation ≤ 60° relative to the long axis of the aneurysm
• adequate sizing for both the pre-existing graft and the aortic neck is not possible due to
significant diameter differences between the pre-existing graft and the aortic neck (thus
excluding the use of an aortic cuff)
• inability to cannulate the contralateral gate of the bifur at the time of the index procedure
• pre-existing graft is unstable (for example, proximal aspect of the pre-existing graft is situated
within the aneurysm sac and an aortic cuff is not considered an appropriate fix)
• Use of the Talent Converter in combination with an iliac extension is recommended in cases where
the landing zone of the distal fixation site (within the Talent or AneuRx bifurcated graft segment) is
>16 mm in diameter
• Use of the Talent Converter without an iliac extension may be considered if the landing zone of the
distal fixation site (within the pre-existing Talent or AneuRx bifurcated Stent Graft leg) is ≤16 mm in
diameter and with at least 30 mm in overlap length (between the bifurcation and distal end of the
Talent Converter)
• Use of the Talent Converter with an iliac extension may be considered when the distal fixation site
within the iliac artery is greater than 15 mm in length and 8 mm to 22 mm in diameter
• Access vessel diameter and morphology (minimal tortuosity, occlusive disease and/or calcification)
should be compatible with vascular access techniques and delivery system profiles of 22 to 24
French. 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
• Prior to the procedure, pre-operative planning for access and placement should be performed. Key
anatomic elements that may prevent successful exclusion of the aneurysm include severe proximal
neck angulation (>60 degrees relative to the long axis of the aneurysm); short proximal aortic neck
(<10 mm); and circumferential thrombus and/or calcification 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. Proximal aortic sealing
18 mm and < 32 mm
zones exhibiting these key anatomic elements may be more conducive to graft migration and/or
endoleaks
• The Talent converter is not recommended in patients who:
• cannot tolerate contrast agents necessary for imaging
• will not be compliant with the necessary preoperative, intra-operative and post-operative
imaging and implantation studies as described in Section 12.0
• exceed weight and/or size limits which compromise or prevent the necessary imaging
requirements
• 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 endoleaks. Patients with uncorrectable coagulopathy may also
have an increased risk of Type II endoleak or bleeding complications
4.3 Implant Procedure
• Exercise care in handling and delivery technique to aid in the prevention of vessel rupture
• The danger of micro-embolization can increase with increased duration of the procedure
• The use of a Talent Converter with Xcelerant Hydro Delivery System (HDS) requires administration
of intravascular contrast. 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
• Renal complications may occur:
• From an excess use of contrast agents.
• As a result of embolic or misplaced stent graft. The radiopaque marker along the edge of the
stent graft should be aligned immediately below the lower-most renal arterial origin
• Systemic anticoagulation should be used during the implantation procedure based on hospital and
physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant should be
considered
• Minimize handling of the constrained endoprosthesis during preparation and insertion to decrease
the risk of endoprosthesis contamination and infection
• To activate the hydrophilic coating on the Xcelerant HDS, wipe the surface with a sterile gauze
soaked in saline solution. Always keep the graft cover hydrated for optimal performance.
• Maintain guide wire position during delivery system insertion
• Improper placement or fixation of the stent graft may cause an endoleak, migration or occlusion of
arteries (including the renals, internal iliacs), which may prevent blood flow necessary to organs and
extremities, necessitating surgical removal of the device. Renal artery patency must be maintained
to prevent/reduce the risk of renal failure and subsequent complications
• Unless medically indicated, do not deploy the Talent Converter in a location that will occlude
arteries necessary to supply blood flow to organs or extremities. Do not cover significant renal or
mesenteric arteries with the endoprosthesis. Vessel occlusion may occur
• Take care during manipulation of catheters, wires and sheaths within an aneurysm or pre-existing
stent graft. Significant disturbances may dislodge fragments of thrombus, which can cause distal
embolization
• Before deployment of the Converter, verify that the position of the guide wire extends sufficiently
above the aneurysmal area
• Care should be taken not to displace the pre-existing Talent or AneuRx Bifurcated Stent Grafts
during the placement and deployment of the Talent Converter
• Care should be taken not to damage or disturb the Converter Stent Graft position in the event that
further manipulations of the Converter are required (for example, balloon modeling)
• During general handling of the Xcelerant HDS, avoid bending or kinking the graft cover because it
may cause the Talent Converter Stent Graft to prematurely and improperly deploy
• Never advance or retract the Xcelerant HDS from the vasculature without the use of fluoroscopy
• Do not continue advancing any portion of the delivery system if resistance is felt during
advancement of the guide wire or delivery system. Stop and assess the cause of resistance.
Vessel or catheter damage may occur. Exercise particular care in areas of stenosis, intravascular
thrombosis or in calcified or tortuous vessels
• When aligning the position of the Xcelerant HDS so that the Talent Converter Stent Graft is in
proper position for deployment within the vessel, be sure that the fluoroscope is angled
perpendicularly to the center line of the infrarenal aorta to avoid parallax or other sources of
visualization error. Align the target area/fixation zone (for example, aortic neck) in the center of the
field. Some cranial-caudal angulation of the I-I tube may be necessary to achieve this, especially if
there is anterior angulation of the aneurysm neck
• Before initial deployment, it is suggested to position the Talent Converter Stent Graft slightly higher
than the targeted location
• Do not retract the graft cover before placing the delivery system in the proper anatomical position,
as this will initiate deployment of the stent graft. The Talent Converter Stent Graft cannot be
reconstrained or drawn back into the graft cover, even if the stent graft is only partially deployed. If
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