Medtronic VAMC2424C100TU Instructions for Use

Valiant

®

Thoracic Stent Graft with the Captivia® Delivery System

Instructions for Use

Trademarks may be registered and are the property of their respective owners.

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Explanation of symbols that may appear on product labeling

Refer to the device labeling to see which symbols apply to this product.

Consult instructions for use at: www.medtronic.com/manuals

Catalogue number

CAUTION: Federal (USA) law restricts this device for sale by or on order of a physician.

Contents: One Device

Do not reuse

Do not use if indicator turns black

Do not use if package is damaged

Manufactured In

Manufacturer

MR Conditional

Non-pyrogenic

Peel here

Serial number

Sterilized using irradiation

Store at room temperature in a dark, dry place

Use by

FreeFlo Straight (Proximal Component)

FreeFlo Tapered (Proximal Component)

Closed Web Straight (Distal Component)

Closed Web Tapered (Distal Component)

Distal Bare Spring Straight (Distal Component)

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Valiant

®

Thoracic Stent Graft with the Captivia® Delivery System

TABLE OF CONTENTS

1. Device Description ................................................................................................................................................................................................................... 4

2. Indications for Use ................................................................................................................................................................................................................... 5

3. Contraindications ..................................................................................................................................................................................................................... 6

4. Warnings and Precautions ....................................................................................................................................................................................................... 6

5. Adverse Events ........................................................................................................................................................................................................................ 7

6. Summary of Clinical Studies .................................................................................................................................................................................................... 8

7. Patient Selection and Treatment ............................................................................................................................................................................................ 62

8. Patient Counseling Information .............................................................................................................................................................................................. 63

9. How Supplied ......................................................................................................................................................................................................................... 63

10. Clinical Use Information ......................................................................................................................................................................................................... 63

11. Implant Instructions ................................................................................................................................................................................................................ 66

12. Troubleshooting Techniques .................................................................................................................................................................................................. 73

13. Follow-up Imaging Recommendations ................................................................................................................................................................................... 73

14. Additional Surveillance and Treatment ................................................................................................................................................................................... 74

15. Device Registration ................................................................................................................................................................................................................ 74

16. MRI Safety Information .......................................................................................................................................................................................................... 74

Instructions for Use English 3

1. Device Description

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FreeFlo Straight

(Proximal Component)

FreeFlo Tapered

(Proximal Component)

Distal Bare Spring

Straight (Distal Component)

Closed Web Straight

(Distal Component)

Closed Web Tapered

(Distal Component)

The Valiant® thoracic stent graft with the Captivia® delivery system is designed for the endovascular repair of lesions of 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 thoracic stent graft and the disposable Captivia delivery system. The stent graft is preloaded into
the delivery system, which 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.

1.1. Stent Graft

A single, primary stent graft may be used by itself if its size is sufficient to provide the desired coverage. Alternatively, it may be used in combination with additional stent graft sections
that increase the graft length either distally or proximally to the primary section.

All stent graft components are composed of a self-expanding, spring scaffold made from Nitinol wire sewn to a fabric graft with non-resorbable sutures. The metal scaffolding is
composed of a series of serpentine springs stacked in a tubular configuration. 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 healthy vessel. The appropriate device oversizing is incorporated into the sizing guidelines. Section 10.2
contains detailed sizing information for all stent graft components. Table 1 contains a summary of the stent graft materials.

Table 1. Stent Graft Materials

Component

Springs Nitinol wire (55% Nickel, balance Titanium with trace elements)
Support Spring Nitinol wire (55% Nickel, balance Titanium with trace elements)
Graft Fabric High-density woven mono-filament polyester
Sutures Braided polyester
Radiopaque Markers Platinum-Iridium wire

The Valiant thoracic stent graft with the Captivia delivery system does not contain natural rubber latex; however, during the manufacturing process, it may have incidental contact with
latex.

1.1.1. Stent Graft Configuration Options

Material

Figure 1. Stent Graft Configuration Components

1. Proximal End

2. Distal End

3. FreeFlo

4. Closed Web

5. Bare Spring

7. Figur8 Marker

8. Zer0 Marker

9. Diameter

10. Covered Length

11. Total Length

6. Mini Support Spring

Note: This and all other product graphics appearing in this manual are not drawn to scale. They are for graphical representation only, and may appear differently under fluoroscopy.
The Valiant thoracic stent graft is available in 5 configuration options: FreeFlo Straight (proximal component), FreeFlo Tapered (proximal component), Closed Web Straight (distal

component), Distal Bare Spring Straight (distal component), and Closed Web Tapered (distal component). Each consists of an 8-peak, fully covered stent and a mini support spring,
which prevents the stent graft from infolding during and after deployment.

FreeFlo Straight Configuration (Proximal Component)

This configuration includes a FreeFlo proximal end and a Closed Web distal end. At the proximal end, an 8-peak bare stent extends past the covered stent graft to provide additional
fixation while maintaining transvessel flow.

The FreeFlo Straight configuration stent grafts are available in diameters ranging from 22 mm to 46 mm and covered lengths of approximately 100 mm, 150 mm, and 200 mm. The
proximal-end and distal-end diameters of the FreeFlo Straight configuration are constant throughout the covered length of the device.

Caution: A FreeFlo end should never be placed inside the graft covered section of another stent graft.

FreeFlo Tapered Configuration (Proximal Component)

The FreeFlo Tapered configuration has a FreeFlo proximal-end configuration and a Closed Web distal-end configuration. The proximal end of the FreeFlo Tapered configuration is
4 mm larger in diameter than its distal end. The FreeFlo Tapered configurations are available in proximal diameters ranging from 26 mm to 46 mm and distal diameters ranging from
22 mm to 42 mm. The covered length is approximately 150 mm.

Closed Web Straight Configuration (Distal Component)

This configuration includes Closed Web proximal and distal ends.
The Closed Web Straight configuration stent grafts are available in diameters ranging from 22 mm to 46 mm and covered lengths of approximately 100 mm, 150 mm, and 200 mm.

The proximal and distal end diameters of the Closed Web Straight configuration are constant throughout the covered length of the device.

Caution: A Closed Web configuration should never be used as the most proximally implanted stent graft.
Caution: A Closed Web Straight configuration may be implanted as the primary section only when implanting multiple stent grafts in a nontortuous segment of the descending

thoracic aorta, using the distal-to-proximal implantation technique.

4 Instructions for Use English

Distal Bare Spring Straight Configuration (Distal Component)

This configuration includes a Closed Web proximal end and a Bare Spring distal end. At the distal end, an 8-peak bare stent extends past the covered stent graft to provide additional
fixation while allowing for transvessel flow.

The Distal Bare Spring Straight configuration stent grafts are available in diameters ranging from 22 mm to 46 mm and a covered length of approximately 100 mm. The proximal and
distal end diameters of the Distal Bare Spring Straight configuration are constant throughout the covered length of the device.

Caution: A Bare Spring end should never be placed inside the covered section of another stent graft.

Closed Web Tapered Configuration (Distal Component)

This configuration includes Closed Web proximal and distal ends.
The Closed Web Tapered configuration stent grafts are available in proximal end diameters ranging from 26 mm to 46 mm and distal end diameters ranging from 22 mm to 42 mm.

The covered length is approximately 150 mm. The proximal end of the Closed Web Tapered configuration is 4 mm larger in diameter than its distal end.

Caution: A Closed Web configuration should never be used as the most proximally implanted stent graft.
Caution: A Closed Web Tapered configuration may be implanted as the primary section only when implanting multiple stent grafts in a nontortuous segment of the descending

thoracic aorta, using the distal-to-proximal implantation technique.

1.2. Delivery System

Figure 2. Captivia Stent Graft Delivery Systems

1. Luer Connector

2. Sideport Extension

3. Screw Gear

4. Slider/Handle

5. Trigger

6. Front Grip

7. Strain Relief

8. Graft Cover/Introducer Sheath

The Captivia delivery system consists of a single-use, disposable catheter with an integrated handle to provide controlled deployment. It is available in an outer diameter of 22,
24, and 25 French and a working length of approximately 83 cm. The catheter assembly is flexible and exclusively compatible with a 0.035 in (0.89 mm) guidewire. There are 2 types
of Captivia delivery systems: the FreeFlo and Closed Web stent graft delivery systems. The FreeFlo system delivers the FreeFlo Straight and FreeFlo Tapered configurations. The
Closed Web system delivers the Closed Web Straight, Distal Bare Spring Straight, and Closed Web Tapered configuration stent grafts. The FreeFlo system features a tip capture
mechanism, which is not present in the Closed Web system.

The Captivia delivery system is a multilumen device. Each lumen serves one of the following distinct functions:

The inner member provides a lumen to allow the system to track over a 0.035 in (0.89 mm) guidewire.

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The tip capture tube (FreeFlo stent graft delivery system only) provides a lumen to actuate the tip capture mechanism.

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The flexible stent stop provides a lumen to aid in tracking the system through tortuous anatomy and maintains stent graft position during deployment.

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The graft cover with stainless steel braid provides a lumen to contain the stent graft during tracking and to release the stent graft during deployment.

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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 tapered tip and graft cover are
coated with a lubricious hydrophilic coating. Once activated with a sterile gauze saturated in saline, this coating will facilitate vessel access and tracking through anatomy. A distal
radiopaque marker indicates the graft cover edge under fluoroscopy. A hemostasis valve at the proximal end of the delivery system minimizes blood loss and leakage during the
procedure. The stent graft is deployed by rotating or retracting the integrated slider handle. When using the FreeFlo stent graft delivery system, the tip capture release handle at the
rear of the delivery system is unlocked and retracted to release the bare stent.

Note: The Reliant® stent graft balloon catheter (packaged separately) can be used to assist in stent graft implantation.
Note: Never use a balloon when treating a dissection.

9. Stent Stop

10. Tip Capture Mechanism

11. RO Marker Band

12. Tapered Tip

13. Back End Lock

14. Tip Capture Release Handle

15. Clamping Ring

2. Indications for Use

The Valiant thoracic stent graft with the Captivia delivery system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the
appropriate anatomy including:

Iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;

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Instructions for Use English 5

nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or

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20 mm to 44 mm (dissections); and
nonaneurysmal aortic proximal and distal neck lengths ≥20 mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥20 mm proximal to the primary entry

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tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.

3. Contraindications

The Valiant thoracic stent graft with the Captivia delivery system is contraindicated in the following patient populations:

patients who have a condition that threatens to infect the graft

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patients with known sensitivities or allergies to the device materials (Table 1)

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Also consider the information in Patient Selection (Section 4.2).

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 Valiant thoracic stent graft with the Captivia delivery system should only be used by physicians and medical personnel trained in vascular interventional techniques,

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including training in the use of this device. Specific training expectations are described in Physician Training Requirements (Section 10.1).
Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.

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Caution: Federal (USA) law restricts this device for sale by or on the order of a physician.

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If preoperative case planning measurements are not certain, an inventory of device lengths and diameters necessary to complete the procedure should be available to the

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physician.

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Use of the device outside the recommended anatomical sizing may result in serious device related events.

4.2. Patient Selection

The Valiant thoracic stent graft with the Captivia delivery system is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary

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preoperative and postoperative imaging and implantation procedures described in Section 10 through Section 13.
The Valiant thoracic stent graft with the Captivia delivery system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and

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postoperative follow-up imaging.
The use of this device requires administration of radiographic agents. Patients with pre-existing renal insufficiency may have an increased risk of postoperative renal failure.

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The Valiant thoracic stent graft with the Captivia delivery system is not recommended in patients exceeding weight or size limits necessary to meet imaging requirements.

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Inappropriate patient selection may result in poor performance.

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Prior to the procedure, preoperative planning for access and placement should be performed. See Recommended Device Sizing (Section 10.2). Key anatomic elements that

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may affect successful exclusion of the lesion include tortuosity, short landing zone(s) [<20 mm], and thrombus or calcium formation at the implantation sites. In the presence
of anatomical limitations, a longer landing zone and additional stent grafts may be required to obtain adequate sealing and fixation.

The Valiant thoracic stent graft with the Captivia delivery system is intended for use in aortic neck diameters in the range of 18 to 42 mm (TAA), or landing zones in the range

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of 18 to 44 mm (BTAI) or 20 to 44 mm (dissection) and in aortic proximal and distal neck lengths of ≥20 mm (TAA) or landing zones ≥20 mm proximal to the primary entry tear
(BTAI, dissection). The most proximal extent of the landing zone must not be dissected. Coverage of the LSA may be necessary to gain the needed landing zone.

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Ensure that the Valiant thoracic stent graft is placed in a landing zone without evidence of circumferential thrombus, intramural hematoma, dissection, ulceration, or
aneurysmal involvement. Failure to do so may result in inadequate exclusion or vessel damage, including perforation. 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.

Coverage of the left subclavian artery without revascularization may increase the risk of stroke.

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The safety and effectiveness of the Valiant thoracic stent graft with the Captivia delivery system has not been evaluated in the following patient situations or populations:

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The patient requires planned placement of the covered proximal end of the stent graft requires implant to occur in Zone 0 or Zone 1 (Figure 3).

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The patient’s access vessel, as determined by treating physician, precludes safe insertion of the delivery system.
Note: Iliac conduits may be used to ensure the safe insertion of the delivery system.

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The patient has a significant or circumferential aortic mural thrombus, which could compromise fixation and seal of the implanted stent graft.

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The patient has a TAA with a contained rupture.

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The patient has acute, uncomplicated Type B dissection.

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The patient has chronic Type B dissection.

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The patient has received a previous stent or stent graft or previous surgical repair in the descending thoracic aortic area.

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The patient has pseudoaneurysms resulting from previous graft placement.

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The patient will be undergoing a concomitant surgical or endovascular treatment of an infrarenal aortic aneurysm.

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The patient has connective tissue disease (for example, Marfan syndrome or medial degeneration).

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The patient has a history of bleeding diathesis or coagulopathy, or refuses blood transfusions.

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The patient has had a cerebrovascular accident (CVA) within 3 months of the procedure.

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The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pretreatment.

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The patient has active systemic infections.

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The patient has an aortic fistula.

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The patient has aortitis or an inflammatory aneurysm.

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The patient has a mycotic aneurysm.

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The patient is a pregnant female.

6 Instructions for Use English

Figure 3. Covered Stent Graft Placement Zones

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The patient is less than 18 years old.

The long-term safety and effectiveness of the Valiant thoracic stent graft with the Captivia delivery system has not been established. All patients should be advised that

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endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical
findings (for example, enlarging aneurysm [>5 mm], endoleak, migration, inadequate seal zone, or continued flow into the false lumen in the case of a dissection) should
receive enhanced follow-up. Specific follow-up guidelines are described in Follow-up Imaging Recommendations (Section 13).

Strict adherence to the Valiant thoracic stent graft with the Captivia delivery system sizing guidelines (Table 3 to Table 9) is expected when selecting the device size. The

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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.

Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aorta and/or

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endoleak. An increase in aneurysm size, false lumen size, or persistent endoleak may lead to rupture.

4.3. Implant Procedure

Wrinkling of stent graft material may promote thrombus formation. If this occurs, inflate a conformable balloon within the deployed stent graft lumen to reduce wrinkling of the

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material.
Note: Medtronic recommends the Reliant stent graft balloon catheter for use with the Valiant thoracic stent graft. Data is not available for remodeling the Valiant thoracic stent

graft with other balloon catheters.
Caution: Never use a balloon when treating a dissection.

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Use the Reliant stent graft balloon catheter according to the Instructions for Use (IFU) supplied with the product. Do not attempt to use the Reliant stent graft balloon
catheter before completely reading and understanding the IFU supplied with the product.

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Do not over-inflate the balloon.

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Care should be taken not to balloon outside of the Valiant thoracic stent graft. If the proximal and distal radiopaque markers of the Reliant stent graft balloon catheter are
not completely within the covered portion of the Valiant thoracic stent graft, there is an increased risk of vessel injury, rupture, or possible patient death.

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Care should be taken when inflating the balloon, especially with calcified, tortuous, stenotic, or otherwise diseased vessels. Inflate slowly. It is recommended that a
backup balloon be available.

A seal zone <20 mm 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-

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filled or severely angled vessel wall.
Manipulation of wires, balloons, catheters, or endografts in the thoracic aorta may lead to vascular trauma, including aortic dissection and embolization.

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Do not bend, kink, or otherwise alter the Captivia delivery system prior to implantation because it may cause deployment difficulties.

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Discontinue advancement of the guidewire or delivery system if resistance is felt. The cause of resistance must be assessed in order to avoid vessel or delivery catheter

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damage.
Wire fractures are more likely to occur in conditions with an excessively oversized endoprosthesis, flexion, kinking, or bending during cardiac or respiratory cycles. Wire

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fractures may have clinical consequences, such as endoleak, endoprosthesis migration, or adjacent tissue damage.
Oversize the aortic portion of the stent graft by 10 to 20%, as appropriate for the patient. For additional sizing information, see Recommended Device Sizing (Section 10.2).

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Caution: Oversizing of the stent graft to the vessel >10% may be unsafe in the presence of dissecting tissue or intramural hematoma.
Due to the increased risk of dislodging material during distal repositioning of the Valiant thoracic stent graft, it is not recommended to position the device higher in the aorta in

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the presence of excessive calcification or thrombus formation. See Positioning the Captivia Delivery System (Section 11.6).
Do not advance the Valiant thoracic stent graft with the Captivia delivery system when it is partially deployed and is apposed to the vessel wall.

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The proximal end of the covered Valiant thoracic stent graft should not be placed beyond the origin of the left common carotid artery (ie, Zone 0 or Zone 1) (Figure 3). FreeFlo

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and Bare Spring Straight ends should never be placed inside the fabric covered section of another stent graft. This may result in abrasion of the fabric by the bare spring and
result in graft material holes or broken sutures.

Ensure that the Valiant devices are placed in a landing zone without evidence of circumferential thrombus, intramural hematoma, dissection, ulceration, or aneurysmal

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involvement. Failure to do so may result in inadequate exclusion or vessel damage, including perforation. 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 acute dissections with multiple devices, it is recommended to deploy the proximal device first. Inadvertent pressurization of the false lumen may result in

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retrograde dissection.
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.

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Consider adjunctive procedures to restore blood flow to malperfused branch vessels. Additional procedures during treatment in the Medtronic Dissection Trial included, but

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were not limited to, peripheral stenting and surgical bypass (e.g., carotid subclavian, fem-fem).
Endoleak left untreated during the implantation procedure must be carefully monitored after the implantation procedure.

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Avoid occluding arterial branches that do not have collateral or protected perfusion to end organs or body structures. If the left subclavian artery (LSA) is to be covered, check

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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/landing zone for fixation and sealing, transposition, or bypass of the LSA should be considered.

Caution: Patients with a patent LIMA (left internal mammary artery)-LAD (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.

4.4. MRI Safety Information

Nonclinical testing has demonstrated that the Valiant thoracic stent graft is MR Conditional. It can be scanned safely in 1.5 T and 3.0 T MR systems only, with using only the specific
testing parameters (Section 13.5). Additional MRI safety information is found in Section 13.5.

5. Adverse Events

5.1. Potential Adverse Events

Adverse events or complications associated with the use of the Valiant thoracic stent graft with the Captivia delivery system that may occur or require intervention include, but are not
limited to:

Instructions for Use English 7

• Access failure

• Access site complications (eg, spasm, trauma, bleeding,
rupture, dissection)

• Adynamic Ileus

• Allergic reaction (to contrast, antiplatelet therapy, stent graft
material)

• Amputation

• Anesthetic complications

• Aortic expansion (e.g. aneurysm, false lumen)

• Aneurysm rupture

• Angina

• Aortic vessel rupture

• Arrhythmia

• Arterial stenosis

• Atelectasis

• Blindness

• Bowel ischemia/infarction

• Bowel necrosis

• Bowel obstruction

• Branch vessel occlusion

• Buttock claudication

• Cardiac tamponade

• Catheter breakage

• Cerebrovascular accident (CVA)/Stroke

• Change in mental status

• Coagulopathy

• Congestive heart failure

• Contrast toxicity

• Conversion to surgical repair

• 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

• Fistula (aortobronchia, aortoenteric, aortoesophogeal, arte­riovenous, 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

• Lymphocele

• Myocardial infarction

• 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

• Post-implant syndrome

• Post-procedural bleeding

• Procedural bleeding

• Prosthesis dilatation

• Prosthesis infection

• Prosthesis rupture

• Prosthesis thrombosis

• Pseudoaneurysm

• Pulmonary edema

• Pulmonary embolism

• Reaction to anaesthesia

• Renal failure

• Renal insufficiency

• Reoperation

• Respiratory depression or failure

• Retrograde Type A dissection

• Sepsis

• Seroma

• Shock

• Spinal neurological deficit

• Stent graft material failure (including breakage of
metal portion of device)

• Stent graft migration

• Stent graft misplacement

• Stent graft occlusion

• Stent graft twisting or kinking

• 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 thoracic stent graft with the Captivia delivery system should be immediately reported to Medtronic Vascular. To report an
incident in the US, call [phone].

6. Summary of Clinical Studies

The clinical evidence supporting the safety and effectiveness of the Valiant thoracic stent graft with the Captivia delivery system is from a combination of 5 clinical studies:

Study

Medtronic Dissection Trial to evaluate the Valiant thoracic stent graft with the Captivia delivery system in the treatment of acute, complicated Type B dissection
RESCUE US Clinical Study to evaluate the Valiant thoracic stent graft with the Captivia delivery system in the treatment of severe blunt thoracic aortic injuries/transection

Valiant Thoracic Stent Graft Clini­cal Study (VALOR II)

Valiant Captivia OUS Registry to provide confirmatory clinical information to support the engineering evaluation of the modified Captivia delivery system

Talent® Captivia Study

Subsequent to the enrollment in VALOR II, the delivery system was updated from the Xcelerant to the Captivia delivery system. The Captivia delivery system is a design iteration of
the Xcelerant delivery system. The primary difference between the 2 delivery systems is the incorporation of a tip capture mechanism designed to constrain the proximal bare springs
of the FreeFlo stent graft until proper positioning has been obtained.

6.1. Medtronic Dissection Trial

The Medtronic Dissection Trial was a prospective, non-randomized, multicenter, single-arm study. The primary objective was to evaluate the safety and effectiveness of the Valiant
thoracic stent graft in the treatment of acute, complicated Type B dissection, as determined by all-cause mortality within 30 days of the index procedure, compared to a performance
goal based on TEVAR and open surgical repair outcomes. A sample size of 50 subjects was planned to provide 80% power to establish a mortality rate lower than the performance
goal using a one-sided exact test at the 0.05 statistical significance level. An adaptive design was utilized such that additional subject enrollment (up to 84 subjects total) would be
allowed as necessary to meet the performance goal. However, the performance goal was met after evaluation of the primary endpoint for the initial 50 subjects.

Secondary observations included adverse events, technical success, secondary procedures, aortic remodeling, false lumen perfusion, and all-cause mortality within 12 months.
A total of 89 subjects were screened for enrollment in the study. The reasons for exclusion were lack of malperfusion or rupture (n=10), presence of chronic dissection >14 days

(n=7), inability to consent (n=3), no indication for intervention (n=3), inclusion criteria not met (n=2), fenestrated (n=2), intramural hematoma without dissection (n=2), <20 mm
proximal landing zone (n=2), unreliable for follow-up (n=1), patient refused (n=1), previous repair (n=1), medically managed (n=1), history of aortic repair (n=1), unstable for surgery
(n=1), Marfan's Syndrome (n=1), and retrograde extension to LCC (n=1).

Data was collected at the pre-treatment evaluation, during the procedure, post-operatively and at hospital discharge. After discharge, subjects were evaluated at one, six, and
12 months and are evaluated annually thereafter for five years post-implant.

A Clinical Events Committee met to review and adjudicate all deaths and unanticipated adverse device effects (UADEs) for relatedness to the aorta, device and procedure. No
UADEs were identified in the study. A Data Monitoring Committee (DMC) met to review safety data and monitor the overall conduct of the study. The DMC reviewed the 30-day data
for the first 20 subjects and for the first 30 subjects. The committee recommended that the trial continue without modifications. A central imaging core lab was utilized to provide
independent evaluation of imaging findings. Both site and core lab data are included in this report, as appropriate. The data cut off for this report was May 30, 2013.

6.1.1. Suitability of the Performance Goal

The expected 30-day mortality rate was 11%. The Performance Goal was set at 25% after considering the mortality rates from 1) the Society for Vascular Surgery (SVS) Master
Access File (MAF) of 85 acute, complicated dissection subjects; 2) the literature on open surgical repair and 3) the literature on TEVAR treated dissection patients. The performance
goal allowed for reasonable variances due to the low rate of occurrence, the low baseline sample size in the literature and MAF and for variances in outcomes due to both a potential
difference in patient complicating factors and a broader selection of physicians implanting the device in this study.

Objective

(BTAI) in the descending thoracic aorta
to demonstrate the safe and effective use of the Valiant thoracic stent graft for the treatment of fusiform aneurysms and saccular aneur-

ysms/penetrating ulcers of the descending thoracic aorta in subjects who were candidates for endovascular repair

to provide confirmatory clinical information to support the engineering evaluation of the modified Captivia delivery system

8 Instructions for Use English

6.1.2. Subject Accountability and Follow-up

Subject Follow -up

% (m/n)

2

Subject Imaging

% (m/n)

2

Subj ects with Adequate Imaging to Assess the Parameter

% (m/n)

2

Subject Events Occurring Before Next Visit

Implant

and

Follow-up

Eligible

1

Clinical

Follow -

up

Imaging

Follow -

up

CT/MR

Imaging

Chest

X- Ray

Additional

Imaging

Modalities

Max

DTA

Diameter

Change in

Max DTA

Diameter

from

Discharge

3

Endoleak

Migration

Integrity

Enrolled

but not

Implanted

Withdrawal

Conversion

to Surgery
Death

Lost to

Follow -

up

Not

Due

for

Next

Visit

Implant

50

Events

Between

Implant

and

Discharge

0

0

0
3

0

0

Discharge

47

97.9%

(46/47)

80.9%

(38/47)

76.6%
(36/47)

4

2.1% (1/47)

76.6%

(36/47)

68.1%

(32/47)

78.7%

(37/47)

Events

Between

Discharge

and

1-Month

0

0
1

0

0

1-Month

46

97.8%

(45/46)

97.8%

(45/46)

97.8%

(45/46)

91.3%

(42/46)

0.0% (0/46)

95.7%

(44/46)

87.0%

(40/46)

97.8%

(45/46)

95.7%

(44/46)

Events

Between

1-Month

and

6-Month

1

0
3

1

0

6-Month

41

87.8%

(36/41)

82.9%

(34/41)

80.5%

(33/41)

68.3%

(28/41)

0.0% (0/41)

80.5%

(33/41)

80.5%

(33/41)

78.0%

(32/41)

78.0%

(32/41)

78.0%

(32/41)

Events

Between

6-Month

and

12-Month

0

0
1

0

0

12-Month

40

90.0%

(36/40)

85.0%

(34/40)

85.0%

(34/40)

75.0%

(30/40)

0.0% (0/40)

85.0%

(34/40)

85.0%

(34/40)

85.0%

(34/40)

85.0%

(34/40)

85.0%

(34/40)

0

1

0
8

1
0

Total Deaths

Deaths Post Conversion to Surgery

Total

8

1

Eligible at implant are all subjects enrolled by snapshot date. Eligible (ET) for time intervals post implant is eligible from the previous interval (EPI) less the sum of enrolled but not implanted (ENI) plus withdrawal (W) plus

conversion to surgery (CTS) plus death (D) plus lost to follow up (LTF) plus not due for next visit (NDNV) subjects. ET = EPI – (ENI + W + CTS + D + LTF + NDNV)

2

Percentages for eligible subjects are based on number of all subjects enrolled by snapshot date and for clinical and site reported imaging follow-up are based on number of subjects who had follow-up visit within window divided

by number of eligible subjects. Within window visits are defined as: for discharge: day 0 to the day of discharge, for 1 month: 16-44 days, for 6 months: 123-243 days, for 12 months: 275-455 days.

3

The first post-implant image will be used as the baseline image for measuring the change in DTA diameter and migration.

4

36 subjects had CTs and 2 subjects had X-ray imaging only. X-ray imaging was not required at pre-discharge and thus these two patients do not show up under the X-ray column.

m = number of subjects in category, n = number of subjects with available values

Fifty subjects (50) were enrolled in this study between June 2010 and May 2012, at 16 investigational sites. All enrolled subjects underwent endovascular repair with the Valiant
thoracic stent graft. Figure 4 summarizes the subject accountability and compliance by study interval.

Figure 4. Subject Follow up, Imaging and Accountability

6.1.3. Subject Population Demographics and Baseline Parameters

Figure 5 through Figure 8 provide baseline parameters of the study subjects including demographics, medical history, clinical symptoms, and initial dissection assessment via imaging
at presentation.

Instructions for Use English 9

Subject Demographic

Age (years)

n

Mean ± SD

Median

Min, Max

Sex % (m/n)

Male

Female

Hispanic or Latino

Not Hispanic or Latino

Not Available

Refuses to answer

Race % (m/n)

Caucasian

African American

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaskan Native

Other

Not Available

Medtronic Dissection Trial

Subjects1

50

57.2 ± 12.9

56.5

18, 83

80.0% (40/50)

20.0% (10/50)

10.0% (5/50)

88.0% (44/50)

2.0% (1/50)

0.0% (0/50)

62.0% (31/50)

22.0% (11/50)

12.0% (6/50)

0.0% (0/50)

0.0% (0/50)

4.0% (2/50)

0.0% (0/50)

SVS MAF

Subjects

85

58.3 ± 15.4

59.0

25, 88

72.9% (62/85)

27.1% (23/85)

14.3% (12/84)

85.7% (72/84)

0.0% (0/84)

NA

52.9% (45/85)

27.1% (23/85)

3.5% (3/85)

1.2% (1/85)

1.2% (1/85)

0.0% (0/85)

14.1% (12/85)

Ethnicity % (m/n)

1

Based on number of ITT subjects with available data. ITT subjects are all enrolled subjects.

m = number of subjects in category, n = number of subjects with available values

Figure 5. Subject Demographics

Figure 6 summarizes the medical history of the subjects with available data. Among the subjects in the Medtronic Dissection Trial, conditions that are common to cardiovascular
disease were represented, specifically hypertension (90.0%), current tobacco use (43.8%), hyperlipidemia (32.7%), peripheral vascular disease(14.0%), coronary artery disease
(12.0%), abdominal aortic aneurysm (12.0%) and ascending thoracic aneurysm (8.0%). Similarly, the SVS MAF subjects had a high incidence of hypertension (83.5%) and current
tobacco use (32.5%). Information on other categories was unavailable.

Among the SVS MAF subjects, 11.8% had vascular disorders as compared to 44% in the Medtronic Dissection Trial group and 7.1% had GU/Renal disorders as compared to 38% in
the Dissection Trial group.

10 Instructions for Use English

Congestive Heart Failure

Hypertension

MI

Arrhythmia

Angina

Coronary Artery Disease

Coronary Artery Bypass Grafting (CABG)

Percutaneous Coronary Intervention

Other Cardiac

Vascular

Abdominal Aortic Aneurysm

Ascending Thoracic Aneurysm

Family History of Aneurysms

Peripheral Vascular Disease

Carotid Artery Disease

Lower Extremity Claudication

Lower Extremity Rest Pain

Lower Extremity Ulcers

DVT

Pulmonary Embolus

Other Vascular

Pulmonary

COPD

Mechanical Ventilation (for > 24 hrs)

Other Chronic Pulmonary Disease

Cerebrovascular/Neurological

Transient Ischemic Attack (TIA)

Stroke/Cerebrovascular Accident (CVA)

Paraplegia

Paraparesis

Other Cerebrovascular/Neurological

GU/Renal

Hemodialysis

Chronic Renal Failure

Renal Insufficiency

Other GU/Renal

Connective Tissue Disease

Marfan Syndrome

Ehlers Danlos

Other Connective Tissue Disease

Diabetes Mellitus

Insulin Dependent

Cancer

Liver Disease

GI Conditions

Bleeding Disorder

Hyperlipidemia

Other Systemic Conditions

History of Alcohol Abuse

Tobacco Use

Current Smoker

Former Smoker

Never Smoked

Other Medical History

1

Based on number of ITT subjects with available data
Not all subjects answered every medical history question and that is reflected in the denominator for each category. In cases where the data was missing, the
sites were queried and the data was unavailable.
m = number of subjects in category, n = number of subjects with available values. A subject may have more than one condition; hence, number of subjects at
higher level may not be equal to the total at lower level.

2

Fisher's exact test

Subject Medical History

SVS MAF

Subjects

% (m/n)

89.4% (76/85)

10.6% (9/85)

83.5% (71/85)

11.8% (10/85)

11.8% (10/85)

NA

NA

NA

NA

NA

11.8% (10/85)

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

12.9% (11/85)

10.6% (9/85)

NA

2.4% (2/85)

7.1% (6/85)

0.0% (0/85)

3.5% (3/85)

2.4% (2/85)

1.2% (1/85)

0.0% (0/85)

7.1% (6/85)

NA

NA

NA

NA

4.7% (4/85)

NA

NA

NA

12.9% (11/85)

NA

0.0% (0/85)

NA

NA

NA

NA

NA

32.5% (27/83)

37.3% (31/83)

30.1% (25/83)

NA

Medtronic Dissection Trial

Subjects
% (m/n)1

90.0% (45/50)

8.0% (4/50)

90.0% (45/50)

6.0% (3/50)

8.0% (4/50)

14.0% (7/50)

12.0% (6/50)

2.0% (1/50)

4.0% (2/50)

4.0% (2/50)

44.0% (22/50)

12.0% (6/50)

8.0% (4/50)

4.3% (2/47)

14.0% (7/50)

4.1% (2/49)

6.1% (3/49)

6.0% (3/50)

4.0% (2/50)

6.0% (3/50)

0.0% (0/50)

14.0% (7/50)

18.0% (9/50)

4.0% (2/50)

6.0% (3/50)

12.0% (6/50)

8.0% (4/50)

0.0% (0/50)

0.0% (0/50)

2.0% (1/50)

2.0% (1/50)

38.0% (19/50)

2.0% (1/50)

0.0% (0/50)

16.0% (8/50)

0.0% (0/50)

8.0% (4/50)

2.0% (1/50)

14.0% (7/50)

0.0% (0/50)

22.4% (11/49)

32.7% (16/49)

4.1% (2/49)

4.0% (2/50)

43.8% (21/48)

35.4% (17/48)

20.8% (10/48)

40.0% (20/50)

4.0% (2/50)

24.0% (12/50)

Cardiac

0.0% (0/50)

0.0% (0/50)

0.0% (0/50)

0.0% (0/49)

9.4% (8/85)

p-value

2

>0.999

0.767

0.443

0.371

0.571

NA

NA

NA

NA

NA

<0.001

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

0.458

0.212

NA

0.051

>0.999

NA

0.530

>0.999

0.370

<0.001

NA

NA

NA

0.296

0.572

NA

0.412

NA

NA

NA

NA

NA

NA

>0.999

NA

NA

NA

NA

NA

0.355

Figure 6. Subject Medical History

Instructions for Use English 11

Clinical symptoms reported at onset/presentation are summarized in Figure 7. The most common symptoms for the Medtronic Dissection Trial subjects were back/chest pain (88.0%),
hypertension (52.0%), abdominal pain (36.0%), nausea/vomiting (24.0%) and paraparesis (12.0%). The most common symptoms for the SVS MAF subjects at onset were pain
(76.5%), hypertension (43.5%) and bleeding (8.2%).

Of the 50 subjects enrolled in the study, 40 (80%) experienced malperfusion with no rupture, 7 (14%) experienced rupture with no malperfusion and 3 (6%) experienced both
malperfusion and rupture.

12 Instructions for Use English

Rupture % (m/n)

Malperfusion % (m/n)

Visceral Ischemia % (m/n)

Renal Ischemia % (m/n)

Lower Limb Ischemia % (m/n)

Spinal Cord Ischemia % (m/n)

At Onset

Duration from Onset to Presentation (days)

n

Median

Min, Max

Duration from Onset to Procedure (days)

n

Mean ± SD

Median

Min, Max

Hypertension % (m/n)

Pain % (m/n)

Abdominal Pain % (m/n)

Back/Chest Pain % (m/n)

Bleeding % (m/n)

Paraplegia % (m/n)

Paraparesis % (m/n)

Headache % (m/n)

Syncope/Altered Consciousness % (m/n)

Nausea/Vomiting % (m/n)

At Presentation

Duration from Presentation to Procedure (days)

n

Mean ± SD

Median

Min, Max

Hypertension % (m/n)

Pain % (m/n)

Abdominal Pain % (m/n)

Back/Chest Pain % (m/n)

Bleeding % (m/n)

Paraplegia % (m/n)

Paraparesis % (m/n)

Headache % (m/n)

Syncope/Altered Consciousness % (m/n)

Nausea/Vomiting % (m/n)

New Medications After Admission

Inotropic Support % (m/n)

Anti-Hypertensives % (m/n)

1

Based on number of ITT subjects with available data
m = number of subjects in category, n = number of subjects with available values

2

A t-test was performed on duration measures; Fisher's exact test was carried out on other parameters.

Medtronic Dissection Trial

Subjects1

20.0% (10/50)

86.0% (43/50)

40.0% (20/50)

42.0% (21/50)

40.0% (20/50)

6.0% (3/50)

2.0% (1/50)

50

1.4 ± 2.4

0.0

0, 10

50

4.7 ± 4.5

3.0

0, 23

52.0% (26/50)

94.0% (47/50)

36.0% (18/50)

88.0% (44/50)

2.0% (1/50)

4.0% (2/50)

12.0% (6/50)

4.0% (2/50)

0.0% (0/50)

24.0% (12/50)

50

3.3 ± 3.6

1.5

0, 14

60.0% (30/50)

92.0% (46/50)

42.0% (21/50)

78.0% (39/50)

2.0% (1/50)

4.0% (2/50)

14.0% (7/50)

4.0% (2/50)

2.0% (1/50)

18.0% (9/50)

16.0% (8/50)

84.0% (42/50)

SVS MAF

Subjects

31.8% (27/85)

71.8% (61/85)

14.1% (12/85)

25.9% (22/85)

40.0% (34/85)

2.4% (2/85)

5.9% (5/85)

NA

NA

NA

NA

85

2.9 ± 3.4

1.0

0, 14

43.5% (37/85)

76.5% (65/85)

NA

NA

8.2% (7/85)

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Ischemia (Other) % (m/n)

Mean ± SD

p-value

2

>0.999

0.165

0.089

0.001

0.058

0.359

0.412

NA

0.015

0.375

0.009

NA

NA

0.257

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Figure 7. Clinical Symptoms

Instructions for Use English 13

1

Based on number of ITT subjects with available data

m = number of subjects in category
n = number of subjects with available data

28.6% (14/49)

90.0% (45/50)

6.0% (3/50)

4.0% (2/50)

48.0% (24/50)

10.0% (5/50)

14.0% (7/50)

8.0% (4/50)

14.0% (7/50)

6.0% (3/50)

74.0% (37/50)

22.0% (11/50)

4.0% (2/50)

6.1% (3/49)

2.0% (1/49)

0.0% (0/49)

0.0% (0/49)

20.4% (10/49)

6.1% (3/49)

4.1% (2/49)

20.4% (10/49)

12.2% (6/49)

% (m/n)

1

Initial Dissection Assessment

Site of Proximal Entry Tear

Proximal Descending Aorta

Mid Descending Aorta

Distal Descending Aorta

Visible Re-entry Tears

None

One Tear

Two Tears

Three Tears

Four Tears

Five Tears

Most Proximal Aspect of Dissection

At LSA

Greater Than 2 cm Distal to LSA

Mid Descending Aorta

Most Distal Aspect of Dissection

Thoracic Aorta

Celiac Trunk

Superior Mesenteric Artery

Abdominal Aorta (Suprarenal)

Abdominal Aorta (Infrarenal)

Aortic Bifurcation

Common Iliac

Internal Iliac

External Iliac

Femoral Artery

ASA Physical
Classification

I

1

Based on number of ITT subjects with available data

m = number of subjects in category,
n = number of subjects with available values

II

III

IV

V

Not assessed

SVS MAF

Subjects

% (m/n)

22.4% (19/85)

0.0% (0/85)

2.4% (2/85)

64.7% (55/85)

10.6% (9/85)

Dissection

Subjects
% (m/n)

1

0.0% (0/50)

6.0% (3/50)

22.0% (11/50)

66.0% (33/50)

6.0% (3/50)

0.0% (0/85) 0.0% (0/50)

14 Instructions for Use English

Figure 8. Initial Dissection Assessment

Figure 9. ASA Physical Classification

Thoracic Aortic Measurements: Diameters (mm)

1

AD1: Maximum Thoracic Aortic Centerline Diameter

N

Mean ± SD

Median

Min, Max

AD2: Maximum True Lumen Diameter at AD1

N

Mean ± SD

Median

Min, Max

AD3: Maximum False Lumen Diameter at AD1

N

Mean ± SD

Median

Min, Max

D1: Diameter of Distal Margin of LCCA (Long Axis of Ellipse)

N

Mean ± SD

Median

Min, Max

Diameter at Proximal Landing Zone if Different from D1

N

Mean ± SD

Median

Min, Max

Right External Iliac Artery Diameter

N

Mean ± SD

Median

Min, Max

Left External Iliac Artery Diameter

N

Mean ± SD

Median

Min, Max

Site

Reported

50

40.6 ± 7.5

40.0

18, 60

50

19.9 ± 9.9

20.0

3, 52

50

23.0 ± 8.9

23.5

0, 40

50

32.0 ± 4.3

32.0

20, 44

50

31.4 ± 3.1

31.0

22, 38

49

10.2 ± 2.6

10.0

5, 18

49

10.0 ± 3.0

10.0

0, 18

1

Based on number of ITT subjects with available data

Figure 10. Aortic and Iliac Measurements at Presentation: Diameters

Instructions for Use English 15

Thoracic Aortic Measurements: Lengths (mm)

1

L1: Landing Zone (Distal Margin of LCCA to Primary Entry Tear)

N

Mean ± SD

Median

Min, Max

L2: Total Length of Aortic Dissection (Thoracic and Abdominal)

N

Mean ± SD

Median

Min, Max

L3: Total Thoracic Aortic Length (LCCA to Celiac)

N

Mean ± SD

Median

Min, Max

Site

Reported

50

39.7 ± 34.0

29.5

20, 223

46

376.4 ± 111.4

378.0

50, 580

47

278.4 ± 63.6

271.0

190, 580

1

Based on number of ITT subjects with available data

Figure 11. Aortic Measurements at Presentation: Lengths

Number of Devices Implanted

Subjects
% (m/n)

1

1

62.0% (31/50)

2

32.0% (16/50)

3

6.0% (3/50)

1

Based on number of implanted subjects with available data

m = number of subjects in category, n = number of subjects with available values

Device Diameter (mm)

1

Number of Devices Implanted (n)

22 0

24 0

26 1

28 0

30 1

32 13

34 13

36 7

38 10

40 4

42 1

44 0

46 0

1

Based on number of implanted subjects with available data

6.1.4. Valiant Thoracic Stent Graft Usage

All subjects successfully received one (1) or more devices. There were no device malfunctions reported. Thirty-one of the 50 subjects enrolled received a single device. Sixteen of the
remaining subjects received two (2) stent grafts and three (3) subjects received three (3) stent grafts at the initial procedure.

Figure 12 below contains the information regarding the average number of devices implanted per subject at initial procedure. Figure 13 provides further information on number of
devices implanted to treat the subjects in this study population. A distribution of the type of device components of the Valiant thoracic stent graft configuration implanted is shown
in Figure 14 and Figure 15 lists the Core Lab reported length of coverage at baseline.

Figure 12. Number of Devices Implanted at Initial Procedure

16 Instructions for Use English

Figure 13. Proximal Diameters of Implanted Proximal Devices at Initial Procedure

Device Type

% (m/n)1

FreeFlo Straight (Proximal Component) 75.0% (54/72)

Closed Web Straight (Distal Component) 9.7% (7/72)

Distal Bare Spring Straight (Distal Component) 0.0% (0/72)

Closed Web Tapered (Distal Component) 15.3% (11/72)

1

Based on total number of devices implanted in all subjects

m = number of devices in category, n = total number of devices implanted in all subjects

Figure 14. Devices Implanted by Type at Initial Procedure

Length of Coverage at Baseline

1, 2

(mm)

n 47

Mean ± SD 196.9 ± 67.1

Median 170.9

Min, Max 93, 346

1

Baseline image is the first post-procedure image.

2

Based on number of implanted subjects with available data

Core Lab Reported Table

Technical Success

1

% (m/n)

Vessel Access Success 100.0% (50/50)

Delivery Success 100.0% (50/50)

Deployment Success 100.0% (50/50)

1

Based on number of ITT subjects with available data

m = number of subjects in category, n = number of subjects with available values

% (m/n)1

Proximal Entry Tear Covered 100.0% (50/50)

1

Based on number of ITT subjects with available data

m = number of subjects with successful events, n = number of subjects with available values

Entry Tear Coverage

Figure 15. Core Lab Reported Length of Coverage at Baseline

6.1.5. Acute Procedural Data

The technical success was 100%. Vessel access was obtained, the device was successfully delivered and deployed and the proximal entry tear was successfully covered in all
subjects, as shown in Figure 16 and Figure 17.

Figure 16. Technical Success

Figure 17. Entry Tear Coverage at Implant

Acute measures at implant are summarized in Figure 18 and Figure 19.

Instructions for Use English 17

18.0% (9/50)

Implant Procedure

% (m/n)

Heparin Administered During Implant

98.0% (49/50)

Type of Anesthesia Used

General

100.0% (50/50)

Spinal

4.0% (2/50)

Epidural

Local

None

40.0% (20/50)

Partial

16.0% (8/50)

Complete

44.0% (22/50)

Subjects with LSA Coverage

LSA Covered Subjects with Any Pre-implant Adjunctive

Procedure

1

10.0% (3/30)

LSA Covered Subjects with Any Post-implant Adjunctive
Procedure

2

23.3% (7/30)

1

These included carotid to subclavian bypass, left renal stent, left iliac stent, right iliac stent.

m = number of subjects in category, n = number of subjects with available data.
For Subjects with LSA Coverage, the denominator is based on those with LSA coverage or
partial coverage.

2

These included carotid to subclavian bypass, fem fem bypass, SMA stent, left iliac stent, right

iliac stent and other.

0.0% (0/50)

0.0% (0/50)

Spinal Protective Measure

LSA Coverage

Spinal CSF Drain

Maintenance of controlled hypertension following placement

Monitoring of evoked potentials

6.0% (3/50)

32.0% (16/50)

54.0% (27/50)

Figure 18. Implant Procedure

18 Instructions for Use English

Acute Measurements at Implant

1

Duration of Implant Procedure (min)

n

50

Mean ± SD

142.9 ± 125.6

Median

108.5

Min, Max

45, 920

Contrast Volume (ml)

n

47

Mean ± SD

122.2 ± 72.1

Median

115.0

Min, Max

20, 300

Total Fluoroscopic Time (min)

n

42

Mean ± SD

17.1 ± 25.7

Median

12.2

Min, Max

4, 175

Blood Loss During Procedure (ml)

n

49

Mean ± SD

180.1 ± 223.6

Median

100.0

Min, Max

10, 1400

Subjects Requiring Blood Transfusion % (m/n)

40.0% (20/50)

Time in ICU (hours)

n

49

Mean ± SD

211.4 ± 429.2

Median

76.0

Min, Max

5, 2737

Overall Hospital Stay (days)

n

50

Mean ± SD

14.1 ± 19.9

Median

9.0

Min, Max

1, 124

1

Based on number of ITT subjects with available data

m = number of subjects in category, n = number of subjects with available values

Figure 19. Acute Measurements at Implant

Figure 20 lists the 7 (seven) adjunctive procedures performed prior to and twenty three (23) adjunctive procedures performed after deployment of the study device. Three (3) subjects
had an LSA-Carotid bypass procedure before the implant and one (1) subject underwent the bypass as an adjunctive procedure after the implant.

Instructions for Use English 19

Adjunctive Procedures Performed

Prior to

Deployment

% (m/n)

1

After Deployment

% (m/n)

2

1

Based on number of ITT subjects with available data

2

Based on number of implanted subjects with available data

m = number of subjects in category, n = number of subjects with available data

3

Thoracentesis/and endoscopy; thrombectomy left common/external IA, interposition graft L CFA;

laparotomy; right common femoral exposure, false lumen thrombectomy and obliteration, patch
angioplasty with bovi; endovascular repair of abdominal aortic dissection; right external iliac
thrombectomy and stenting and fasciotomy of the right calf; right axilla-femoral bypass and right
sided calf fasciotomy

4

Some subjects had multiple adjunctive procedures.

Intervention location: Aortic arch

Carotid to Subclavian Bypass

Intervention location: Mesenteric vessels

SMA Stent

Intervention location: Renal vessels

Left Renal Stent

Intervention location: Iliac vessels

Left Iliac Stent

Intervention location: Femoral vessels

Fem-Fem Bypass

Right Iliac Stent

Right Renal Stent

Other

3

No. of Subjects with Adjunctive Procedures

4

0.0% (0/50)

2.0% (1/50)

6.0% (3/50)

6.0% (3/50)

2.0% (1/50)

4.0% (2/50)

0.0% (0/50)

0.0% (0/50)

4.0% (2/50)

2.0% (1/50)

0.0% (0/50)

0.0% (0/50)

6.0% (3/50)

0.0% (0/50)

2.0% (1/50)

2.0% (1/50)

2.0% (1/50)

2.0% (1/50)

2.0% (1/50)

0.0% (0/50)

2.0% (1/50)

16.0% (8/50)

12.0% (6/50)

8.0% (4/50)

6.0% (3/50)

6.0% (3/50)

14.0% (7/50)

28.0% (14/50)

Figure 20. Adjunctive Procedures Performed

% (m/n) [95% UCL]

1, 2, 3

30-day All-Cause Mortality 8.0% (4/50) [17.4%]

1

95% Upper Confidence Limit (UCL) was calculated using an exact method

based on the binomial distribution.

2

Based on the number of evaluable subjects. Subjects will be considered

unevaluable if they are withdrawn before the lower limit of the 30-day
follow-up window (16 days) or they are lost to follow-up before the lower
limit of the 30-day follow-up window (16 days) and had no contact thereafter.

3

Based on CEC adjudicated data

Primary Endpoint

6.1.6. Safety and Effectiveness Results

6.1.6.1. Primary Endpoint Analysis

The primary endpoint for this trial was the all-cause mortality within 30 days of the index procedure. The Medtronic Dissection Trial met its primary endpoint with a 30-day all-cause
mortality rate of 8.0%. The upper limit of the one-sided 95.0% confidence interval on the 30-day mortality rate was 17.4%, which was less than the performance goal of 25.0%.
Four (4) subjects died within 30 days of the index procedure. Figure 21 lists the site and CEC adjudications for these deaths.

All-cause mortality within 30 Days for subjects with the complicating factor of rupture was 0.0% (0 out of 10 subjects). All-cause mortality within 30 days for subjects with the
complicating factor of ischemia only was 10% (4 out of 40 subjects).

20 Instructions for Use English

Figure 21. Primary Endpoint—All-Cause Mortality within 30 Days

Implant to

Death (days)

Cause of Death
Site Reported

Death Relatedness

1

Site Reported

Death Relatedness

1

CEC Adjudicated

0 Cardiac Tamponade Procedure Related Device Related2,

Procedure Related,
Dissection Related

1 Mesenteric Ischemia In

Totalis

Dissection Related Dissection Related

9 Sepsis Not Related Procedure Related,

Dissection Related

26 Pulmonary Embolism Not Related Procedure Related,

Dissection Related

1

Relationship to Device/Procedure/Dissection

2

The subject had a large pericardial effusion with acute cardiac tamponade. Underlying

causes/conditions were listed as cardiac arrest, ascending aortic dissection and ascending aortic
aneurysm
Site and CEC Adjudicated Reported Table

Figure 22. Listing of Deaths

6.1.6.2. Secondary Observations

Figure 23 summarizes the secondary observations in the Medtronic Dissection Trial.

Instructions for Use English 21

1

Based on number of ITT subjects with available data

2

Based on the number of evaluable subjects. Subjects will be considered unevaluable if they are withdrawn before the
lower limit of the 12 months follow-up window (275 days) or they are lost to follow-up before the lower limit of the 12
months follow-up window (275 days) and had no contact thereafter.

3

Additional endovascular device placed

4

LSA plug

5

Based on CEC adjudicated data

6

Based on the number of subjects with evaluable imaging at follow-up visit
Site Reported and Core Lab Reported Table

100.0% (50/50)

Successful Delivery and Deployment of the Stent Graft

1

Coverage of Proximal Entry Tear at Implant1

Adverse Events within 30 Days

1

Non-serious Adverse Events

Device related

Procedure related

Serious Adverse Events

Device related

Dissection related

Procedure related

Dissection related

Rupture within 30 Days

1

Secondary Procedures within 12 Months

2

Secondary Endovascular Procedures related to the Dissection

3

Secondary Endovascular Procedures not related to the Dissection

4

Open Repair of Retrograde Type A Dissection

Conversion to Open Repair for Descending Dissection

LSA Bypass

Adverse Events within 12 Months

2

Non-serious Adverse Events

Device related

Procedure related

Serious Adverse Events

Device related

Dissection related

Procedure related

Dissection related

Rupture within 12 Months

2

All-Cause Mortality within 12 Months

2,5

Continuing or New False Lumen (FL) Perfusion at 6 Month Visit

6

Core Lab Reported

Continuing or New False Lumen (FL) Perfusion at 12 Month Visit

4

Core Lab Reported

100.0% (50/50)

16.0% (8/50)

52.0% (26/50)

16.0% (8/50)

0.0% (0/50)

38.0% (19/50)

4.0% (2/50)

20.0% (10/50)

4.0% (2/50)

0.0% (0/50)

28.0% (14/50)

6.3% (3/48)

4.2% (2/48)

2.1% (1/48)

4.2% (2/48)

0.0% (0/48)

16.7% (8/48)

59.2% (29/49)

16.7% (8/48)

0.0% (0/48)

46.9% (23/49)

4.2% (2/48)

20.8% (10/48)

6.3% (3/48)

0.0% (0/48)

34.7% (17/49)

14.6% (7/48)

39.4% (13/33)

27.3% (9/33)

% (m/n)

6.1.6.3. Safety Results: Summary of Adverse Events

Only those adverse events and serious adverse events that were related to the device, to the implant procedure and/or to the aortic disease and serious adverse events that led to
death, regardless if they were related to the device, procedure or the aortic disease, were reported by the sites. Thirty eight percent of eligible subjects experienced an SAE within
30 days and 19.6% experienced an SAE between 31 and 365 days. Sixteen percent of eligible subjects experienced an AE (excluding SAEs) within 30 days and 2.2% experienced
an AE (excluding SAEs) between 31 and 365 days. Figure 25 through Figure 27 list all adverse events and their relationship to the device, the procedure or the disease, by date of
onset. Deaths are listed in Figure 28.

A subject may have experienced multiple adverse events, and in different subcategories; therefore, the number of subjects in each category may not be the sum of those in each
subcategory. Each subject was only counted once in each subcategory. An adverse event may have been reported as related to one or more of the following: device, dissection or
procedure. In cases where the AE was reported to be related to more than one category, it was included in all applicable AE tables. Therefore, the same event may appear in the
device-related, procedure-related or dissection-related SAE tables.

A summary of selected 30-Day SAE results from the Medtronic Dissection Trial and the SVS MAF group is provided in Figure 24.

22 Instructions for Use English

Figure 23. Secondary Observations