Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections
Conditions: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Sponsor: Medtronic Cardiovascular

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 101 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
18. OTHER RECORDS AND REPORTS 
No additional records and/or reports, other than those previously described in this 
investigational plan or required for subpart G of 21 CFR 812, will be maintained for this 
clinical investigation. 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 102 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDICES 
A. 
Instructions for Use  
B. 
Major Adverse Event Definitions 
C. 
Adverse Event Definitions 
D. 
Device-Related Adverse Event Definitions 
E. 
Informed Consent Templates 
F. 
Labeling 
G. 
Assessments and Guidelines 
H. 
Explant and Returned Product Instructions 
I. 
CMS Study Criteria 
J. 
Table of Changes – CIP VERSION 1A to 1B 
K. 
Table of Changes - CIP VERSION 1B to 1C 
L. 
Table of Changes - CIP VERSION 1C to 1D 
M. 
Table of Changes – CIP VERSION 1D to 1E 
N. 
Table of Changes – CIP VERSION 1E to 1F 
 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 103 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX A – INSTRUCTIONS FOR USE 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 104 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX B –DEFINITIONS 
MAJOR ADVERSE EVENT DEFINTIONS 
All-Cause Mortality: 
Death from any cause. 
Myocardial Infarction (MI): 
Myocardial necrosis as evidenced by ≥ 2 of 
the following 3 findings:  
1. new clinical symptoms 
suggesting MI 
2. changes on ECG consistent 
with MI 
3. elevated CK > 2 times the 
upper limit of normal (per the 
institution). 
Paraplegia: 
Complete loss of motor and/or sensory 
function in the lower extremities and lower 
portions of the trunk due to spinal cord injury 
or disease and occurring intra- or 
postoperatively and persisting > 1 month. 
Renal Failure: 
Failure of renal function requiring dialysis or 
elevation of serum creatinine ≥ 2 times the 
baseline value. 
Cerebrovascular Accident 
(CVA)/Stroke: 
Cerebrovascular ischemia or hemorrhage 
causing the development of a new 
neurological deficit that persists > 24 hours, 
or worsening of previous neurological 
symptoms that persists > 24 hours.  
Left Arm/Hand Ischemia: 
Malperfusion of the left arm/hand as a result 
of an arterial thrombosis/embolus resulting 
in symptoms of pain, parasthesias, 
pulselessness, paralysis, pallor, or 
poikilothermia evidenced on Doppler 
ultrasound, CTA, or MRA imaging.  
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 105 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
SECONDARY OBSERVATIONS DEFINITIONS 
All-Cause Mortality: 
Death from any cause. 
Device, Procedure, 
and/or Disease (TAA)-
Related Adverse Events 
Disease-Related: Any adverse event that occurs as a result of 
the aortic disease treated by the Valiant Mona LSA Thoracic 
Stent Graft System.  
Device-Related: Any adverse event that occurs as a result of any 
defect, malfunction, or failure of the Valiant Mona LSA Thoracic 
Stent Graft System.  
Procedure-Related: Any adverse event that occurs within 30 
days of a procedure to treat the aneurysm or a stent graft device 
malfunction/failure unless specifically shown not to be related to 
that procedure. 
Serious Adverse Events 
(SAEs) 
A serious adverse event is an adverse event that: 
• Led to a death. 
• Led to a serious deterioration in the health of the subject that 
resulted in: 
a. a life threatening illness or injury, or 
b. a permanent impairment of a body structure or a 
body function, or 
c. in-patient hospitalization or prolongation of existing 
hospitalization 
d. medical or surgical intervention to prevent life-
threatening illness or injury or permanent 
impairment to a body structure or a body function. * 
• Led to fetal distress, fetal death, or a congenital abnormality or 
birth defect. 
* Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without 
serious deterioration in health, is not considered a serious 
adverse event.  
* An observational, overnight hospital admission < 24 hours in 
duration does not qualify an adverse event as a serious adverse 
event. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 106 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Secondary Index 
Procedures 
An additional procedure required to achieve successful 
treatment of the subject during the index procedure including 
placement or use of additional component: 
• 
Deployment of secondary endoluminal prosthesis within 
the primary prosthesis. 
• 
Balloon dilatation of anchor zones. 
Secondary Endovascular 
Procedure 
A secondary endovascular procedure is defined as any 
endovascular procedure performed during the relevant time 
period which involves the targeted vascular segment treated by 
the Valiant Mona LSA Thoracic Stent Graft System in which 
there is either manipulation of the existing Valiant Mona LSA 
devices or implantation of any additional stent graft devices. 
Conversion to (Open) 
Surgical Repair: 
Primary Conversion:  
Conversion from endovascular to open repair required at the 
time of the index procedure. 
Secondary Conversion:  
Conversion from endovascular to open repair required at a time 
beyond the initial index procedure. 
Surgical 
Revascularization of the 
LSA 
Open surgical bypass to restore blood flow through the LSA. 
Endoleak 
Defined by the presence of contrast outside the lumen of the 
endoluminal graft but within the aneurysm sac 
Exclusion of aneurysm  
Defined as the absence of type I or III endoleak associated with 
the absence of growth > 5 mm of the maximum measurable 
aneurysm diameter; reference diameter is the diameter 
measured at first post-operative imaging exam. 
Exclusion of penetrating 
aortic ulcer (PAU)  
Defined as the absence of type I or III endoleak associated with 
the absence of growth > 5 mm of the maximum measurable 
aortic diameter at the level of PAU; reference diameter is the 
diameter measured at first post-operative imaging exam. 
Exclusion of false lumen 
(dissection)  
Defined as the coverage of the primary entry tear of dissection 
associated with the thrombosis of false lumen at the level of 
stent graft. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 107 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Primary intimal tear false 
lumen perfusion (PIT 
FLP) 
Defined as flow from a proximal aortic source through the 
primary intimal tear (PIT), into the aortic false lumen (similar to a 
Type IA endoleak after treatment of aneurysms). 
Proximal aorta false 
lumen perfusion (PA FLP) 
Defined as flow from an aortic source proximal to the 
endovascular stent-graft, through an entry tear proximal to the 
PIT, into the aortic false lumen. 
Distal aorta false lumen 
perfusion (DA FLP) 
Defined as flow from an aortic source distal to the endovascular 
stent-graft, through fenestrations in the dissection septum, 
secondary aortic tears, or re-entry points, into the aortic false 
lumen. 
Proximal branch false 
lumen perfusion (PB FLP) 
Defined as flow into the aortic false lumen via retrograde flow 
from aortic arch branch vessels. 
Distal branch false lumen 
perfusion (DB FLP) 
Defined as flow into the aortic false lumen via retrograde flow 
from distal branch vessels in the chest (intercostals), abdomen 
(e.g., mesenteric, renal), or pelvis (iliac). 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 108 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX C – ADVERSE EVENT DEFINITIONS 
ADVERSE EVENT DEFINITIONS 
In addition to the definitions provided in Appendix B – Major Adverse Event Definitions, the 
following definitions apply to expected adverse events that may occur and must be 
reported throughout this clinical study. Events reported should represent a new onset or 
increase in the severity of the condition from the time of enrollment (the subject is 
considered to be enrolled at the time of arterial access with the intent to implant the 
Valiant Mona LSA Stent Graft).  
A. PULMONARY 
COMPLICATIONS 
DEFINITION 
Pneumonia 
Lung inflammation and/or infection as determined by physical, radiographic, and 
laboratory findings requiring treatment with antibiotics, inhalation therapy, 
intubation, or suctioning. 
Atelectasis 
Complete or partial collapse of lung tissue as determined by physical, 
radiographic, and laboratory findings requiring treatment with respiratory 
therapy, incentive spirometry, oxygen, medications, inhalation therapy, or 
bronchoscopy. 
Pulmonary 
Embolism 
Blockage of an artery in the lungs by a blood clot or other material moving 
through the venous bloodstream as evidenced by sudden onset of pleuritic 
chest pain, cough, hemoptysis, hypoxia, tachycardia, and a positive 
ventilation/perfusion scan. 
Pulmonary Edema 
Abnormal accumulation of fluid in the lungs. 
Other Pulmonary 
Complications 
Any other significant pulmonary complication that causes clinically relevant 
changes in the subject’s health, e.g., wheezing, pleural effusion, pneumothorax, 
chronic obstructive pulmonary disease. 
 
B. BLEEDING 
COMPLICATIONS 
DEFINITION 
Bleeding, Post-
Procedural 
Post-procedural bleeding > 750 cc after the subject leaves the operating room.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 109 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Coagulopathy 
An abnormality of blood clotting function (e.g., disseminated intravascular 
coagulopathy or thrombocytopenia) documented by appropriate laboratory 
studies and requiring therapy with medication or transfusion.  
Hematoma 
An abnormal localized collection of blood (clotted or partially clotted) situated 
within an organ or a soft tissue space, requiring surgical intervention, 
evacuation, transfusion or prolonged hospitalization. 
Seroma 
A mass caused by the localized accumulation of serum within a tissue or organ. 
Gastrointestinal 
bleeding 
Bleeding of the gastrointestinal tract as evidenced by hematemesis, 
hematochezia, melena, or occult blood in the stool and confirmed by laboratory 
and/ or endoscopic findings. 
Retroperitoneal 
Bleed 
Bleeding into the retroperitoneal space due to trauma, surgery, or 
percutaneous puncture of an artery or vein. 
Other Bleeding 
Complications 
Any other significant bleeding complication that causes clinically relevant 
changes in the subject’s health, e.g., intracranial hemorrhage, hemothorax, 
visceral hemorrhage, or intraperitoneal hemorrhage.  
 
C. CARDIAC 
COMPLICATIONS 
DEFINITION 
Angina 
Chest, neck, arm, back, or other pain related to decreased coronary blood flow. 
Unstable Angina 
Changes in previously reported chest pain type (e.g. chest pain at rest, more 
frequent, or more severe), unrelieved by anti-anginal medications in a subject 
with known coronary artery disease without significant elevations in cardiac 
enzymes. 
Arrhythmia 
The development of a new atrial and/or ventricular arrhythmia, significant 
increase in the severity of a preexisting arrhythmia, or any episode of cardiac 
arrest. 
Congestive Heart 
Failure 
Failure of the heart to pump blood with normal efficiency. Development of an 
acute episode of or exacerbation of existing low cardiac output or fluid overload 
accompanied by peripheral and/or pulmonary edema. 
Other Cardiac 
Complications 
Any other significant cardiac complication that causes clinically relevant 
changes in the subject’s health, e.g., cardiac tamponade, pericarditis. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 110 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
D. RENAL 
FUNCTION 
COMPLICATIONS 
DEFINITION 
Renal 
Insufficiency 
Decrease in and inadequacy of the filtration function of the kidney resulting 
from disease (e.g., diabetes, cancer, hypertension, or glomerulonephritis). If 
creatinine levels are available, an increase of > 25% above the pre-procedure 
creatinine level, excluding cases in which regardless of the 25% increase, the 
creatinine levels are still within the normal ranges. 
Other Renal 
Complications 
Any other significant renal complication that causes clinically relevant changes 
in the subject’s health, e.g., infarct of kidney, kidney stones/tumors. 
 
E. WOUND 
COMPLICATIONS 
DEFINITION 
Dehiscence 
Surgical complication in which the sutured wound separates along the incisional 
line.  
Lower Limb 
Edema 
Abnormal accumulation of fluid in a lower extremity, defined in this study by a 
circumference of the affected limb that is 2 cm greater than that of the 
contralateral extremity more than 2 weeks following treatment. 
Lymphocele/ 
Lymph Fistula 
Cystic mass containing lymph occurring at the incision or puncture site > 3 days 
after surgery. 
Wound Infection 
Infection and inflammation of the incision or puncture site requiring drainage 
and/or debridement in addition to antibiotic therapy, e.g., cellulitis. 
Other Wound 
Complications 
Any other significant wound complication that causes clinically relevant changes 
in the subject’s health, e.g., tissue necrosis, false aneurysm. 
 
F. GASTRO-
INTESTINAL 
COMPLICATIONS 
DEFINITION 
 
Bowel 
Obstruction 
The clinical picture of mechanical bowel obstruction, in which the transit of 
products of digestion is blocked, confirmed by abdominal x-ray studies, 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 111 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
requiring nasogastric or long tube decompression (with or without laparotomy 
for adhesiolysis). 
Bowel Necrosis 
Death of part of the intestine after its blood supply is interrupted. 
Ileus 
Intestinal paralysis that may lead to obstruction. 
Other 
Gastrointestinal 
Complications 
Any other significant gastrointestinal complication that causes clinically 
relevant changes in the subject’s health, e.g., pancreatitis, cholecystitis, gall 
stones, biliary tract stones, appendicitis, gastric ulcer (not bleeding), gastritis, 
positive stool culture, nausea and vomiting (not related to medications), 
gastroenteritis, hemorrhoids, constipation, diarrhea, esophageal hernia. 
 
G. VASCULAR 
COMPLICATIONS 
DEFINITION 
Aortic Dissection 
Acute (< 2 weeks) or chronic (> 2 weeks) intimal tear resulting in propagation of 
blood within the aortic media, usually distally, but sometimes retrograde, with 
numerous reentry sites. 
Aortic Rupture 
The tearing apart of the aortic tissue. Signs of aortic rupture include 
hemothorax, unrelenting chest or back pain, or hypotension refractory to 
medical management for a period > 2 days. 
Aneurysm 
Rupture 
Rupture or perforation of the targeted aneurysmal sac as detected by 
angiography, CT scan, and/or direct observation at surgery or autopsy. 
Aneurysm rupture should be reported as either procedure-related aneurysm 
rupture, i.e., perforation of the aneurysm during the course of the implantation 
procedure, or as a late aneurysm rupture that follows device deployment. For 
purposes of this study, Aneurysm Rupture only applies to the aneurysm which 
was the target treatment of the Mona LSA Thoracic Stent Graft System. Other 
aneurysm ruptures, which were not treated by the Mona LSA Thoracic Stent 
Graft System, should be captured in the “Vascular, Other” section of the eCRF. 
Arterial or Venous 
Occlusion 
Vessel lumen narrowing by atherosclerotic plaque, thrombus, or embolism 
causing occlusion of blood supply to the extremities. 
Arteriovenous 
Fistula 
Formation of an abnormal connection between the lumens of an artery and a 
vein as documented by CT, ultrasound, angiography, or direct observation. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 112 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
G. VASCULAR 
COMPLICATIONS 
DEFINITION 
Embolism 
The obstruction of a blood vessel by a blood clot or foreign substance, e.g., air, 
fat, bacteria) that has traveled through the bloodstream from another anatomic 
location. 
Penetrating 
Atherosclerotic 
Ulcer 
(Saccular 
Aneurysm) 
Atherosclerotic aortic intimal erosion resulting in penetration initially into the 
internal elastic lamina and then through to the media, associated with an 
intramural hematoma. 
Pseudoaneurysm 
Enlargement of the aorta, iliac, femoral or arteries, due to vessel injury and a 
contained leakage of blood. A pseudoaneurysm, unlike a true aneurysm, may 
contain some or all of the medial layer, the adventitia, and peri vessel tissue and 
are most commonly associated with operative procedures, trauma, and/or 
infection. 
Stenosis 
A reduction in the diameter of the vessel lumen when compared to the reference 
diameter, as documented by angiography, which requires intervention and is 
related to the procedure, e.g., access vessel.  
Thrombosis  
Clotting within a blood vessel which may occlude the vessel, causing infarction of 
tissues supplied by the vessel, or be attached to the vessel or heart wall without 
obstructing the lumen. 
Transection 
Acute (< 2 week) or chronic (> 2 week), partial or full, circumferential tear in the 
aortic wall. 
Tissue Necrosis 
Death of body tissue secondary to decreased blood supply. 
Gangrene 
Tissue necrosis due to obstruction, loss, or diminution of blood supply that may 
be localized or extensive (involving an entire extremity). 
Perforation 
Defined as a tear or hole in an access vessel wall or the aorta confirmed by 
extravasation of contrast under fluoroscopy. 
Vessel Disruption 
Interruption of the continuity of the vessel wall. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 113 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
G. VASCULAR 
COMPLICATIONS 
DEFINITION 
Vessel 
Rupture/Dissectio
n 
Rupture: Forcible tearing or disruption of tissue.  
Dissection: Extrusion of blood into the connective tissue framework of a vessel 
wall, causing separation of the natural vessel layers. 
Other Vascular 
Complications 
Other vascular events that cause clinically relevant changes in the subject’s 
health. This will also include ruptures of aneurysms which were not the target 
lesion of the Mona LSA Stent Graft System. 
 
H. NEUROLOGIC 
COMPLICATIONS 
DEFINITION 
Change in Mental 
Status 
The new onset of changes in brain functioning causing defects in memory, 
alertness, orientation, judgment, emotional control, perception or behavior. 
Femoral 
Neuropathy 
Femoral nerve dysfunction as evidenced by pain and/or numbness in the 
anterior thigh associated with quadriceps muscle weakness and decreased 
patellar reflex lasting > 1 month after treatment. 
Nerve 
Injury/Peripheral 
Neuropathy 
Direct damage to nerves surrounding the access site, operative field, or 
implantation site, and the resultant signs and/or symptoms of such damage. 
Transient 
Ischemic Attack 
A brief episode of neurological dysfunction caused by focal brain or retinal 
ischemia with clinical symptoms typically lasting 1 - 24 hours and without 
evidence of acute infarction. 
Other Neurologic 
Complications 
Any other neurologic complication that causes clinically relevant changes in the 
subject’s health, e.g., leg weakness, foot drop, weakness/numbness in 
hand/fingers, pain (headache, backache), Bell’s palsy, spinal stenosis, confusion, 
vertigo. 
Paraparesis 
Partial loss of voluntary motor function of lower extremities 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 114 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
I. OTHER 
EVENTS 
DEFINITION 
Anesthetic 
Complications 
Reaction or complication caused by administration of an anesthetic. 
Loss of Patency 
of the Stent Graft: 
Loss of continued blood flow through the stent graft treated section of the 
vessel. 
Anastomotic 
False Aneurysm 
The development of an anastomotic false aneurysm at the proximal or distal 
end(s) of the device or surgical graft as determined by CT scan, ultrasound 
angiography, and/or direct observation at surgery or autopsy. 
Aortoenteric 
Fistula 
Formation of an abnormal communication tract between the lumens of the 
aorta and the gastrointestinal tract or erosion of the prosthetic body into the 
intestine. 
Erectile 
Dysfunction/Imp
otence 
Subjective report of failure to resume the degree of sexual function 
documented preoperatively within 6 months of the index procedure. 
Post-Implant 
Syndrome 
Self-limiting symptoms of back pain and fever of unknown origin > 101° F 
(without leukocytosis) lasting longer than 48 hours post index procedure. 
Genitourinary 
Symptomatic and asymptomatic genitourinary complications with subsequent 
attendant problems including ischemia, erosion, fistula, incontinence, 
hematuria, infection (cystitis, urethritis, prostatitis, epididymitis, 
pyelonephritis). 
Sepsis 
Systemic infection with confirmed positive blood cultures. 
Neoplasm 
Any tumor or uncontrolled growth of cells. 
Prosthesis 
Infection 
The development of a perigraft infection confirmed by direct examination, CT, 
and/or perigraft aspiration, and not associated with aortoenteric, fistula, or 
erosion. 
Other 
Complications 
Any event that causes clinically relevant changes in the subject’s health, e.g.,  
allergic reaction to dye, anemia. 
 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 115 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX D – DEVICE-RELATED TECHNICAL OBSERVATIONS 
TECHNICAL OBSERVATIONS 
If a defect, malfunction, or failure of the Valiant Mona LSA Thoracic Stent Graft System is 
noted, or the system does not function according to its design intent (including endoleaks), 
and the event is not related to any untoward medical occurrence in a subject or place the 
subject at increased risk, then the event will be recorded as a “technical observation” (refer 
to Section 9.8—Technical Observations). For example, if there is stent graft migration as 
noted on a follow-up imaging study, but has not resulted in any adverse consequence to 
the subject, then the migration will be reported as a technical observation. Such 
observations will be reported separately from device-related adverse events on the Site 
Imaging Report Form. If the technical observation included an adverse event, then the 
appropriate adverse events forms must be completed as well.  
 
TECHNICAL 
OBSERVATIONS 
DEFINITION 
 
Access Failure 
Inability to insert device due to mechanical failure or anatomic conditions of 
the femoral or iliac arteries. 
Aneurysm Expansion 
Aneurysm maximum diameter increase of > 5 mm as compared to the 
discharge contrast enhanced imaging measurements. 
Extrusion/Erosion 
Extrusion or erosion of the metal frame through the full thickness of the 
vessel wall as determined by CT, angiography, and/or direct observation at 
surgery or autopsy. 
Stent Graft Fabric 
Defect 
Defect in the fabric of the stent graft. 
General Stent Graft 
Complications 
Any device-related technical observation not captured in the other Technical 
Observation categories. 
Lumen Obstruction 
Unintentional obstruction of flow through the vascular lumen due to twisting 
(obstruction in the vertical plane) or kinking (obstruction in the horizontal 
plane) of the stent graft, oversizing, failure of the implant to fully open, or any 
other cause.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 116 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
TECHNICAL 
OBSERVATIONS 
DEFINITION 
 
Deployment Failure 
Deployment failure due to patient anatomy or mechanical failure. This 
specifically refers to deployment of the stent graft from the delivery system. 
Bare Stent Fracture 
Fracture or breakage of the bare stent. 
Stent Graft Wireform 
Fracture 
Fracture or breakage in stent graft wireform. 
Branch Stent Graft 
Occlusion 
A complete blockage of the lumen of the stent graft as evidenced by CT, 
angiography, ultrasound, or other appropriate imaging modality, and/or 
pathological analysis. 
Stent Graft Stenosis 
Reduction in the diameter of the stent graft lumen as compared to the 
reference diameter. 
Stent Graft 
Thrombosis 
Hemodynamically significant thrombus formation within the lumen of the 
device or surgical graft material as determined by ultrasound, CT scan, 
angiography, and/or pathological examination. Classify as to the location of 
the thrombosis: branch stent graft or main stent graft. 
Stent Graft Migration 
Evidence of movement of the stent graft relative to fixed anatomic 
landmarks, which is not due to remodeling of the subject’s vasculature. 
Proximal migration of the main stent graft is observed when the main stent 
graft movement is > 10 mm antegrade. Distal migration of the main stent 
graft is observed when the main stent graft moves > 10 mm caudal, relative 
to fixed anatomic landmarks. Proximal migration of the branch stent graft is 
observed when branch stent graft movement is > 10 mm into/towards the 
aorta. Distal migration of the branch stent graft is observed when movement 
is > 10 mm away from the aorta relative to fixed anatomical landmarks.  
 
ENDOLEAKS 
DEFINITION 
Endoleak – Type I 
Blood flow into the aneurysm sac from the proximal anchoring site (proximal 
endoleak) or the distal anchoring site (distal endoleak) of the device. 
Endoleak – Type II 
Retrograde flow into the aneurysmal sac from patent branch arteries.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 117 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
ENDOLEAKS 
DEFINITION 
Endoleak – Type III 
Leak from the mid-graft region due to the defect of fabric or between the 
segments of the modular graft (junctional endoleak). 
Endoleak – Type IV 
Transgraft leak due to fabric porosity. 
Endoleak – Type V 
Aneurysm enlargement in the absence of any demonstrable perfusion of the 
aneurysmal sac. 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 118 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX E – INFORMED CONSENT TEMPLATE 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 119 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX F – LABELING 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 120 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 121 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX G – ASSESSMENTS AND GUIDELINES 
 
• 
ASA Anesthesia Classification 
• 
NIH Stroke Scale  
• 
The Folstein Mini-Mental Status Examination (MMSE) 
• 
The Modified Rankin Scale (mRS) 
• 
TAA Anatomical Characteristics and Dimensions Diagram 
• 
Modified SVS/AAVS Medical Comorbidity Grading System 
• 
Imaging Recommendations 
 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 122 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS 
CLASSIFICATION SYSTEM********************* 
 
Class 
Description 
I 
A normal healthy patient. 
II 
A patient with mild systemic disease. 
III 
A patient with severe systemic disease. 
IV 
A patient with severe systemic disease that is a constant threat 
to life. 
V 
A moribund patient who is not expected to survive without the 
operation. 
VI 
A declared brain-dead patient whose organs are being removed 
for donor purposes. 
 
 
 
                                                 
********************* Per American Society of Anesthesiologists website: 
www.asahq.org/clinical/physicalstatus.htm.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 123 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
MODIFIED SVS/AAVS MEDICAL COMORBIDITY GRADING SYSTEM 
SVS RISK FACTORS 
Components 
 
0 (Absent) 
1 (Mild) 
2 (Moderate) 
3 (Severe) 
Age (years) 
< 55 
55-69 
70-85 
> 85 
Hypertension 
None  
Cut-off point: 
diastolic 
pressure usually 
lower than 90 
mmHg 
Controlled  
Cut-off point: 
diastolic pressure 
usually lower than 
90 mmHg) with 
single drug 
Controlled with 2 
or more drugs 
Uncontrolled 
hypertension
††††††††††††††††††††† 
Cardiac  
Asymptomatic, 
with normal ECG 
Asymptomatic, 
but with either 
remote MI by 
history (6 
months), occult MI 
by ECG, or fixed 
deficit on 
dipyridamole 
thallium or similar 
scan 
Any one of the 
following: 
• Stable angina  
• No angina but 
significant 
reversible 
perfusion 
deficit on 
dipyridamole 
thallium scan 
• Significant 
silent ischemia 
(1% of time) on 
Holter 
monitoring  
• EF = 25-45% 
• Controlled 
ectopy or 
Any one of the 
following:  
• Unstable 
angina  
• Symptomatic 
or poorly 
controlled 
ectopy or 
arrhythmia 
(chronic or 
recurrent) 
• Poorly 
compensated 
or recurrent 
CHF  
• EF < 25%  
• MI within 6 
months with no 
intervention 
                                                 
††††††††††††††††††††† Physicians generally use the full armamentarium of drugs available to them. As such the key issue with 
respect to risk classification is whether the hypertension is controlled and not necessarily how many drugs were used to 
establish effective control. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 124 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Components 
 
0 (Absent) 
1 (Mild) 
2 (Moderate) 
3 (Severe) 
asymptomatic 
arrhythmia  
• History of CHF 
that is now well 
compensated  
(CABG, 
angioplasty or 
stenting) 
Pulmonary 
Asymptomatic, 
normal chest X-
ray, pulmonary 
function tests 
within 20% of 
predicted 
Asymptomatic or 
mild dyspnea on 
exertion, mild 
chronic 
parenchymal 
radiograph 
changes, 
pulmonary 
function tests 65-
80% of predicted 
Between 1 and 3 
Vital capacity 
<1.85L, FEV1 
<1.2L or <35% of 
predicted, 
maximal voluntary 
ventilation <50% 
of predicted, 
PCO2 >45 mmHg, 
supplemental O2 
medically 
necessary, or 
pulmonary 
hypertension 
Renal 
No known 
disease, normal 
creatinine  
Moderately 
elevated 
creatinine level, as 
high as 2.4 mg/dL 
Creatinine level 
2.5-5.9 mg/dL 
Creatinine level 
>6.0 mg/dL, or on 
dialysis, or with 
kidney transplant 
Note: ECG = electrocardiography; MI = myocardial infarction; CHF = congestive heart failure; VC = vital capacity; FEV1 = 
forced expiratory volume in 1 second; PCO2 = partial pressure of carbon dioxide.  
 
NIH STROKE SCALE SCORING SYSTEM 
Score 
Description 
0 
No stroke. 
1-4 
Minor stroke. 
5-15 
Moderate stroke. 
15-20 
Moderate/severe stroke. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 125 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Score 
Description 
21-42 
Severe stroke. 
Per NIH Stroke Scale Training, Part 2. Basic Instruction. Department of Health and Human Services, National 
Institute of Neurological Disorders and Stroke. The National Institute of Neurological Disorders and Stroke 
(NINDS) Version 2.0 
 
THE FOLSTEIN MINI-MENTAL STATUS EXAMINATION (MMSE) 
Score 
Description 
27-30 
Normal cognition. 
21-26 
Mild cognitive impairment. 
10-20 
Moderate cognitive impairment. 
<10 
Severe cognitive impairment. 
The Mini-Mental State Examination score and the clinical diagnosis of dementia. J Clin Epidemiol. 1994 Sep 
;47(9):1061-7. 
 
THE MODIFIED RANKIN SCALE (MRS) 
Score 
Description 
0 
No symptoms. 
1 
No significant disability. Able to carry out all usual activities, 
despite some symptoms.  
2 
Slight disability. Able to look after own affairs without 
assistance, but unable to carry out all previous activities.  
3 
Moderate disability. Requires some help, but able to walk 
unassisted.  
4 
Moderately severe disability. Unable to attend to own bodily 
needs without assistance, and unable to walk unassisted.  
5 
Severe disability. Requires constant nursing care and attention, 
bedridden, incontinent.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 126 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
6 
Dead.  
PDF of Modified Rankin Scale Score. http://www.strokecenter.org/wp-
content/uploads/2011/08/modified_rankin.pdf.  
 
CLASSIFICATION OF AORTIC ATHEROMA 
Grade 
Description 
I 
Normal to mild intimal thickening 
II 
Severe intimal thickening  
III 
Atheroma protruding < 5mm into lumen 
IV 
Atheroma protruding ≥ 5mm into lumen 
V 
Atheroma with a mobile component 
Katz ES, Tunick PA, Rusinek H, et al: Protruding aortic atheromas predict stroke in elderly patients undergoing 
cardiopulmonary bypass: Experience with intraoperative transesophageal echocardiography. JACC 1992;20 (1):70–77.

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 127 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
ANATOMICAL CHARACTERISTICS AND DIMENSIONS DIAGRAM 
 
 
                                            Figure 5: Anatomical characteristics and dimensions diagram 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 128 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
THORACIC DISSECTION MEASUREMENTS  
Information pertaining to the measurements for chronic dissection, maximum thoracic 
aortic diameter and true and false lumen diameters should be recorded on the eCRFs. Refer 
to Figure 6 and 7 below for an overview of these measurements.   
 
Figure 6: Thoracic Dissection Measurements 
• D1: Diameter at distal margin of left CCA (long axis of ellipse).  
• D2 (not shown): Diameter at proximal landing zone if different from D1.  
• L1: Distance from distal margin of left CCA to start of most proximal tear. (Inclusion 
criteria: ≥20mm.) 
• L2: Total length of aortic (thoracic and abdominal) dissection. 
• L3 (not shown): Total thoracic aortic length (left CCA to celiac). 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 129 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
Figure 7: Maximum Thoracic Aortic/True/False Lumen Diameter Measurements 
 
• All measurements should be based on centerline (along the TL) orthogonal 3D 
reconstructions of contrast CTA scan. 
• AD1 (maximum thoracic aortic centerline diameter) = Maximum diameter anywhere 
along the thoracic aorta defined as distal margin of left CCA origin to proximal margin of 
celiac trunk (major axis of an ellipse). 
• AD2 (maximum TL diameter) = inner wall-to-inner wall length along the minor axis of the 
TL ellipse. AD2 will be measured at the same location as AD1. 
• AD3 (maximum FL diameter) = The maximum distance from the inner point of AD2 to the 
outer wall. AD3 will be measured at the same location as AD1. 
• During follow-up, AD1, AD2, and AD3 should be measured at the point of maximum 
diameter of the DTA and additionally at the point of maximum diameter over the length 
of the endografted segment. If the point of maximum diameter for the entire DTA is over 
the endografted segment, only one set of measurements is needed. 
• During follow up, status of FL: patent, partially thrombosed, thrombosed. This must be 
assessed on the DELAYED phase of a triple-phase CTA. 
False 
Lumen 
True 
Lumen 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 130 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
IMAGING GUIDELINES 
 
ANGIOGRAPHIC IMAGING RECOMMENDATIONS 
Current imaging of stent graft patients includes CT scan, with and without contrast 
medium, and a chest x-ray. If patients cannot tolerate contrast medium, non-contrast CTA 
should be performed. Additional imaging modalities (i.e., magnetic resonance imaging) 
should be considered in combination with non-contrast CTA for patients who have impaired 
renal function or intolerance to contrast media. 
Imaging should be scheduled based on the physician’s clinical assessment of the patient 
pre- and post-implantation of the stent graft. Both the type of imaging modality and the 
frequency of imaging should follow the study time points and guidelines. 
 
CONTRAST ENHANCED SPIRAL CHEST CT SCAN 
The accuracy and reproducibility of the CT Angio endpoints of this protocol are dependent 
upon each Investigator’s commitment to rigorous image acquisition techniques. The 
following guidelines are provided for data acquisition and should be used pre and post 
procedure. Measurements to be recorded are also described. 
CT Angio with 3D reconstructions will be analyzed using the qualitative morphologic criteria 
and quantitative methods established for the Thoracic Branch Stent Graft System Clinical 
Study. The entire pre- and post-procedural CT Angio will be reviewed for the 
documentation of standardized pre- and post-procedural morphologic criteria. Selected 
frames from the films will be analyzed using computer-assisted automated edge-detection 
algorithms and these computer-assisted methods are completely dependent on image 
acquisition quality. CT Angio with 3D reconstructions will be used to assess stent graft. It is 
important that it captures the entire stent-graft to adequately assess the device 
appropriately. 
The image data should be submitted in DICOM format using any of the following data 
storage media: CDROM, DVDROM, or an USB flash drive. DICOM data sent to the Medtronic 
Vascular Clinical Study Team should not utilize “lossy compression”. CT’s should be 
obtained at pre-implant, 1 month, 6 months, 12 months and annually for a total of five (5) 
years post-implant. Images should be submitted to Medtronic Vascular.  
DIRECTION OF DATA ACQUISITION 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 131 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Chest CT examinations will be performed with the direction of data acquisition 
cephalocaudal. 
 
REGION OF INTEREST 
After obtaining anteposterior topogram, the region of interest will be from the cephalic limit 
to include the origins of the great vessels (brachial-cephalic trunk, left common carotid, left 
subclavian), and include a minimum of 5mm above the bifurcation of the LSA. The caudal 
limit will be at the level of the femoral bifurcation for the pre-implant CT and superior 
mesenteric artery for follow-up CT scans. 
 
RECONSTRUCTION 
The spiral acquisition will consist of continuous 360º tube rotations. Examinations could be 
reconstructed with a slice increment of 1.5 mm, and overlapping reconstructions are 
recommended. The recommended image reconstruction parameters are a slice increment 
of 0.8 mm or less, and an axial plane pixel resolution of 0.625mm or less. A zoom factor of 
2.8-3.0 or a field of view of 20 to 30 cm centered on the aorta will be used. 
 
CONTRAST 
Properly timed intravenous injections of contrast media, preferably non-ionic, will be given 
to visualize arterial structures. It is recommended that the following CT series are 
submitted: Non-contrast (Native), Contrast (Arterial), and Delay (Venous). 
Consider the appropriate site for injection of contrast (i.e., injection of contrast via the right 
upper extremity will minimize artefacts). 
 
THREE-DIMENSIONAL RECONSTRUCTION 
After volumetric data acquisition, 3D reconstruction should be performed with shaded 
surface rendering and maximum intensity projections and/or multiple-object interactive 
shaded surface display. Multiple object shaded surface display should include independent 
display of calcified plaque, contrast enhanced blood flow and thrombus non-calcified 
plaque. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 132 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Multiple image reconstructions will be generated to display relevant anatomic structures for 
measurement and evaluation. Additional planes of aortic aneurysms, such as coronal, 
sagittal, or oblique two-dimensional reformations may be generated and displayed. 
 
X-RAY 
Chest x-rays (completed per the Investigator’s standard of care) may be used to assess 
stent fracture. It is important that the AP projection captures the entire stent-graft to 
adequately assess the device for fracture. Lateral projection will be helpful in observing the 
stent-graft in the proximal segment of the descending thoracic aorta that has 
anterior/posterior angulation. Bilateral obliques will be helpful in observing the stent graft in 
the distal segment of the descending thoracic aorta that has lateral angulation or in tortuous 
anatomy. 
Chest x-rays will be obtained per the investigational site’s standard of care. Images should 
be submitted to the Medtronic Vascular Clinical Study Team.  
 
MRI OR MRA 
Patients with impaired renal function, i.e. renal insufficiency, may also be considered for 
magnetic resonance imaging or angiography (MRI, MRA) in facilities that have expertise in 
this area. Artifact may occur related to the stent, and care should be used to insure adequate 
imaging of the outer aneurysm wall to assess aneurysm size is obtained. Additionally, a 
complete series of axial reconstructions are requested in order to compare aneurysm 
measurements taken from CT data. The image reconstruction interval should not exceed 3 
mm. Volume measurement may be helpful if the aneurysm is not clearly shrinking. If there 
are concerns regarding imaging of calcified areas, fixation sites, or the outer wall of the 
aneurysm sac, adjunctive CT without contrast may be needed. 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 133 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
SUPPLEMENTARY IMAGING RECOMMENDATIONS 
Additional radiological imaging may be necessary to further evaluate the stent graft in situ 
based on findings. The following recommendations may be considered: 
If there is evidence of poor position of the stent graft, severe angulation, kinking or 
migration of the stent graft on chest x-rays, a spiral CT should be performed to assess 
aneurysm size and the presence or absence of an endoleak. 
If a new endoleak or increase in descending thoracic aneurysm size is observed by CT, 
adjunctive studies such as 3-D reconstruction or angiographic assessment of the stent 
graft and native vasculature may be helpful in further evaluating any changes of the stent 
graft or aneurysm.  
 
 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 134 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX H – EXPLANT INSTRUCTIONS 
 
EXPLANT AND AUTOPSY PROCEDURE FOR ENDOVASCULAR PATIENTS 
SURGEON AND SITE RESPONSIBILITY 
 
NOTE: Priority should be given to patient health and safety at all times during the explant 
procedure. 
 
A. If the explant is part of a late conversion to an open-surgical procedure, consideration of 
the patient is foremost. The surgeon should remove ONLY the endovascular prosthesis, 
damaging or altering the device as little as possible yet providing optimal surgical care to 
the patient. 
B. If the explant is performed on a cadaver, the surgeon should carefully view the adjacent 
body organs and excise the intact aorta containing the endovascular prosthesis, 
including 1cm of tissue adjacent to the proximal and distal fixation sites to facilitate 
histological assessment. 
C. It is important that care be given during the collection, handling and examination of the 
implant to ensure that it is not damaged or altered. 
• 
Particular care should be taken to avoid applying force, traction, or torsion to the 
stent graft during the explant. 
• 
Care should be exercised to avoid excessive manipulation with metallic instruments 
at the proximal and distal fixation sites whenever possible. 
• 
Stent graft or post mortem specimen should be placed in formalin as is. Do not 
attempt to clean or remove organic debris. 
D. Using the Explant Procedure Observation Form (UC200103088EN), the physician should 
accurately and fully document the explant procedure and the stent graft ex situ. Any 
possible trauma applied to the device, e.g., clamping, twisting, torsion, or traction should 
also be documented. 
• 
Physician operation notes may also be used to document the procedure and the 
characteristics of the stent graft prior to and after explant from the body. 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 135 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Mark components that separate during explant. Attach suture or hemoclip to 
anterior side and on the proximal end for proximal cuffs and distally for distal 
components. 
E. Follow procedures from Explant Return Instructions (UC200103091) included in the 
explant kit for packaging and return of device to Medtronic. 
 
EXPLANT RETURN INSTRUCTIONS: 
 
1.0 
Complete the following forms: 
Explant Procedure Observation Form (UC200103088EN). This form is to be completed at 
the time of explant procedure. 
Patient Identification Peel-off Labels (UC200103089EN). Using permanent ink, complete 
the two labels provided. Place one completed label on the inner plastic container; place the 
second completed label on the outer metal container  
Air bill Fill in shipper information. 
2.0 
Secure the explant in the explant kit for shipping. 
 
• 
Place the explanted device and any associated organic tissue into the labeled inner 
plastic container in a 10% neutral buffered formalin (3.7-4% Formaldehyde) solution to 
maintain tissue integrity. 
 
Note: Any specimen too large for the provided inner container may be sent in any 
securely closed container and placed with provided packing in Metal container and box. 
• 
Seal container with red tape (provided in kit). The tape should be stretched clockwise 
around the cap and the container. Place plastic container in absorbent bag. 
• 
Place the absorbent bag (with plastic container) inside the labeled metal container. Place 
lid on metal can and seal with locking ring. Place the can in the cardboard box. 
• 
Place the completed Explant Procedure Observation Form and implant and explant 
operative reports, if available, inside the moisture-resistant plastic bag provided. A 
Record of Disclosure of Health Information for Public Purposes is in included for your 
convenience and can be placed in the patients file. 
• 
Securely seal the box with clear tape (provided in kit). Affix the Shipping labels to the 
outside of the box. Arrange for pickup from Shipping Company.  

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 136 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
If you have questions about shipping the device, need additional information, or desire additional 
Explant Kits, please contact the Explant Department, at (707) 591-7672 or (800)-465-5533.  
 
Thank you for completing the Explant Forms and returning the device. Medtronic uses this 
information to meet FDA requirements and track product performance. 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 137 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
EXPLANT PROCEDURE OBSERVATION REPORT 
 
PLEASE COMPLETE THE INFORMATION BELOW: 
 
PATIENT INFORMATION 
 
Patient IDE/ Study ID_____________________________________ 
 
Name:_________________________________________________ 
 
DOB (Month/Day/Year): _____/_____/_____ 
  
IMPLANT INFORMATION  
 
Date of Implant: _____/_____/_____ 
 
Implanting Physician: ____________________________________ 
Implanting Hospital Name: ________________________________ 
City and State: __________________________________________ 
Country: _______________________________________________ 
 
EXPLANT INFORMATION 
Date of Explant/Autopsy: _____/_____/_____ 
Explanting Physician: _____________________________________ 
Name of Hospital: ________________________________________ 
Address: ________________________________________________ 
City and State: ___________________________________________ 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan 
10151194DOC
Version 1F
Page 138 of 200
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Country: ________________________________________________
Telephone: (  )_________________________________________
REASON FOR EXPLANT
________________________________________________________
________________________________________________________
 Planned Surgical Conversion
 Emergent Conversion
 Autopsy Date of Death: ____/____/____
Remarks about procedure:
Evidence of inflammation Yes No
Comments:_____________________________________
Thrombosis present in the seal zones Yes No
Comments:_____________________________________
Calcification present in the seal zones Yes No
Comments:_____________________________________
How well was the device attached to the patient’s tissue?
Proximally: Comes out easily from aortic vessel
 Appears firmly attached to aortic vessel
Mid body: Comes out easily from aneurysm contents
 Appears firmly attached to aneurysm contents

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan 
10151194DOC
Version 1F
Page 139 of 200
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Comments ____________________________________________________________________
Successful Surgical Conversion:  Yes  No
Patient Outcome:  Alive  Expired
DEVICE
CATALOG NUMBER
LOT NUMBER
FORM COMPLETED BY:________________________TITLE_________________
Additional Comments

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 140 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
RECORD OF DISCLOSURE OF HEALTH INFORMATION FOR PUBLIC HEALTH PURPOSES 
To Custodian of Patient Information: Federal privacy standards issued by the Department of 
Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 
1996 (HIPAA) require providers to record and, upon patient request, account for disclosures of 
patient information for public health purposes (except where disclosed pursuant to patient 
authorization or as part of a limited data set) (45 C.F.R. § 164.528(a)). This Record of Disclosure may 
be appended to the medical record to facilitate an accounting of disclosures.   
 
The information you are providing to Medtronic Vascular as described below, is necessary for 
Medtronic Vascular to meet our government obligations regarding safety, effectiveness and quality, 
and is a public health disclosure under Section 164.512(b)(1)(iii) of the HIPAA Privacy Rule. 
 
Date of Disclosure: 
Recipient and Contact Information: 
Medtronic Vascular, Inc.  
Quality Assurance Department  
3576 Unocal Place  
Santa Rosa, California 95403 
707-591-7672 
 
Description of Patient Information Disclosed: 
Examples of descriptions to be written here include: 
• 
Information regarding the functioning of the patient’s Valiant Stent Graft 
• 
Implant Operative Report, the Explant Operative Report, and surveillance radiology reports 
 
Purpose of Disclosure: 
The following language can be used on all Records of Disclosures: 
“For public health activities and purposes under Section 164.512(b)(1)(iii) of the HIPAA Privacy Rule, i.e. 
activities related to the quality, safety or effectiveness of FDA-regulated products or activities for which 
[Medtronic/Medtronic business unit] is responsible.” 
 

Evaluation of Valiant Mona LSA Clinical 
Investigation Plan  
 
10151194DOC 
Version 1F 
Page 141 of 200 
 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
APPENDIX I - CMS STUDY CRITERIA 
Medicare beneficiaries may be affected by the device because in 2013 more than 63% of 
TEVAR cases were performed in Medicare beneficiaries, and 59% of claims with principal 
TAA diagnoses involve patients age 65 or older. Study results are expected to be 
generalizable within the Medicare beneficiary population based on the prevalence of TAA in 
patients age 65 and older. 
 
All IRBs should comply with 45 CFR part 46. 
 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 142 of 200 
plate 
e 
. 
 
 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 143 of 200 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 144 of 200 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 145 of 200 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 146 of 200 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 147 of 200 
 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 148 of 200 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 149 of 200 

Evaluation of Valiant Mona LSA Clinical Investigation Plan  
 
 
10151194DOC 
Version 1F 
 
 
Page 150 of 200 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template