Patient Selection And Treatment; Individualization Of Treatment; Patient Counseling Information - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
Table 1. Potential Risks Associated with Use of the Endurant Stent Graft System
■ Access failure
■ Allergic reaction (to contrast,
anti-platelet therapy, stent graft
material)
■ Anastomotic false aneurysm
■ Anemia
■ Anesthesia-related complica-
tions
■ Aneurysm expansion
■ Aneurysm rupture
■ Angina
■ Aortic vessel rupture
■ Aortoenteric fistula
■ Arrhythmia
■ Arteriovenous fistula
■ Atelectasis
■ Atherosclerotic ulcer
■ Bowel ischemia
■ Bowel necrosis
■ Bowel obstruction
■ Branch vessel occlusion
■ Buttock claudication
■ Cardiac tamponade
■ Catheter breakage
■ Cerebrovascular accident
■ Change in mental status
■ Coagulopathy
■ Congestive heart failure
■ Contrast toxicity
■ Conversion to surgical repair
■ Damage to the vessel which may
require a conversion to open repair
■ Death
■ Dehiscence
■ Deployment failures

6. Patient Selection and Treatment

6.1. Individualization of Treatment

Each Endurant stent graft component must be ordered in a size appropriate to fit the patient's anatomy.
Proper sizing of the device is the responsibility of the physician. The aortic stent graft component should
be oversized approximately 10% to 20% from the vessel inner diameter, and the Endurant stent graft
components cover aortic diameters ranging from 19 mm to 32 mm. The recommended overall length of
multiple deployed in situ assembled modular components of the Endurant Stent Graft System should
extend from the lowest renal artery to just above the internal iliac (hypogastric) artery bifurcation. All lengths
and diameters of the stent graft components necessary to complete the procedure should be available to
the physician, especially when pre-operative case planning measurements (treatment diameters/lengths)
are not certain. Using this approach allows for greater intraoperative flexibility to achieve optimal
procedural outcomes.
Medtronic Vascular may consult with physicians in their efforts to determine proper stent graft component
dimensions based on the physician's assessment of the patient's anatomical measurements. The risks
and benefits previously described in Section 4.3 should be carefully considered for each patient before
use of the Endurant Stent Graft System.
Patient selection factors to be assessed should include:
•
Patient's age and life expectancy
•
Co-morbidities (e.g. cardiac, pulmonary or renal insufficiency prior to surgery)
•
Patient morphologic suitability for endovascular repair
•
The risk of aneurysm rupture balanced against the risk of treatment with the Endurant Stent Graft
System
Note: Due to the nature of the design and the flexibility of the Endurant Stent Graft System, the overall
length of each stent graft component may be shorter when deployed than expected due to compression
during deployment or tortuous anatomy.
Caution: Vessel over-distension and damage may be caused by excessive oversizing of the stent graft
in relation to the diameter of the blood vessel.
Caution: Insufficient oversizing may increase the risk of endoleaks.
Caution: Excessive oversizing of the bifurcated stent graft may limit the expansion of the device and cause
stents and fabric in the aortic body between the flow divider and the proximal sealing stent to fold in towards
the lumen.
6.2. Specific Patient Populations
The safety and effectiveness of the Endurant Stent Graft System for the treatment of the abdominal aortic
aneurysms (AAA) has not been evaluated in patients:
•
With aneurysms pending rupture
•
With connective tissue disorder
•
With hypercoagulability
•
With mesenteric artery occlusive disease
•
With ilio-femoral, thoracic or inflammatory aneurysms
•
With juxtarenal AAA
•
With pararenal AAA
•
With suprarenal or thoraco-abdominal aneurysms
•
Who are morbidly obese
•
Pregnant or nursing
•
Less than 18 years old
•
With less than one year life expectancy

7. Patient Counseling Information

The physician should review the following risks and benefits when counseling the patient about this
endovascular device and procedure:
•
Risks and benefits related to open surgical repair.
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■ Device malfunction
■ Dissection, perforation, or rupture
of the aortic vessel & surrounding
vasculature
■ Embolism
■ Endoleaks
■ Excessive or inappropriate radia-
tion exposure
■ Extrusion/erosion
■ Failure to deliver the stent graft
■ Fem-Fem bypass occlusion
■ Femoral neuropathy
■ Fever
■ Gastrointestinal bleeding
■ Genitourinary complications
■ Hematoma
■ Hypotension/hypertension
■ Ileus
■ Infection
■ Intramural hematoma
■ Lower limb edema
■ Loss of stent graft integrity
■ Loss of stent graft patency
■ Lymphocele/lymph fistula
■ Myocardial infarction
■ Neck enlargement (aneurysmal)
■ Neoplasm
■ Nerve injury
■ Pain/reaction at catheter insertion
site
■ Paraplegia
■ Pericarditis
■ Peripheral ischemia
■ Peripheral nerve injury
■ Pleural effusion
■ Pneumonia
■ Pneumothorax
■ Post-implant syndrome
■ Post-procedural bleeding
■ Procedural bleeding
■ Pseudoaneurysm
■ Pulmonary edema
■ Pulmonary embolism
■ Renal failure
■ Renal insufficiency
■ Respiratory depression or
failure
■ Retroperitoneal bleeding
■ Sepsis
■ Seroma
■ Sexual dysfunction
■ Shock
■ Spinal neurological deficit
■ Stenosis
■ Stent graft dilatation
■ Stent graft infection
■ Stent graft kinking
■ Stent graft migration
■ Stent graft misplacement
■ Stent graft rupture
■ Stent graft thrombosis
■ Transient-ischemic attack
■ Vascular trauma
■ Vessel occlusion
■ Wound infection
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