Disclaimer Of Warranty - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
•
If a new endoleak or increase in AAA size is observed by spiral CT, adjunctive studies such as
CDUS, 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.
•
If a new endoleak or increase in AAA size is observed by CDUS, a spiral CT with contrast might
be helpful in further evaluating the stent graft and the aneurysm.
•
Spiral CT without contrast, MRI or MRA may be considered in select patients that cannot tolerate
contrast media or have renal function impairment. For centers with appropriate expertise,
gadolinium or CO angiography can be considered in patients with renal function impairment
2
requiring angiographic assessment.
9.9.8. Treatment Considerations
Additional endovascular repair or open surgical aneurysm repair should be considered for patients with
evidence of suboptimal stent graft fixation, proximal endoleak, distal endoleak, junction endoleak,
unknown origin of persistent perigraft flow, or increase in AAA size > 5 mm.
9.9.9. Patient Information
Patient follow-up should be individualized to meet patient specific needs. However, imaging should be
scheduled based on the physician's clinical assessment of the patient pre- and post-discharge.

Disclaimer of Warranty

ALTHOUGH THE MEDTRONIC VASCULAR ENDURANT STENT GRAFT AND DELIVERY SYSTEM,
HEREAFTER REFERRED TO AS THE 'PRODUCT', HAS BEEN MANUFACTURED UNDER
CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC, INC., MEDTRONIC VASCULAR, INC. AND
THEIR RESPECTIVE AFFILIATES, (COLLECTIVELY "MEDTRONIC") HAVE NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS
ALL WARRANTIES, BOTH EXPRESSED AND IMPLIED, WITH RESPECT TO THE PRODUCT,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY
FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES
CAUSED BY ANY USE, DEFECT, FAILURE OR MALFUNCTION OF THE PRODUCT, WHETHER A
CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE.
NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PRODUCT.
The exclusions and limitations set out above are not intended to, and should not be construed so as to
contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is
held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the
validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and
obligations shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular
part or term held to be invalid.
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