Abbott Tendyne TENDV-LP-29S, Instructions For Use Manual

Page: 26 / 284

IFU, TENDYNE TM Mitral Valve System Page 26 of 284
13. Disposal
Dispose of all packaging materials as appropriate.
Dispose of Delivery Systems, Loading Systems, Pad
Positioning Systems, Retrieval Systems, and other
components per standard solid biohazard waste
procedures.
14. Explanted Valve
An explanted valve may be placed into a suitable
histological fixative such as 10% neutral buffered
formalin or 2% glutaraldehyde and returned for analysis.
Contact Abbott to request an Explant Kit.
15. Patient Registration
A medical device registration form and return envelope
are included with each device. Complete the
identification card attached to the medical device
registration form and provide it to the patient. After
implantation, please complete all requested information
and return the original form to Abbott. Tracking by
manufacturers is mandatory in some countries. Please
disregard any request for patient information if this
contradicts your local legal or regulatory requirements
regarding patient privacy.
DISCLAIMER OF WARRANTY AND
LIMITATION OF REMEDY
Abbott Medical has exercised reasonable care in the
manufacture of this device; however, numerous factors
beyond Abbott Medical’s control can affect this device and
the results obtained from its use. ABBOTT MEDICAL,
THEREFORE, MAKES NO WARRANTIES REGARDING THIS
DEVICE AND EXPRESSLY DISCLAIMS ALL WARRANTIES,
WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR
OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. ABBOTT MEDICAL SHALL
NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY
INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE OR
EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM THE USE
OF THIS DEVICE. NO PERSON HAS ANY AUTHORITY TO
ASSUME ANY LIABILITY ON BEHALF OF ABBOTT MEDICAL
WITH RESPECT TO THE DEVICE OR TO MAKE ANY
GUARANTEE, REPRESENTATION, OR WARRANTY WITH
RESPECT TO THE DEVICE. The exclusions and limitations set
forth above are not intended to and should not be
construed so as to contravene mandatory provisions of
applicable law. If any 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.
Descriptions or specifications in any Abbott Medical
printed material are intended solely to generally
describe the device at the time of manufacture and do
not constitute any express warranties.
ABBOTT MEDICAL WILL NOT BE RESPONSIBLE FOR ANY
DIRECT, INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE, OR EXPENSE RESULTING FROM REUSE,
REPROCESSING, OR RE-STERILIZATION OF THIS DEVICE.
17. Intellectual Property
™ Indicates a trademark of the Abbott group of
companies.
‡ Indicates a third-party trademark, which is property of
its respective owner.
Pat. www.abbott.com/patents
© 2020 Abbott. All Rights Reserved.