`
`LJIJBEJHJ Remy/2d
`
`Appearance of the Sheath Upon Removal
`
`Some curvature of the sheath
`
`may be present
`
`
`
`
`Ripples along the seam are normal
`
`An open tip and seam are to be
`expected. It is important to remember
`throu h the rocedure to
`
`Previous generation device used for illustration
`
`
`
`Page 123 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 124 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`”/CMI-“i' CLI‘EH' Piyl'lU"?;lt|Ufl
`
`
`If Not Careful During Wire Exchange, Crossing and THV Positioning,
`Ventricular Perforation Could Occur
`
`
`
`_ Click Above to Play Video '
`
`
`
`
`
`
`
`
`
`F .
`‘
`
`-
`,
`limp
`ii Hi
`‘ l1] '
`
`
`
`
`Centered
`on
`Flex Tip
`
`,
`,
`THV P°5|t|°n
`before
`retrieving
`system and
`sheath as
`
`single unit
`
`‘ a
`
`NOTE:
`
`Crimped THV aligned on
`balloon is larger than
`crimped THV off balloon.
`Take care if deciding to
`retrieve.
`
`NOTE:
`Do not force the THV into
`the sheath. If resistance is
`felt, the THV may be caught
`on the sheath tip. Stop,
`advance THV past the
`sheath tip and ensure THV is
`centered on the Flex Tip.
`Rotate the delivery system
`before trying again.
`
`NOTE:
`
`Retrievability is based on
`preclinical testing
`
`
`7*",ng .
`
`.
`
`~
`
`(_
`
`P.“
`
`Completely Unflexed
`
`.
`
`- —‘>_
`
`A
`
`Q. P u'__
`
`I
`
`
`
`Loss of Capture During Rapid Pacing
`
`NWT—TVWWHHHH
`
`160
`
`, 140
`
`140
`
`"‘°"
`
`
`120
`120
`100
`1|
`
`fll-Ili_l
`“L-
`
`
`
`JI‘L‘Z
`
`.ax-N w
`
`«mu-n. w
`
`-2 I' u Ix NJ
`
`-' I' <4 _n w
`
`r a 3. AM
`
`
`
`
`
`Page 128 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 129 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`Page 130 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`THV Malposition: Egsajjgpl; 9:, 0/,
`
`
`
`
`*-
`
`THV Malposition
`
`Deployed THV too aortic
`
`Severe central and paravalvular regurgitation was created due to THV malpositioning
`
`
`
`“No testing has been performed to determine THV long-term durability in this configuration
`Previous eneration device used for illustration
`g
`
`-'-"‘:
`I! N;
`
`
`
`Page 132 of 172
`
`Edwards Lifesciences v. Boston Scientific Scimed
` IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2034 - Part 11
` PROTECTIVE ORDER MATERIAL
`
`
`
`AUi‘ii 9 Ti: / :iilUU
`
`
`
`122qu
`
`. J
`
`Possible Reasons THV Could Embolize into Aorta During THV Deployment
`
`Click Above to Play Video ‘
`
`
`Previous generation device used for illustration
`
`
`
`.J
`J
`Aorta J-J / :mrm 221519“
`
`
`
`y—’
`
`!
`
`‘.
`
`_.
`
`l
`
`
`
`Transapical procedure used for illustration
`
`
`
`Possible Reasons for
`
`Ventricular Embolization
`
`
`
`Ventricular Embolization
`
`Management
`
`Do not remove the wire.
`
`Maintain wire position.
`
`Consider CPB and surgical
`intervention
`
`Previous generation device used for illustration
`
`
`
`
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