On-X Chord-X Series User manual

On-X®Chord-X™Pre-Measured Loops
For Mitral Chordal Replacement
ePTFE Nonabsorbable Monofilament Suture, U.S.P. with PTFE Pledgets
On-X®Chord-X™Suture System
For Mitral Chordal Replacement
ePTFE Nonabsorbable Monofilament Suture, U.S.P. with PTFE Pledgets
Mode d’emploi - Français
FIL DE SUTURE en ePTFE Chord-X™
Gebrauchsanleitung - Deutsch
Chord-X™ePTFE-NAHTMATERIAL
Instrucciones de uso - Español
SUTURA DE ePTFE Chord-X™
Istruzioni per l’uso - Italiano
FILO DA SUTURA Chord-X™ePTFE
Instruções de utilização - Português
SUTURA EM ePTFE Chord-X™
Gebruiksaanwijzing - Dutch
Chord-X™ePTFE HECHTDRAAD
取扱説明書 - 日本語
Chord-X™ePTFE 縫合糸]
Instructions for Use

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TABLE OF CONTENTS
1. DESCRIPTION ................................................................................................. 4
2. INDICATIONS.................................................................................................. 5
3. CONTRAINDICATIONS ................................................................................... 5
4. WARNINGS..................................................................................................... 5
5. PRECAUTIONS................................................................................................ 5
6. RECOMMENDED TECHNIQUES ..................................................................... 7
6.1. Determine Loop Length..................................................................................7
6.2. Unpack Chord-X™ Prostheses from the Base-Plate........................................7
6.3. Removing Extra Loops ....................................................................................7
6.4. Papillary Suture Placement..............................................................................8
6.5. Leaflet Loop Placement ..................................................................................8
6.6. Final Procedures..............................................................................................9
6.7. References.....................................................................................................10
7. ADVERSE REACTIONS.................................................................................. 10
8. HOW SUPPLIED ............................................................................................ 11
9. DEFINITIONS ................................................................................................ 12
FIGURES ............................................................................................................. 81

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INSTRUCTIONS FOR USE
On-X®Chord-X™Pre-Measured Loops
On-X®Chord-X™Suture System
For Mitral Chordal Replacement
ePTFE Nonabsorbable Monofilament Suture, U.S.P. with PTFE Pledgets
1. DESCRIPTION
Chord-X™Pre-Measured Loops and Chord-X™Suture System for Mitral
Chordal Replacement is an artificial chordal replacement prosthesis
configured from nonabsorbable, monofilament suture manufactured from
expanded polytetrafluoroethylene (ePTFE). The ePTFE Suture has been
expanded to produce a porous microstructure which is approximately 50%
air by volume. The suture is undyed and contains no additives. The Chord-X™
Pre-Measured Loops and the Chord-X™Suture System for Mitral Chordal
Replacement prostheses have various product configurations comprised of
different suture diameter, loop length and needle configurations.
(See How Supplied)
The Chord-X™Pre-Measured Loops and Chord-X™Suture System prosthe-
ses are offered: (1) configured with pre-measured, pre-knotted ePTFE suture
loops (See Figure 1) and (2) configured with ePTFE suture strands with no
pre-tied knots allowing the surgeon to adjust and create artificial loops of a
customizable length. (See Figure 2)
Both the Chord-X™Pre-Measured Loops and the Chord-X™Suture System
prostheses come equipped with double-armed taper point needles
attached. Each prosthesis has 2 PTFE pledgets for papillary attachment. The
Chord-X™Pre-Measured Loops prosthesis features 3 chordal suture loops
for the leaflet, complete with needles and pre-tied knots, and 1 suture pair
with an attached pledget for the papillary muscle. The Chord-X™Suture
System prosthesis version features 3 pairs of chordal suture strands for the
leaflet and 1 pair of suture strands with an attached pledget for the papillary
muscle. Each prosthesis is positioned on a series of base-plates for suture
management. The base-plates protect the suture from getting kinked, bent
or otherwise damaged. If fewer chordal sutures are desired, excess segments
can be removed without jeopardizing the rest of the prosthesis.

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2. INDICATIONS
Chord-X™Pre-Measured Loops and Chord-X™Suture System for Mitral
Chordal Replacement are indicated for the repair or replacement of chordae
tendinae.
3. CONTRAINDICATIONS
This device is contraindicated for use in ophthalmic surgery, microsurgery,
and peripheral neural tissue.
4. WARNINGS
The replacement of chordae tendinae requires accurate sizing to ensure
satisfactory functioning of the valve mechanism post repair or replacement.
Chordae tendinae replaced with sutures that are either too long or too short
can result in failure to correct valvular incompetence. See the Recommended
Techniques section for determining correct length.
Caution and surgical judgment is necessary when considering the use of
this product in the setting of infectious endocarditis. The surgeon must
be aware that prosthetic material may become infected in the presence
of infectious endocarditis. Use in the presence of infectious endocarditis
can result in failure of the valve repair.
The prosthesis has been sterilized using ethylene oxide. Do not re-
sterilize.
Potential tissue in-growth of the Chord-X™Pre-Measured Loops or the
Chord-X™Suture System for Mitral Chordal Replacement made of ePTFE
Nonabsorbable Monofilament suture and/or the pledgets made of PTFE
felt may result in the attachment of the suture to the tissue it penetrates.
Such attachment could make removal of the Chord-X™Pre-Measured
Loops or Chord-X™Suture System sutures made of ePTFE Nonabsorbable
Monofilament suture difficult.
5. PRECAUTIONS
Successful use of this device requires appropriate training and experience in
cardiac surgical techniques including mitral valve repair.