Thoratec HeartMate 3 Coring Tool User manual

Thoratec Corporation
HEARTMATE 3™ CORING TOOL
Instructions for Use

United States & Canada
Thoratec Corporation
(International Headquarters)
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Telephone: [phone]
Fax: [phone]
Authorized EU Representative
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
Telephone: [phone]
24-Hour Number: [phone]
Thoratec Corporation continually strives to provide the
highest quality of products for mechanical circulatory
support. Specifications may change without notice.
Thoratec and the Thoratec logo are registered trademarks.
HeartMate 3 Coring Tool is a trademark of Thoratec
Corporation.
Tyvek is a registered trademark of E. I. duPont de
Nemours and Company or its affiliates.
©2018 Thoratec Corporation.
Document: 10006217.D Publication Date:
03/2019

HeartMate 3 Coring Tool Instructions for Use 3
INTRODUCTION
Preface
This manual contains information needed to properly and
safely use the HeartMate 3 Coring Tool. New users should
read this document in its entirety before using the Coring
Tool. For experienced practitioners, this manual may serve
as a reference.
As with all prescription medical devices, clinical procedures
should be conducted under the direction of the prescribing
physician. Use of the HeartMate 3 Coring Tool should be
performed only by physicians who have received Thoratec
training.
Understanding Warnings and Cautions
In this manual, warnings and cautions that are relevant to a
specific procedure or piece of equipment appear at the start
of each applicable section.
Warnings refer to actions or hazardous conditions that could
cause serious injury or death if not avoided. Ignoring a
warning can cause sudden and serious injury, life-
threatening harm, or death for the user or patient.
Cautions refer to actions or potentially unsafe conditions that
may cause injury to a patient or user, damage the
equipment, or affect how the system works. Ignoring a
caution can cause the patient or user injury, or result in
equipment failure or sub-optimal system operation. Although
important for maximum safety and optimal system function,
usually cautions do not refer to life-threatening risks.
WARNING !
Warnings appear in the manual in this format.
CAUTION !
Cautions appear in the manual in this format.

HeartMate 3 Coring Tool Instructions for Use 4
OVERVIEW
The HeartMate 3 Coring Tool Instructions for Use (IFU)
provides important information on coring the left ventricle
and removing cored tissue. For additional information
regarding the HeartMate 3 Left Ventricular Assist System,
refer to the HeartMate 3 Left Ventricular Assist System
Instructions for Use.
Package Contents
The HeartMate 3 Coring Tool package contains
• HeartMate 3 Coring Tool
• Instructions for Use for HeartMate 3 Coring Tool
The HeartMate 3 Coring Tool is supplied sterile and for single
use only. Store components in
a cool, dry place. The system is
packaged for safe transportation and effective use in an
operating room under sterile conditions.
Description
The HeartMate 3 Coring Tool consists of a circular blade
attached to a plastic handle for a comfortable grip. A grey
line is marked on the plastic handle to aid in counting
rotations of the Coring Tool while coring. A helix is present
within the blade to retain the cored tissue. A guide pin is
present at the center of the helix to aid in centering of the
Coring Tool with respect to a HeartMate Apical Cuff. The
helix is attached to a center rod that is spring loaded. The
locking tabs hold the center rod in place when locked, and
are pinched to be released and retract the helix and pull it to
the blade.
Locking Tabs
Blade
Guide Pin
Helix

HeartMate 3 Coring Tool Instructions for Use 5
WARNING !
• A thorough understanding of the technical principles,
clinical applications, and risks
associated with left
ventricular support is necessary before using the
HeartMate 3 Coring Tool
system. Read this entire
manual before attempting implantation of the Left
Ventricular Assist
Device or before caring for
HeartMate 3 patients. Completion of the Thoratec
Corporation HeartMate 3 Surgical Training Program
and the HeartMate 3 Coring Tool Surgical Training
Program are also required prior to use.
• Understanding the operating and safety aspects of the
HeartMate 3 Coring Tool is critical for safe and
successfuluse.
•Do
not modify this device without authorization from
Thoratec Corporation.
• HeartMate 3 Coring Tool is compatible only with the
HeartMate 3 Left
Ventricular Assist System.
•Do
not use the HeartMate 3 Coring Tool if the sterile
packaging is damaged or open.
• Ensure the HeartMate 3 Coring Tool is not damaged
prior to use.
•Do
not use the HeartMate 3 Coring Tool if it has been
dropped. The Coring Tool is for single use only. Do not
attempt to re-sterilize as this may damage the
device
and impair its functionality and/or degrade its safety.
•Do
not reuse any items. If any items are dropped they
cannot be flash sterilized and a new kit must be
opened.
• Only personnel using sterile technique should make
contact with the sterilized kit accessories.
•Do
not attempt to use the Coring Tool in ventricles with
wall thickness greater than 21mm. Use of the Coring
Tool in tissue greater than 21mm may result in
inadequate cored tissue and challenges removing the
Coring Tool from the ventricle.

HeartMate 3 Coring Tool Instructions for Use 6
CAUTION !
• Clinical procedures should be conducted under the
direction of the prescribing physician
(Authorized
Personnel) only.
•Donot try to repair the Coring Tool system
components. If components need service,
contact the
appropriate Thoratec personnel.
• Notify the appropriate Thoratec personnel if there is a
change in how the device works,
sounds, or feels.
•Do
not use the HeartMate 3 Coring Tool system after
the “Use by” date specified on the package
label.

HeartMate 3 Coring Tool Instructions for Use 7
Indications
For the HeartMate 3 Left Ventricular Assist System Indications
for Use, please refer to the HeartMate 3 Instructions for Use.
The HeartMate 3 Coring Tool is intended for use with the
HeartMate 3 Left Ventricular Assist System (LVAS). The
Coring Tool provides a means to resect a plug of
myocardium from the left ventricle, which allows for
HeartMate 3 inflow cannula insertion.
Contraindications
The use of the HeartMate 3 Coring Tool is contraindicated in
patients who are contraindicated for HeartMate 3 Left
Ventricular Assist System (LVAS) therapy.
Compatibility
The HeartMate 3 Coring Tool can be used with all
HeartMate 3 compatible Apical Cuffs. The HeartMate 3
Coring Tool should not be used with the HeartMate II LVAS.
Adverse Events
The following adverse events may be associated with the use
of the Coring Tool. Adverse events are listed in anticipated
decreasing order of frequency, except for death, which
appears first as it is a non-reversible complication:
•Death
• Bleeding (perioperative or late)
•Localinfection
•Localischemia
• Cardiac arrhythmia
•Stroke
• Peripheral thromboembolic event
• Neurologic dysfunction
•Hemolysis
•Sepsis

HeartMate 3 Coring Tool Instructions for Use 8
SURGICAL PROCEDURES
This section describes the preimplant, implant, and proce-
dures for the HeartMate 3 Coring Tool.
Equipment and Supplies Required for Implant
Thoratec-Supplied Equipment
• Included in this package:
• HeartMate 3 Coring Tool
• Supplied separately:
• HeartMate 3 Left Ventricular Assist System Implant Kit
• See the HeartMate 3 Left
Ventricular Assist System
Instructions for Use for detailed information
regarding this kit.
• HeartMate 3 Mini Apical Cuff kit (optional)
• See the HeartMate 3 Mini Apical Cuff Instructions
for Use for detailed information regarding this
kit.
Unpacking the Coring Tool
Thoratec Corporation ships the HeartMate 3 Coring Tool sys-
tem in a cardboard box. You will
need to remove the tray
from the cardboard box. The Coring Tool inner tray is sealed
by a Tyvek®
cover to maintain sterility.
CAUTION !
• The HeartMate 3 Coring Tool is supplied sterile and is
intended for single use only and should not be re-used
or re-sterilized.
•Do
not use sterile components if sterile packaging is
compromised. Contact Thoratec for Return Authoriza-
tion number.

HeartMate 3 Coring Tool Instructions for Use 9
Note: The operating room has several sterile fields. Use care
when unpacking these items, as all of them must be placed
in the sterile fields.
Unpacking the Coring Tool Tray
To unpack the Coring Tool from the tray:
1. Peel back and remove the cover from the main
packaging tray.
2. Remove the HeartMate 3 Coring Tool inner tray from
the main packaging tray. Place the HeartMate 3
Coring Tool inner tray in the sterile work area.
3. Peel back and remove the cover from the HeartMate 3
Coring Tool inner tray and remove the clear insert
covering the Coring Tool.
4. Avoid depressing the tabs on the Coring Tool during
removal from the packing tray.
5. Remove the HeartMate 3 Coring Tool from the tray
and place them in the sterile work area.
6. Remove the black blade cover immediately prior to
use of the Coring Tool.
WARNING !
•Do
not reuse any items. If any items are dropped, they
cannot be flash sterilized and a new kit must be
opened.
• Only personnel using sterile techniques should touch the
sterilized Coring Tool.
•Do
not use the device if it appears to be damaged in
any way.
CAUTION !
The cutting end of the Coring Tool is extremely sharp and
should be handled with care to
prevent injury.

HeartMate 3 Coring Tool Instructions for Use 10
DIRECTIONS FOR USE
Note: Prepare the patient and HeartMate 3 LVAS based on
instructions provided in the HeartMate 3 IFU. The Coring
Knife provided in the HeartMate 3 LVAS implant kit is not
required as the HeartMate 3 Coring Tool provided in this
package will be used to core the left ventricle.
Coring Procedure
The illustrated Turn-Pinch-Turn process on the Coring Tool
summarizes the three key steps involved in using the Heart-
Mate 3 Coring Tool. The steps are detailed in the section
below.
The Coring Tool may be used in a Core-Then-Sew or Sew-
Then-Core approach.
WARNING !
•Do
not attempt to use the Coring Tool in ventricles with
wall thickness greater than 21mm. Use of the Coring
Tool in tissue greater than 21mm may result in
inadequate cored tissue and challenges removing the
Coring Tool from the ventricle.
• It is important to remove the air in the ventricle to avoid
air escaping from the ventricle and causing air
embolism.
CAUTION !
Sharp instruments enter the left ventricle during this proce-
dure. Guide all sharp instruments with caution.
3

HeartMate 3 Coring Tool Instructions for Use 11
Sew-Then-Cut
1. Choose the implant location slightly anterior to
the apex, a few centimeters lateral to the left
anterior descending coronary artery.
2. Suture the HeartMate 3 Apical Cuff or
HeartMate 3 Mini Apical Cuff at the location
chosen above.
Note: Refer to the HeartMate 3 LVAS Instructions for Use for
Apical Cuff suturing approach and Mini Apical Cuff Instruc-
tions for Use for Mini Apical Cuff installation approaches.
3. Align and insert the guide pin of the
HeartMate 3 Coring Tool into the center of the
HeartMate 3 Apical Cuff or HeartMate 3 Mini
Apical Cuff.
4. Align the orientation of the Coring Tool
towards the mitral valve.
5. Advance the Coring Tool guide pin through
the myocardium until the helix is touching the
ventricular surface.
6. Turn the Coring Tool handle clockwise for
three turns to install the helix into the tissue.
CAUTION !
Avoid counter-clockwise rotation or oscillation of Coring
Tool while cutting as tissue may be released into the ventri-
cle.
3x

HeartMate 3 Coring Tool Instructions for Use 12
7. Align the Coring Tool handle so it is
perpendicular to the tissue.
8. Pinch the locking tabs on the back of the
Coring Tool to retract the helix and pull the
tissue to the blade.
CAUTION !
• Avoid rotating the center rod within the blade while
cutting tissue as this can result in tissue twisting or
release of cored tissue.
•Always retract the helix into the Coring Tool before
engaging the blade into the tissue. The helix may
damage the septum if the blade cores the tissue before
retracting the helix.
CAUTION !
Depressing the locking tabs may cause the helix to retract
with force. Maintain a grip on the locking tabs while
deflecting.

HeartMate 3 Coring Tool Instructions for Use 13
9. Turn the Coring Tool clockwise to core the
ventricle. Continue rotating until the white line
on the green center rod becomes visible and
the ventricle is completely cored. Loss of
rotation resistance is another indication that
the coring is completed.
Note: The blade should rotate about the stationary helix.
10. Pull to remove Coring Tool from the heart.
a. If resistance is felt while removing the
Coring Tool from the ventricle then the
tissue may not be fully cored.
b. Pull back the locking tabs until the white
line becomes visible while rotating the
Coring Tool blade clockwise to cut the
remaining tissue.
c. Always rotate the blade about the stable
helix.
Cut-Then-Sew
The Coring Tool may be used in a Cut-Then-Sew approach
by first creating the ventriculotomy described in steps 3
through 9 and then suturing the HeartMate 3 Apical Cuff to
the exterior of the ventricle.
CAUTION !
Once the helix is retracted into the Coring Tool, the sur-
geon should avoid re-engaging the center rod to the
blade until the Coring Tool is removed from the ventricle
as tissue may be released into the ventricle.

HeartMate 3 Coring Tool Instructions for Use 14
Removing and Inspecting the Cored Tissue
1. Align the white line on each of the locking tabs
to the black lines on the top edge of the Coring
Tool handle.
2. Push the locking tabs into the blade handle
until the tabs latch securely into the blade
handle. The locking tabs are locked by placing
a finger between the tabs and making sure
they are fully separated once engaged with the
tabs.
3. Uncoil cored tissue from the helix using tissue
forceps by rotating counter-clockwise.
Note: Avoid uncoiling the cored tissue by hand. Removal
should be completed using forceps to protect from disen-
gagement of the blade and injury to fingers.
CAUTION !
The helix will protrude from the center of the blade. Keep
hands away from the helix tip and blade.
Unlocked
Locked

HeartMate 3 Coring Tool Instructions for Use 15
SYMBOLS
Description of Labeling Symbols
General Symbols
SYMBOL DESCRIPTION
Manufacturer
Date of manufacture
Catalog Number
Serial Number
Batch Code (Lot Number)
European Conformity
Authorized representative in
the European community
Temperature Limitation
Sterilized using Ethylene
Oxide
Do not use if package
damaged
Do not reuse.
Do not resterilize
Peel Tab

HeartMate 3 Coring Tool Instructions for Use 16
Caution
Refer to instruction manual
Use by
Keep dry
Caution: US federal law
restricts this device to sale by
or on the order of a physician
SYMBOL DESCRIPTION