Thoratec HeartMate III, Instructions For Use Manual, Page: 263 / 458

Surgical Procedures 5
HeartMate III Left Ventricular Assist System Instructions for Use 5-55
Device Tracking and Reporting Requirements
The HeartMate III Left Ventricular Assist System is considered a life-sustaining medical device and
must be tracked per foreign regulatory agency regulations. Compliance is mandatory.
Accordingly, all device-tracking paperwork shipped with the device must be completed and
promptly returned to Thoratec Corporation. In addition, any device malfunctions must be
reported to Thoratec Corporation by the implanting center.
Device Explant
Explanting the Left Ventricular Assist Device
F
OR THIS TASK YOU NEED
:
• 1 CV major surgical set
• 1 HeartMate explant kit
T
O EXPLANT THE
L
EFT
V
ENTRICULAR
A
SSIST
D
EVICE
:
1. Expose the device and carefully dissect it free.
2. Place the patient on cardiopulmonary bypass and establish flow.
3. Disconnect power from the System Controller, and then disconnect the in-line connection to
stop pumping.
4. Cross-clamp the sealed Outflow Graft just distal to the bend relief and divide the graft.
5. Expose the Slide Lock mechanism and pull it radially to disengage the Pump from the
Apical Cuff.
6. Disengage the Pump from the ventricle.
7. Repair or plug the ventricle as necessary.
8. Dissect the Pump Cable between the device body and the abdominal wall.
9. Cut the Pump Cable and then remove the externalized portion.
WARNING !
There is a risk of embolism at the Left Ventricular Assist Device explant or reoperation if
manipulation of the Pump or Outflow Graft is performed prior to initiation of cardiopulmonary
bypass and stoppage of device pumping.
CAUTION !
The Driveline at explant is not sterile, and care must be taken to avoid contamination of the
sterile field. Sterile glove fingertips can be attached to the ends of the Driveline after it is cut
to minimize the risk of contact with the sterile field.