HeartMate

Main information

  • Trade name:
  • HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory assist system inflow cannula, animal-derived
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory assist system inflow cannula, animal-derived
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217354
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217354

St Jude Medical Australia Pty Ltd - HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory

assist system inflow cannula, animal-derived

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

15/11/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Thoratec Corporation

6035 Stoneridge Drive

Pleasanton, CA, 94588

United States Of America

Products

1. HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory assist system inflow cannula,

animal-derived

Product Type

Single Device Product

Effective date

15/11/2013

GMDN

61749 Implantable ventricular circulatory assist system inflow cannula, animal-derived

Functional description

The sealed inflow conduit of the pump is attached to the apex of the left ventricle and the pump sealed

outflow graft is connected to the ascending aorta. The sealed inflow conduit and outflow elbows have a

textured titanium microsphere surface.

Intended purpose

Intended as a component of a ventricular circulatory assist system for haemodynamic support to patients

with end stage refactory left ventricular heart failure.

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:33:50 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

There are no news related to this product.