Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart

Starting date:
June 24, 2021
Posting date:
June 25, 2021
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information, Product Safety, Medical Devices
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-75905

Last updated:

Audience

Healthcare professionals in hospitals including cardiothoracic surgeons, intensive care physicians, critical care nurses, and others who use Heartware Ventricular Assist Device (HVADTM) System.

Key messages

  • The Medtronic HVADTM System has been recalled due to an increased risk of neurological adverse events and mortality, as well as complaints that the internal pump may experience a delay or fail to restart.
  • Medtronic is communicating additional instructions as a follow-up to a Recall Notice posted on June 9, 2021.
  • Healthcare professionals are advised to:
    • Immediately stop new implants of the Medtronic HVADTM System and consider using available alternative devices.
    • Continue following best clinical practices and manage patients implanted with the HVADTM pump according to the recommendations in the Instructions for Use (IFU), including closely managing blood pressure and International Normalized Ratio (INR).
    • Continue to use Autologs™ and HVADTM Logs to better understand pump performance and support clinical decision making.
    • Inform patients to continue normal use of the HVAD™ System peripherals such as Pioneer controllers, batteries, AC/DC adapters, and carrying case, and to contact their clinic for replacement as needed.
  • Prophylactic explant of the HVADTM System is not recommended.
  • Health Canada will continue to monitor the situation, and will take appropriate and timely action should new information become available.

   

Issue

On June 3, 2021, the Medtronic HVADTM System was recalled due to an increase in neurological adverse events and mortality, as well as a potential for the internal pump of the Medtronic HVADTM System to delay or fail to restart. Medtronic is now communicating additional instructions as a follow-up to a Recall Notice posted on June 9, 2021.

Products affected

Medtronic HeartWare Ventricular Assist Device (HVAD™) System, model 1104, more than 10 lot numbers, contact the manufacturer (see details below) for additional information.

Background Information

The HVADTM System is a Left Ventricular Assist Device (LVAD) that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure. The HVADTM System was authorized to be used as a bridge to cardiac transplantation in eligible patients.

The Medtronic HVADTM System was recalled on June 3, 2021, due to a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events and mortality with the system when compared to other commercially available durable LVADs. Considering these findings and given the availability of alternative devices, Medtronic has decided to stop the distribution and sale of the HVADTM System.

In addition, in December 2020, Medtronic issued an Urgent Medical Device Communication informing physicians of an issue where the internal pump of the HVADTM System may experience a delay or fail to restart. The communication explained that a subset of HVADTM System included an internal pump component from three specific lots that increased the risk of restart failure.

Between January 2009 and April 22, 2021, Medtronic received a total of 106 complaints globally involving a delay or failure to restart the internal pump of the HVADTM System, including 14 patient deaths and 13 cases where an explant was necessary. Aside from the three specific lots that were recalled in December 2020, Medtronic has not been able to determine the root cause for other restarting failures.

Who is affected

Information for consumers

The HVADTM System helps the heart pump blood to the rest of the body. It is used as a bridge to heart transplants in eligible patients.

The Medtronic HVADTM System was recalled because it could cause serious harm, including harm to the patient’s brain and nervous system, and death. The Medtronic HVADTM System was also recalled because of complaints that the internal pump may delay or fail to restart. The distribution and sale of the device has stopped. Patients who currently have the HVADTM System should continue to have regular check-ups with their healthcare professionals, and follow their advice and directions.

Patients are reminded to never disconnect their HVADTM pump from two power sources at the same time, and to always have a back-up controller and fully charged spare batteries available. The patients should also continue with the normal use of the device components, and contact their clinic for replacement items such as Pioneer controllers, batteries, AC/DC adapters and carrying case.

Patients should contact their healthcare professional for questions about the use and safety of their device. It is not recommended that surgeons remove the HVADTM System.

Information for healthcare professionals

Healthcare professionals are advised to:

  • Immediately stop new implants of the Medtronic HVADTM System and consider using available alternative devices.
  • Continue following best clinical practices and manage patients implanted with the HVADTM pump according to the recommendations in the IFU, including closely managing blood pressure and International Normalized Ratio (INR).
  • Continue to use Autologs™ and HVADTM Logs to better understand pump performance and support clinical decision making.
  • Inform patients to continue normal use of the HVAD™ System peripherals such as Pioneer controllers, batteries, AC/DC adapters, and carrying case, and to contact their clinic for replacement as needed.

Prophylactic explant of the HVADTM System is not recommended.

Action taken by Health Canada

Health Canada is communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website.

Health Canada will continue to monitor safety information involving HVADTM Systems, as it does for all health products on the Canadian market, to identify and assess potential harm. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents.  Any case of serious or unexpected adverse incident associated with the use of HVADTM System should be reported to Medtronic Canada ULC or Health Canada.

Any suspected adverse incident can be reported to:

Medtronic Canada ULC
99 Hereford Street
Brampton, ON, L6Y 0R3
Phone: 800-268-5346

To correct your mailing address or fax number, contact Medtronic Canada ULC .

The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Enforcement Branch
E-mail: hc.hpce-cpsal.sc@canada.ca

Sincerely,

Original signed by

Isabelle Gerges
Director, Quality and Regulatory Affairs
Medtronic Canada ULC