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Date: 2021-09-17 Category: Not Applicable State: Union Government Country: India

Alert_FSN-Medtronic Heartware HVAD

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Key Changes

  • The recall affects all HeartWare HVAD Systems distributed from August 30, 2016, to June 3, 2021. Approximately 4,620 devices are recalled in the U.S.
  • There is an increased risk of neurological adverse events and mortality associated with the internal pump of the HVAD System.
  • The internal pump may delay restarting or fail to restart, leading to death or serious patient harm, including stroke, heart attack, worsening heart failure, the need for additional procedures and hospitalizations.
  • Medtronic reports over 100 complaints involving a delay or failure to restart of the HVAD internal pump, which led to a total of 14 deaths and 13 pump removals.
  • Healthcare providers are advised to stop new implants of the HeartWare HVAD System and use an alternative commercial LVAD, such as the Abbott HeartMate 3 LVAD.
  • Unused HeartWare HVAD System components, including pump implant kits and accessories, outflow grafts, and driveline extension cables, should be returned to Medtronic.
  • For existing patients on HVAD support, the recommendation is not to remove already implanted HVAD devices unless the risks associated with keeping the device outweigh the potential benefits, which should be assessed on a case-by-case basis.
  • Medtronic has stopped the distribution and sale of the HeartWare HVAD System.

What it means

  • The Central Drugs Standard Control Organization (CDSCO) has issued a medical device alert regarding the HeartWare HVAD System manufactured by Medtronic.
  • Medtronic is stopping distribution and sale of the HeartWare HVAD System due to an increased risk of neurological adverse events, mortality, and potential failure to restart the internal pump.
  • The FDA has identified this as a Class I recall, the most serious type of recall, indicating that use of these devices may cause serious injuries or death.

Impact Analysis

Patients

  • Patients can find more information at www.Medtronic.com/HVADsafety.

Healthcare Providers

  • For “HVAD only” implanting centers, Medtronic is available to facilitate training on an alternative device, such as the Abbott HeartMate 3 LVAD. Medtronic will also work with these centers to develop a transition plan to an alternative LVAD.

Medtronic

  • Medtronic is working with centers to develop a transition plan to an alternative LVAD.

Hospitals and Clinics

  • Hospitals and clinics should consider training staff on the use of alternative LVAD devices.

Key Entities Referenced

Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for ensuring the safety, efficacy, and quality of drugs and medical devices. Medtronic: The manufacturer of the HeartWare HVAD System. HeartWare HVAD System: A ventricular assist device used as a bridge to cardiac transplants or as destination therapy for patients with end-stage left ventricular heart failure. FDA: The Food and Drug Administration, the regulatory agency in the United States responsible for the safety and effectiveness of medical devices. Abbott HeartMate 3 LVAD: An alternative commercial left ventricular assist device.
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