CDSCO raises alert on Medtronic HeartWare HVAD System, physicians asked to cease new implants
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for Medtronic's HeartWare Ventricular Assist Device (HVAD) System, citing an increased risk of neurological adverse events and mortality associated with the internal pump.
The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.
The safety alert comes in line with a Field Safety Notice issued by India Medtronic Pvt. Ltd., Gurugram, Haryana, stating that Medtronic has stopped selling and distributing the HeartWare HVAD System due to the risk of neurological adverse events, death, and potential failure to restart.
Medtronic has stopped the distribution and sale of the HVADâ„¢ System as of June 3, 2021 and has notified physicians to cease new implants of the HVAD System and transition to an alternative commercially available left ventricular assist device (LVAD) for all future implants.
As per the field safety notice, Medtronic is stopping the distribution and sale of the Heartware HVAD System because:
i) There is an increased risk of neurological adverse events and mortality associated with the internal pump.
ii) If the internal pump stops, it may delay restarting or fail to restart.
Both problems may lead to death or serious patient harm, including stroke, heart attack, worsening heart failure, the need for additional procedures, and hospitalizations.
The field safety notice indicated that there is a growing body of observational clinical comparisons showing a higher frequency of neurological adverse events and mortality among HVAD System patients as compared to those who receive other commercially available durable left ventricular assist devices (LVAD).
Medtronic reports there are 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.
Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritise patient safety.
Further, according to the safety notification, the following people may be affected :
a) Health care providers using the Heartware HVAD System
b) Patients who have procedures with the Heartware HVAD System
In light of the foregoing, on June 3, 2021, Medtronic issued an Urgent Medical Device communication to health care providers recommending physicians:
• Stop new implants of the HeartWare HVAD System.
• Continue normal use of peripherals and contact Medtronic for replacement of peripheral components (for example: Controllers, batteries AC/DC Adapters, Carrying Case)
• Complete a Customer Confirmation Form and email to rs.cfqfca@medtronic.com (mailto:rs.cfqfca@medtronic.com)
Further, the communication offered several patient management recommendations, including:
For existing patients on HVAD support:
• Do not remove already implanted HVAD devices. Risks associated with removing the devices may outweigh the potential benefits. The decision regarding removal and exchange of the HVAD pump should be made on a case-by-case basis, considering the patient's clinical condition and surgical risks.
• Continue to follow instructions provided in the instructions for use (IFU) and adhere to current best clinical practices, including strict management of blood pressure and International Normalized Ratio (INR), and the use of system log files to support clinical decision making related to pump performance. Specific details about these clinical practises can be found in the Urgent Medical Device Communicatio (https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-devicenotice-june-2021.pdf)  (http://www.fda.gov/about-fda/website-policies/website-disclaimer)n
• Patients should continue normal use of the HVAD System peripherals (for example: Pioneer controllers, batteries, AC/DC adapters, and carrying case) consistent with the IFU and should contact their clinic for replacement as needed.
• Patients also should be reminded to never disconnect the pump from two power sources at the same time and to always have a back-up controller and fully charged spare batteries available.
For patients in need of LVAD placement
• Use an alternative commercial LVAD, such as the Abbott HeartMate 3 LVAD.
• If no alternative commercial LVAD is available for patients in urgent need, physicians and patient must complete a Patient Information form to acknowledge the risks of the Medtronic HVAD implant
• 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.
In continuation, on July 7, 2021, Medtronic issued a follow up Urgent Medical Device Communication to provide instructions for returning some HVAD inventory, including pump implant kits and accessories, outflow grafts, and driveline extension cables.
On August 10, 2021, Medtronic issued a letter to healthcare professionals to inform them that Medtronic will be issuing a separate communication about the decision to Halt HVAD Distribution to all Medtronic HVADâ„¢ patients.
In light of the foregoing, the CDSCO released a medical device alert advising consumers to take the following immediate actions:
• Field representatives may assist customers with the return of unused product (sold) and the timely return of the customer signed Customer Confirmation Form.
• Field representatives may assist customers with the timely return of the customer's signed Customer Confirmation Form.
• Other associated Corrective/Preventive Actions established in associated CAPA.
• Further, the firm is deploying a permanent corrective action to address the two issues described in the recall notice.
To view the official notice, click the link below:
