Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals.
Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.
This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Pump thrombosis
Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.
All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.
Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.
The FDA does not recommend the elective removal of properly functioning systems.
“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.
Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.
If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.
For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.
The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.