Fridley, Minnesota–based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged.
Medtronic found a malfunction when inspecting the three removed pumps, which were manufactured between December 2017 and May 2018, the company said in an Urgent Medical Device Correction notification signed by Mechanical Circulatory Support Quality and Regulatory Affairs VP Gail Schroeder.
“Wear marks indicated that the impeller was rotating non-concentrically and contacting the center post of the pump,” Medtronic said in the April 27 notification. “The ongoing investigation suggests this was caused by a weld defect that allowed moisture into the center post and corroded the magnets that keep the impeller rotating concentrically.”
Medtronic is working to determine which HVAD pumps may be affected. In the meantime, the device manufacturer is warning healthcare providers of the potential danger and of signs that a device may be failing, including:
- Abnormal pump sounds such as grinding or excess vibration
- Transient power spikes on the log files and high watt alarms
- Elevated lactate dehydrogenase (LDH)
- Low motor speed resulting in low perfusion
The FDA reiterated that it does not recommend elective removal of properly functioning HVAD systems because “the risks associated with explant outweigh the potential benefits.”
“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 FDA said.
Medtronic pulled the left ventricular assist device (LVAD) from the market in June 2021 following patient deaths, injuries and Class I recalls.