Medtronic warns on HeartWare HVAD again

Sep 23, 2023

December 2, 2022 By Sean Whooley

The notice alerts healthcare professionals to safety information related to the controller driveline cover of the HeartWare ventricular assist device (HVAD). Over time, the driveline cover may become hardened. This could create difficulty or the inability to slide the cover back to access the driveline controller connector.

Delayed access to the connector may result in patient harm from a prolonged pump stop, according to the notice. Medtronic attributed the issue to plasticizer loss, which environmental factors may accelerate. Plasticizer keeps the driveline cover material soft and malleable.

Medtronic received 33 complaints of a hardened and/or stuck driveline cover between Jan. 3, 2017, and Sept. 15, 2022. The issue occurred after multiple years of use in the observed complaints. In all 33 events, users reported the driveline cover as either difficult to remove or unable to be manipulated by hand.

In 25 of the 33 events, users reported negligible or no patient harm. Four patients who observed a hardened driveline cover were hospitalized for unrelated reasons. In the remaining four events, a routine clinic visit led to the observation of a hardened driveline cover. Those patients were hospitalized to service and remove the driveline cover.

Medtronic attributed no critical harm or deaths to the issue.

Medtronic stopped sales of the HVAD in June 2021 as a result of mounting issues with the platform.

The decision came in light of several clinical comparisons indicating a higher frequency of neurological adverse events. That included stroke and mortality.

In February 2021, the company recalled the device after 855 complaints and eight injuries related to an issue with its ports. Medtronic reported 12 deaths among implanted patients in that recall, although three weren’t related to that specific issue.

The company also recalled instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. That recall included 130,716 devices in the U.S. distributed from March 2006 to the present (Feb. 26, 2021), with one death and 64 injuries reported.

Medtronic’s Feb. 26 recall also covered problems associated with HeartWare controller ports that the FDA announced in April 2021. The agency reported 12 deaths, 855 complaints and eight reports of injuries — figures that the company disputed.

In December 2020, Medtronic recalled its HeartWare HVAD pump implant kit because the device may fail to start, restart, or delay restarting after the pump was stopped. The FDA confirmed that recall in March, reporting with it two related deaths.

Earlier this year, the company recalled the HVAD batteries due to welding defects causing failure. In August, the FDA issued a Class I recall for Medtronic HVAD batteries due to electrical faults causing them to fail unexpectedly.

Filed Under: Cardiac Implants, Cardiovascular, Featured, Implants, Recalls, Regulatory/Compliance, Structural Heart Tagged With: Medtronic