HeartWare VAD Linked to Fatal Adverse Events
Thomas J. Henry is currently investigating reports of serious injury and death in connection with HeartWare’s ventricular assist device (VAD).
Electrostatic discharge from the device’s external controller can result in device failure, leading to serious injury and death. Other complaints filed by consumers include reports of a loose driveline connector and reports of battery failure.
FDA ISSUES WARNING LETTER TO HEARTWARE
In June 2014, the U.S. Food and Drug Administration (FDA) issued a warning letter to HeartWare, claiming that the company failed to take appropriate measures in response to complaints concerning the VAD.
In the letter, the FDA cited 27 complaints related to the external controller. Four of these complaints involved cases of serious injury and two resulted in patient deaths.
According to the Manufacturer and User Facility Device Experience (MAUDE), however, more than 500 adverse events have been reported with 76 resulting in death.
HeartWare was given 15 days to respond to the FDA’s letter.
OTHER OBSERVATIONS CITED IN THE WARNING LETTER
- Failure to properly address issues related to electrostatic discharge
- Failure to take effective actions related to the loose driveline connector
- Failure to adequately implement procedures for corrective and preventative action related to battery failure
- Failure to properly maintain records of device investigation
- Failure to establish and maintain measures to validate the device design
- Failure to validate the computer software used with the device