FDA Issues Warning Over HeartWare VAD
The U.S. Food and Drug Administration (FDA) has issued a warning letter to HeartWare, noting that the company has failed to properly verify corrective measures put in place after receiving complaints over its ventricular assist device (VAD).
Multiple Deaths Linked to HeartWare VAD
In a letter dated June 2, 2014, the FDA cites 27 complaints concerning controller failure. The regulator has linked the issue to two deaths and four serious injuries. The FDA believes electrostatic discharge can result in the external controller losing power.
In addition to problems surrounding the device's external controller, the FDA also noted 238 complaints related to battery failure.
In total, the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA has received more than 500 adverse event reports concerning the Heartware VAD with at least 76 of the reported events resulting in death.
Problems Cited by FDA in HeartWare Warning Letter
In their warning letter, the FDA notes that HeartWare:
- Failed to properly address issues related to electrostatic discharge.
- Failed to take effective actions related to loose driveline connectors.
- Failed to adequately implement procedures for corrective and preventive action related to battery failure.
- Failed to properly maintain measures to validate device design.
- Failed to validate computer software used with the device.