The agency cited violations in design and software validation as well as complaint management and documentation, according to the FDA notice. The warning cites in particular the potential mismanagement of at least 27 complaints about HeartWare’s products, including 2 reported deaths and 4 serious injuries.
"Your firm initiated field actions in response to complaints regarding loose driveline connectors,"the FDA wrote. "However, corrective actions were not effective in that driveline connectors again came loose."
In April HeartWare reiterated a warning about failed locking mechanisms in the patient driveline connectors on its left ventricular assist device, an implantable heart pump. The company has already received multiple complaints of failed locking mechanisms in the patient driveline connectors, which connect the implanted circulatory assist device to an external controller that powers and monitors the device. In half of those cases, the disconnected driveline connector resulted in a temporary stop in pumping therapy, which HeartWare said "could cause serious injury or death, depending on the function of a patient’s native heart."
None of the patients associated with the initial complaints were injured, HeartWare said at the time.
HeartWare’s response to the problem was deemed "inadequate" by the FDA’s inspectors, who said that changes in procedure and re-training of personnel weren’t enough.
"Your firm did not indicate what actions will be taken to assess the effectiveness of the corrections and whether retrospective assessments will be performed to determine if the root causes were adequately addressed by the corrections," inspectors wrote.
Other citations included insufficient validation of computer software, failure to maintain proper records of investigations and inadequate procedures for validating device design.
HeartWare had advised last month that such the formal warning was on the way.
"The company expects to implement new and enhanced systems and procedures, and will perform additional actions as may be required to resolve the issues raised in the FDA communication," the company said at the time. "The letter issued by FDA does not require any action by physicians or patients and does not restrict use of HeartWare’s devices."
The FDA warning, dated June 2, 2014, was published online on June 26, according to the website.
HTWR shares were down 2.8% today, trading at $87 as of about 1:30 p.m. EST.