FDA Cites HeartWare, After Reports of 2 Deaths and 4 Serious Patient Injuries

Heartware's Ventricular Assist Device system may have caused the death of two individuals and injured four other patients seriously, according to a violation letter sent to the company by the U.S. government.

In a letter to HeartWare CEO Doug Godshall from the U.S. Food & Drug Administration, the FDA said it received 27 complaints about failure for its ventricular assist device, of which electrostatic discharge was determined to be the most likely root cause. 

"Your firm initiated corrective actions including labeling changes to the Patient Manual released to new patients in July 2013 and a Safety Alert Letter to doctors in May 2013. However, your firm failed to verify or validate the effectiveness of these corrective actions," said the FDA letter to Heartware.

The complaints include reports of two deaths and four serious injuries between Feb. 2010 and Nov. 2013.

Heartware develops and manufactures miniaturized implantable heart pumps in patients suffering from advanced heart failure. The devices have treated more than 5,000 patients in more than 35 countries. The system was approved in Europe and Australia in 2009.

Heartware's Ventricular Assist System received FDA approval in Nov. 2012, as a bridge to transplant therapy for patients with advanced heart failure. 

In the U.S. a device is implanted in a patient and it operates via a battery pack attached to the patient, until a transplant is available.

"Your firm initiated field actions in response to complaints regarding loose driveline connectors. However, corrective actions were not effective in that driveline connectors again came loose," stated the FDA violations letter. 

"Your firm’s responses are not adequate," wrote the FDA. "Your firm initiated changes to procedures and training of personnel. However, 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."

The FDA also received 238 complaints of premature battery failure and 119 MDR events. 

The FDA inspected the company's production facility in Miami Lakes, Florida in January. Heartware's corporate HQ is in Framingham.

"HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our device, and we are dedicated the resources necessary to address the items discussed in the letter," Godshall, company president and CEO, said in a statement.

The FDA gave Heartware 15 business days to provide "specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken."

In spring 2014, Heartware located its corporate offices to 500 Old Connecticut Path in Framingham.  In 2013, Heartware's revenue was more than $200 million.