Thoratec Recalls Heart Pumps After DeathsOct 27, 2008 | Parker Waichman LLP
Five deaths have prompted the Thoratec Company to recall its HeartMate II implantable heart pumps. According to the Food & Drug Administration (FDA), wear and tear of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (LVAS) blood pump with the System Controller may result in damage that could interrupt pump function. Thoratec has urged patients with the implantable heart pump to contact their doctors in order to have their device checked.
HeartMate II LVAS received FDA approval in April 2008 as a bridge-to-transplant (BTT) treatment option for patients suffering from advanced-stage heart failure. The device was the first continuous flow chronic LVAS to receive FDA approval for BTT in the US.
Thoratec said it has confirmed 27 reports where wear and tear to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. However, in five cases, pump replacement was not feasible and the patients died The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.
The affected HeartMate II LVAS can be identified by the catalogue number located on the label of the package. Those subject to this action have Catalogue No. 1355 or 102139, and were distributed since the beginning of clinical studies in November 2003. The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries.
Thoratec is sending an Urgent Medical Device Correction letter to hospitals identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter.