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Deaths Prompt Thoratec Heart Pump Recall

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The Thoratec Company is urging patients with its HeartMate II Left Ventricular Assist System (LVAS) blood pump to have their doctors check the device, after they were linked to the deaths of five patients. 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.

HeartMate II LVAS  received Food & Drug Administration (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.

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