Thoratec LVAS Heart Pump Recall
Thoratec LVAS Heart Pump Recall Side Effects May Result In False Claim Lawsuits
Thoratec LVAS Heart Pump Recall | Lawsuits, Lawyers | Side Effects: Injury, Death | Percutaneous Lead Damage, Defective Device
The lawyers and attorneys at our firm are offering free case evaluations to people injured by the Thoratec HeartMate II Left Ventricular Assist System (LVAS). In October 2008, the Thoratec Company recalled the implantable heart pumps after a defective lead was implicated in five patient deaths. If you or someone you love was injured by this defective device, we urge you to contact one of our Thoratec HeartMate II LVAS heart pump recall lawyers as soon as possible to protect your legal rights.
Thoratec said in its HeartMate II LVAS recall notice that it has confirmed 27 reports where wear and tear to the device's percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants.
Thoratec HeartMate II LVAS Deaths
According to Thoratec, 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. However, our Thoratec HeartMate II LVAS heart pump recall lawyers believe this rate could be much higher, as not all adverse events caused by a device are reported to manufacturers.
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 Thoratec HeartMate II LVAS heart pump recall lawyers have determined that this device was not subject to adequate testing. Had it been, Thoratec would have discovered the problems with the percutaneous lead earlier, and these injuries and deaths may have been prevented.
Thoratec HeartMate LVAS Recall
The affected HeartMate II LVAS can be identified by the catalog number located on the label of the package. Those subject to this recall have Catalog 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.
At the time of the recall, Thoratec urged patients with the implantable heart pump to contact their doctors in order to have their device checked. Thoratec also said it was 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 were also asked to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients were advised to contact Thoratec for further instructions if they had not receive the Medical Device Correction letter.
Thoratec said the labeling for the HeartMate II LVAS would be revised with the updated risk information related to percutaneous lead damage. The failure to include this information on the label at the time this device was first marketed has been deemed an act of negligence by our Thoratec HeartMate II LVAS recall lawyers.
Thoratec HeartMate II LVAS Background
The 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 U.S.
The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, the HeartMate II can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle
FDA approval of the HeartMate II for BTT, followed a national clinical trial involving 46 centers in the U.S. and Canada and approximately 450 BTT patients, including those enrolled under Continued Access Protocols and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.
The approval was based on data from just the first 194 patients enrolled in the trial. The Thoratec HeartMate II LVAS heart pump recall lawyers at our firm have determined that this testing was nowhere near adequate, as evidenced by the failures of the percutaneous lead that prompted the recall just months after the device's approval.
Thoratec claims the device is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The company also claims that the device has a much longer functional life than the previous generation of devices. Unfortunately, because of the problems with the percutaneous lead, that claim has proven false.
Legal Help for Victims of Defective Thoratec HeartMate II LVAS Heart Pumps
If you or someone you love were injured as a result of the defective Thoratec HeartMate II LVAS implantable heart pump, you have valuable legal rights. Please fill out our online form, or call 1-800 YOURLAWYER (1-800-968-7529), to speak with an experienced Thoratec HeartMate II LVAS heart pump recall lawyer about your case.