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Thoratec HeartMate II LVAS Recall Deemed Class I | 24-7-news.com cialis online

Thoratec HeartMate II LVAS Recall Deemed Class I

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The Thoratec HeartMate II Left Ventrical Assist System (LVAS) recall has been deemed a Class I by the U.S. Food & Drug Administration (FDA). A Class I recall is the agency’s most serious and involves a situation in which there is a reasonable probability that the use of or exposure to a violative product—in this case, the Thoratec HeartMate II LVAS, a heart pump device—will cause serious adverse health consequences or death.

The recall has been implemented over a blood flow problem, said The Wall Street Journal. The defect involves a detachment of the device’s bend relief from its intended position around the proximal outflow graft. This defect may allow the graft to kink or deform, which can cause a reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft. The metal end of the bend relief may also be sharp and may cause erosion and cutting of the outflow graft. Thoratec HeartMate II LVAS model numbers 103393, 103695, 104692, 104911, 104912 are involved.

The Thoratec HeartMate II LVAS is used as a bridge to transplantation in heart transplant candidates at risk of imminent death from nonreversible left ventricular failure. The device is also indicated for use in patients with New York Heart Association (NYHA) Class IIB of IV end-stage left-ventricular failure who have received optimal medical therapy for at least 45 of the prior 60 days and who are not heart transplant candidates.

The Thoratec HeartMate II delivers blood from the dysfunctional left ventricle of the patient’s heart to the body and is an axial-flow, rotary ventricular assist system that can generate blood flows up to 10 liters per minute (one beat per minute). The recalled device is meant for both home and hospital use and use during transportation of ventricular assist device patients by ground ambulance, airplane, or helicopter.

The labeling on the Thoratec HeartMate II LVAS has been revised to provide instructions on how to verify if the bend relief is fully engaged with the sealed outflow graft at the time of implant, and has also been revised to include a new caution statement regarding the bend relief connection. Clinicians have been instructed to follow the revised instructions that clarify the recommended procedure for securing the bend relief to the outflow graft.

Meanwhile, The Journal noted that the recent FDA announcement is actually a repost of a prior FDA decision to assign its most serious recall classification to the Thoratec HeartMate II. The decision was initially placed in the FDA web site on March 23. A month prior, on February 23, Thoratec first advised physicians of the problem and the labeling revisions—caution statement and implant instructions. The notification noted that, should the pump not be properly connected, low pump flow or worsening heart failure symptoms could occur, said The Journal.

Of note, said The Journal, a product recall has actually not been instituted and patients with the HeartMate II device may continue to use it; however, future implantations should follow the revised instructions and warnings. The FDA explained to The Journal that the term “recall” is used “when a medical device is defective, when it could be a risk to health, or when it is defective” and also a health risk. The term does not always mean that patients must cease using the device.

Prior to physician notification, Thoratec received 29 reports of the heart pump not being properly connected; five cases needed surgery and, in one case, a patient died, although the cause was unclear, according to Thoratec, said The Journal.

The system, which costs more than $100,000, includes an implanted pump connected by a cable to an external controller and batteries, said The Journal. There is no alternate therapy to HeartMate for the heart-failure patient population. At year-end 2011, over 4,000 HeartMate II patients were receiving ongoing life-restoring support, said Thoratec, which noted that former Vice President Dick Cheney utilized a HeartMate device until his recent heart transplant, said The Journal.

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