Medical Device Daily

Thoratec (Pleasanton, California) reported a double dose of bad news just days after presentation of positive news for its HeartMate II at this week’s scientific sessions of the American Heart Association (Dallas) in Orlando: specifically, the implantation and efficacy of the HeartMate II ventricular assist device (VAD) in a larger number of women than usually represented in a clinical trial, and also that the device has been scheduled for an FDA panel assessment later this month (Medical Device Daily, Nov. 6, 7, 2007).

But yesterday the company said that on Oct. 19 it initiated a worldwide recall of all of its implantable ventricular assist devices (IVAD), with Catalogue No. 10012-2555-001, serial numbers 488 or higher and manufactured and distributed since October 2004.

The company also said it may recall about 5,800 ProTime System anticoagulation monitoring devices made by its subsidiary, International Technidyne (ITC; Edison, New Jersey), which received an FDA warning letter stating concerns about its quality systems. The ProTime System is used to monitor clotting activity in blood in patients on anticoagulant therapy.

Regarding the IVAD recall, Thoratec said these devices may be implanted in the pre-peritoneal (internal) position or placed in the paracorporeal (external) position. It said that in the paracorporeal position “the pneumatic driveline is entirely external to the patient and may be damaged if the driveline is bent at a sharp angle relative to its junction with the pump housing which could cause a reduction or interruption of circulatory support, potentially resulting in serious injury or death.”

So far, the company said that five injuries and one death had been reported due to this problem. In the incident that resulted in a death, a damaged driveline severed at its connection to the pump.

The company said it received seven reports of damaged drivelines in paracorporeal IVADs, These seven reports, it said come from about 45 IVADs placed in the paracorporeal position.

The affected IVADs were distributed to 87 hospitals throughout the U.S. and other countries, Thoratec said. They can be identified by the serial number located both on the label of the sterile package and on the connector at the end of the IVAD driveline.

Thoratec said that “until further notice,” it is advising that the device not be placed in the external position. It stressed that the action does not affect its implanted IVADs.

The company said the FDA ProTime warning letter relates to manufacturing and quality control issues involving a part from an outside supplier that could cause specific lots of the system to deliver error messages on the display, instead of test results, and/or the remote possibility of incorrect readings of patient blood clotting levels.

Thoratec said that ITC is scheduled to meet with FDA to discuss the warning letter and the company’s responses, and believes it will have to voluntarily recall about 5,800 of the ProTime systems.

The company said it is not aware of any patient-related issues related to this matter, that it believes the issue “has been addressed” and shouldn’t affect future ProTime System shipments.

The company estimated the recall will cost $500,000 to $1 million, and therefore won’t affect FY07 financial guidance.

Bear Stearns med-tech analyst Rick Wise wrote in a research note that that while Thoratec’s shares will likely come under some pressure due to uncertainty surrounding the warning letter and its potential financial impact, the long-term driver of its stock performance will be HeartMate II, its second-generation left VAD. He said he expects that the FDA advisory panel will recommend approval of the HeartMate II.

He said that with a projected 1Q08 approval and launch, commercial uptake of the HeartMate II “will help drive 59% 2009 EPS growth” for Thoratec.