March 5, 2014 — Following reports of four deaths and five injuries linked to the HeartMate II LVAS Pocket System Controller, Thoratec Corporation has published a Safety Advisory recommending that patients contact their doctor and review updated labeling and training materials.
The HeartMate II is a Left Ventricular Assist System (LVAS), which is a mechanical pump that continually circulates blood through the heart. It is also known as a “bridge to transplant,” because it is used in patients with advanced heart failure who are awaiting a transplant or surgery.
The advisory is being issued because some patients and caregivers have had problems changing from a primary system controller to a backup system controller. These difficulties have resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion (decreased blood-flow through the heart), causing low oxygen in the bloodstream.
Of the nine incidents, eight occurred in patients who were originally trained on an older model (EP System Controller) and switched to the Pocket Controller. Two deaths occurred in patients who switched controllers alone instead of in a hospital, contrary to labeling.
Patients who were receiving the Pocket Controller as a replacement for an older model are at a higher risk of experiencing problems with the controller exchange process.
HeartMate II Pocket System Controller can be identified by catalog numbers:
- HeartMate II Implant Kit with Pocket Controller: Catalog Number 106015 and 106016
- Pocket Controller: Catalog Numbers 106762 and 106017
- HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
- Pocket Controllers that have been removed from packaging: Model Number 105109 (found on side of each unit)