March 5, 2014 — Thoratec Corporation has issued a Safety Advisory after receiving reports of four deaths and five injuries associated with the HeartMate II LVAS Pocket System Controller. Patients are at risk of problems when exchanging an older controller for the Pocket Controller.
The Pocket Controller is used with the HeartMate II Left Ventricular Assist System (LVAS), which is a “heart pump” that continually pushes blood through the heart. It is used in patients with end-stage heart failure who are too weak to undergo surgery and/or are awaiting a heart transplant.
Thoratec recommends that patients talk to their doctor and review updated labeling and training materials. Out of nine incident reports, eight involved patients who switched to the Pocket Controller after using an older model, the EP System Controller. The deaths and injuries occurred due to hypoperfusion (loss of blood-flow through the heart), which can cause loss of consciousness and low oxygen in the bloodstream.
Catalog numbers of affected HeartMate II Pocket System Controllers:
- 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)