Thoratec Issues Safety Advisory for HeartMate II following Patient Deaths
Medscape reports that Thoratec is pushing for a label change and is suggesting that patients retrain with the HeartMate II Pocket System Controller following four patient deaths and several other reported complications.
About the HearMate II Safety Advisory
The Heartmate II Pocket System Controller is a discrete device that sounds alarms, provides diagnostic information and controls how a patient’s left ventricular assist device (LVAD) operates.
According to Thoratec, multiple complications occurred when patients trained on the older EPC System Controller experienced difficulties switching from their device’s primary controller to a back up controller upon receiving the HeartMate II Pocket System Controller.
Two of the reported deaths occurred after patients attempted to exchange the system controllers while alone. The company did not comment on the other two deaths beyond stating that they were not caused by device malfunction.
Devices Affected by the Safety Advisory
According to Thoratec, the advisory covers the following products:
- HeartMate II Impant Kits with Pocket Controllers with catalog numbers 106015 and 160016.
- Pocket Controlers with catalog numbers 106762 and 106017
- HeartMate II LVAD Pump and Pocket Controller Kits with the catalog number 107801
- Any Pocket Controllers that have been removed from their packaging with the model number 105109.