Thoratec—Model 105109 HeartMate II System Pocket Controllers: Users May Experience Difficulty Exchanging System Controllers

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In a March 4, 2014, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Thoratec states that it has received 4 reports (0.2% of the patient population) of patient deaths occurring during attempts to exchange one pocket system controller for another. Two of the deaths occurred when patients attempted to exchange controllers while alone and, contrary to the labeling, without contacting the hospital first. Another 5 patients (0.2% of the patient population) experienced temporary loss of consciousness or other symptoms of hypoperfusion while exchanging pocket system controllers. The system controller is the external unit that controls the function of the implanted HeartMate II left ventricular assist device (LVAD, see Figure 1 in the Urgent Medical Device Correction letter). Thoratec states that its investigations have not revealed any deficiencies in quality control procedures or failure of the devices to meet specifications. Thoratec states that 8 out of 9 events occurred with patients who were converted to the pocket system controller after being originally trained on the EPC system controller at the time of their HeartMate II LVAS implantation. The increased risk of serious injury or death when pocket system controllers are exchanged may be associated with the inability of the patient and/or caregiver to make a complete connection between the driveline and the pocket controller in a timely manner. These patients may not have received adequate training regarding the differences between the two controllers, especially the differences related to connection of the driveline. FDA states that the manufacturer notified its customers in an Urgent Medical Device Correction letter on March 4, 2014. The manufacturer has not confirmed the information provided in the source material.

Action Needed: Identify any affected product in your inventory. If you have any affected product, verify that you have received the March 4, 2014, Urgent Medical Device Correction letter, Addendum to Instructions for Use and Addendum to Patient Handbook, acknowledgment form, and training confirmation form from Thoratec. Review the addendum with all relevant personnel. Complete the acknowledgment form, and return it to Thoratec using the instructions on the form. Retrain and reassess all ongoing patients and caregivers on exchanging pocket system controllers using the revised labeling, prioritizing the retraining of patients that were converted to the pocket controller from a previous model of system controller. After training, sign the training confirmation form and return it to Thoratec using the instructions on the form. U.S. customers should report serious adverse events or product quality problems relating to the use of affected product to FDA's MedWatch Adverse Event Reporting program...