THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Description of Event or Problem

It was reported that the patient had known Driveline Faults and the patient had no symptoms. Log Files were sent for review. The Log Files captured constant Driveline Fault Events throughout. There were no changes from the last Log File review back in March 2026. Log Files still showed the green wire was likely broken and the other 5 wires functioned as intended. No other unusual events were seen in the Log Files. The patient's Driveline status was monitored with intermittent Log Files to make sure other wires are intact.

Additional Manufacturer Narrative

Manufacturer's Investigation Conclusion:Review of the submitted Log File confirmed the reported Driveline Fault alarms. Based on previous complaint history and similarly reported events, the Driveline Faults observed in the submitted Log File appeared to be consistent with potential Driveline wire compromise; however, a specific cause for the alarms could not be conclusively determined through this evaluation. The submitted Log File contained data from 21Jun2026 through 08Jul2026. Persistent Driveline Fault alarms were captured throughout the Log File. No other notable events or alarms were captured, and the Pump appeared to have been operating as intended above the Low Speed Limit for the duration of the File. The patient remains ongoing on HeartMate II Left Ventricular Assist System, serial number (b)(6), with no further issues reported at this time.The relevant sections of the Device History Records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The HeartMate II Left Ventricular Assist System (LVAS) Instructions for Use (IFU) and the HeartMate II LVAS Patient Handbook are currently available. The current revisions of the IFU and Patient Handbook can be found on the eIFU page of the Abbott website. Sections 6 and 8 of the HMII IFU, as well as Sections 4 and 6 of the HMII Patient Handbook, provide information regarding how to care for the Driveline; however, all HeartMate II Drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time. These documents address damage due to wear and fatigue of the Driveline and outline indications of Driveline damage, as well as the how to respond to such events. These documents instruct the user to check their Driveline daily for signs of damage, such as cuts, holes, or tears. The Patient Handbook also instructs the user to call their hospital contact right away if the Driveline is damaged (or might be damaged). Section 7 of the IFU, ¿Alarms and Troubleshooting¿, and Section 5 of the Patient Handbook, ¿Alarms and Troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition. The Patient Handbook also contains a section on Handling Emergencies and further instructs the user to call their hospital contact if the patient thinks that, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided. The manufacturer is closing the file on this event.