Important Safety Alerts

Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its HeartMate 3 (HM3) Left Ventricular Assist System [Catalog Number: 106524INT – HM3 LVAS KIT].

The manufacturer has received reports of outflow graft twist occlusions in the HeartMate 3 Left Ventricular Assist System. As a result, patients whose devices experience these outflow graft occlusions will experience a persistent low flow alarm.

According to the manufacturer, there are 32 total reports associated with outflow graft twisting in the HM3 device, an occurrence of 0.72 percent based on 4,467 implants worldwide Outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death. Postoperative twisting and occlusion of the HM3 outflow graft may result in the need for surgical intervention following the original implant procedure.

The affected users are advised to take the following actions:

• During implant, when attaching the Outflow Graft to the Pump Cover, a clicking sound will be heard as the Screw Ring is tightened. Continue turning the Screw Ring clockwise until it comes to a complete stop and stops clicking for a firm hand tightened connection.
• If a low flow alarm persists at any time following implant, and other potential causes such as hypertension, low preload, right-heart failure and inflow occlusion have been considered for cause, a Computed Tomography angiography should be taken to identify the possibility of an outflow graft twist occlusion.
• In the event surgical repair of the outflow graft is needed due to a twist occlusion, the Outflow Graft Bend Relief should be reattached in its original state or repaired to prevent further kinking or occlusion of the graft.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 12 April 2018