The US Food and Drug Administration (FDA) has issued a Class I Recall of Abbott’s HeartMate 3 Left Ventricular Assist System, because of potential malfunction that may lead to graft occlusion.
The recall has been made because of a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time.
Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. Reduction in pump could lead to serious adverse effects including blood clots and death.
The recalled HeartMate 3 Left Ventricular Assist System with Model/Item Numbers include Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international), with all the Lot Numbers and with all the manufacturing dates.
Distribution dates range from 2 September 2014 to the present date. 4878 devices in the US have been recalled so far.
The HeartMate 3 Left Ventricular Assist System helps in delivering blood from the heart to the rest of the body. It is used for short-term support for patients who are at the risk of death from end-stage left ventricular heart failure, such as patients awaiting heart transplant.
The system includes a blood pump that works in the space around the heart (pericardium) along with an outflow graft that connects the pump to the aorta.
FDA has recommended that those patients who experience a persistent low flow alarm should contact the physician managing their HeartMate 3 Left Ventricular Assist System immediately. The company has also stated not to remove the device because of this issue.
On 21 May, Abbott has sent an Urgent Medical Device Recall notification to physicians, alerting them again to the device malfunction and to provide them with the instructions to manage patients getting the device or patients who already have the device implanted.
Physicians have been advised to lead their patients as per the recommendations from the American Society of Echocardiography (J Am Soc Echocardiogr 2015;28:853-909), as per which, “an LVAD surveillance echo exam should be considered at approximately 2 weeks after device implantation or before index hospitalization discharge (whichever occurs first), followed by consideration of surveillance transthoracic echo (TTE) at 1, 3, 6, and 12 months post implantation and every 6 to 12 months thereafter.”
TTE imaging is not a definitive tool to identify an outflow graft twist obstruction. But, it can be used as an indirect assessment of obstruction by imaging the size of the left ventricle, the mitral valve and aortic valve opening and diastolic velocity (inflow or outflow).
If the low flow alarm is persistently going off, even if the issue has been resolved after all the relevant patient medical conditions have been ruled out as the cause, a Computed Tomography (CT) angiogram should be urgently obtained, if there are no contraindications, to identify a possible outflow graft twist occlusion.
If a 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 bending, abrasion or occlusion of the outflow graft at the graft’s attachment point to the pump.