Food and Drug Administration Malfunction Recalls of Left Ventricular Assist Devices

Abstract

Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term.

Mechanical Device Malfunction of the HeartMate II Versus the HeartMate 3 Left Ventricular Assist Device: The Rotterdam Experience

“…18 Corrective measures from Abbott contain a locking clip and later a redesign of the bend relief tube connection to the pump. 16 Last, a compressed outflow graft caused low flow problems in one of our patients when a blood clot wedged itself between the bend relief tube and the outflow graft. A recent study suggested resolving this stenosis with a stent.…”

“…Recalls from Abbott in 2014 and 2017 reported four and 26 deaths, respectively, and addressed this remaining matter of concern. 16 This is an example of a potential major malfunction because there is a pump stop of transient nature when the controller is replaced. During the years, we changed our LVAD management program to optimize patient care including; dedicated mechanical circulatory support coordinators, yearly training for our patients (with special focus on changing the controller), and stringent echocardiographic follow-up instead of only focusing at the LVAD parameters.…”

“…The patients had three different malfunction mechanisms, including kinked grafts, a twisted graft and a compressed graft due to blood clots in between the bend relief tube and the graft. [15][16][17] Kinks in the outflow graft occur between the end of the bend relief tube and the aortic anastomosis, when the outflow graft is too long, either because of surgical errors or the heart tends to shrink over time when supported with an LVAD. A twisted outflow graft is caused by the bend relief tube which could e84 rotate freely in the original design.…”