J&J’s Abiomed Issues Device Correction for Impella Heart Pump Over TAVR Complications

Johnson & Johnson’s Abiomed division is again the subject of a Class I recall for its Impella heart pumps, this time regarding patients with a transcatheter aortic valve replacement (TAVR).
 
According to the company’s device correction, there’s potential risk of unintentional interaction of the Impella motor housing with the distal stent of a TAVR, resulting in destruction of the impeller blades. This results in low flow from the damaged Impella system.
 
Abiomed said the TAVR’s outflow struts can enter Impella’s outflow opening and damage the impeller during Impella repositioning while the impeller is spinning. The interaction can cause fracture of the impeller material.
 
No events have yet been identified, though the company said systemic embolization of the fractured impeller material can occur.
 
“This complication has been observed in 0.7% of patients (27 complaints) with TAVR who were supported by the Impella system from 2016 to present,” the device correction states. “25 out of 27 complaints involved the Impella CP. For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.”
 
Risk of interaction increases for oversized or under-expanded frames with distal ends that aren’t flush with the aortic wall, causing the distal stent structures to be oriented in a way to potentially enter the outflow window. This could allow contact of the stent’s end with the spinning impeller.
 
Abiomed said it’s revising the IFUs for the pumps subject to recall. The company cautioned clinicians to position Impella carefully in TAVR patients and avoid repositioning while the device is spinning. The device should be turned to P0 during repositioning or any movement that might bring the outlet windows near the valve stent structures.

In an emailed statement to MPO, Abiomed stated, “At Abiomed, our first priority is our patients, including the safe and effective use of our products. On June 14, we issued a notification to customers regarding the safe use of left sided Impella heart pumps in patients with a transcatheter aortic valve replacement (TAVR) valve. The notification addresses the potential risk for unintentional interaction of the Impella motor housing with the distal stent of a previously implanted TAVR valve and provides further recommendations on how to position Impella in these patients. This notification was not a device removal. These devices remain available, and Impella technology can continue to be used safely in patients with a previously implanted TAVR valve.”