After four patient deaths, Abiomed clarified to customers of its Impella Left Sided Blood Pumps that the device could break a distal stent's blade in transcatheter aortic valve replacement patients.
The pumps' original instructions "do not adequately address precautions" clinicians should bear in mind when using the device in patients who have had TAVRs, the FDA said. If the distal stent's motor impeller blades are damaged, broken blades can enter a patient's bloodstream, or the pump can stop or delay.
As of July 27, 30 complaints and 26 injuries have been reported. The correction is labeled as a Class I event.
Abiomed is not recalling the product; additional instructions were sent to customers and the device can be used.