· FDA Recall. Impella LV preforation risk.
February 2024.
Impella Left Sided Blood Pumps are used for short term support of the left ventricle during high risk pci or cardiogenic shock. At present, the Impella CP and the Impella 5.5 models are the devices available for use. Abiomed recalls the IFU due to perforation risks.
This event may cause serious adverse health consequences, including:
· Left ventricle perforation
· Free wall rupture
· Hypotension
· Tamponade
· Death
The company's recommendations are:
A. For Impella CP
1. Inlet position should be 3.5cm below aortic plane
2. During PCI be aware if the pump shifts deeper
3. Fix the catheter using Tuohy-Borst valve...
4. If a deeper position is noted, PCI should be paused and Impella pulled back.
5. Prior to leaving the cath-lab position should be confirmed with echo...
B. For Impella 5.5
1. Inlet position 5cm below aortic plane...
2. Consider reposition to a temporary shallower position (3.5cm) during surgery.
3. Especial caution during heart manipulation during surgery.
C. For both Impella CP and Impella 5.5
1. Use imaging when advancing or torquing the pump catheter...
2. Special care when high risk conditions:
· Reduced LV cavity.
· LV Aneurism.
3. Special care during and after CPR.
Source:
