Abbott updates heart device instructions to highlight safety risk
Abbott is recalling its Amplatzer Amulet Left Atrial Appendage Occluder due to an update to its instructions for use (IFU). The goal is to keep clinicians from implanting the device too close to the patient’s pulmonary artery.
Unlike many recalls, no devices need to be returned to the manufacturer. Instead, clinicians have been instructed to reference these new IFU before performing any Amulet procedures going forward.
Update points to potential risk of pulmonary artery injury
The old IFU warned clinicians not to place the self-expanding device where it may “interfere with any intracardiac or intravascular structures.” The warnings have now been updated to say that implanting the device too close to the patient’s pulmonary artery is associated with an increased risk of perforation.
Amplatzer Amulet Left Atrial Appendage Occluder images courtesy of Abbott.
According to Abbott, perforating the pulmonary artery would be a “serious adverse event” resulting in “pericardial effusion, cardiac tamponade and potentially death.” To avoid that risk, the company urged users to pay close attention to the closest distance between the Amulet device and the patient’s pulmonary artery once the landing zone has been identified.
Any distance ≤ 1.5 mm is associated with a “significant risk,” any distance from 1.5 to 3 mm is associated with a “theoretical risk” and any distance > 3 mm is associated with “a lower risk.”
In certain cases, clinicians may find that a different landing zone or device orientation can help reduce the risk of injury. If the risk of injury is high and cannot be minimized, Abbott noted, it may be necessary to cancel the procedure altogether.
Update ruled a Class II recall by FDA
While no devices need to be returned to the manufacturer, the U.S. Food and Drug Administration (FDA) did categorize this action as a Class II recall.
The recall covers all lots of the following model numbers:
- 9-ACP2-007-016
- 9-ACP2-007-018
- 9-ACP2-007-020
- 9-ACP2-007-022
- 9-ACP2-010-025
- 9-ACP2-010-028
- 9-ACP2-010-031
- 9-ACP2-010-034
Additional details from the FDA are available here.
Amulet procedures are an established treatment for minimizing stroke risk
The Amulet device, which first secured FDA approval in 2021, is used to minimize the risk of stroke in certain high-risk patients with nonvalvular atrial fibrillation. A recent study linked treatment with the device to long-term safety and effectiveness.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.