FDA says Watchman access systems may increase risk of air embolism—17 deaths reported
Boston Scientific’s Watchman device is associated with a heightened risk of air embolism events if the implant procedure is performed without positive pressure-controlled ventilation, according to the U.S. Food and Drug Administration (FDA). Air embolism is a rare, but potentially fatal complication that occurs when air enters the bloodstream and creates a blockage in a patient’s blood vessel.
“According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress,” according to a new FDA advisory. “This risk is especially prevalent in patients with preexisting low left atrial pressure, hypovolemia and partial upper airway collapse.”
The FDA emphasized that air embolism can lead to “severe outcomes, including life-threatening or fatal consequences.”
The Watchman TruSteer Access System. Image courtesy of Boston Scientific.
Because of this risk, which has been associated with 120 serious injuries and 17 deaths as of July 30, Boston Scientific is updating the instructions for use of several access systems used to implant the Watchman device in patients with nonvalvular atrial fibrillation. Physician training is also being updated to highlight this issue.
This alert covers all lots of the following Boston Scientific access systems:
- Watchman TruSeal Access System SGL, OUS
- Watchman TruSeal Access System DBL, OUS
- Watchman TruSeal Access System ANT, OUS
- Watchman FXD Curve Access Sys Dbl, OUS
- Watchman FXD Curve Access Sys Dbl, US
- Watchman TruSeal Access System SGL, US
- Watchman TruSeal Access System DBL, US
- Watchman TruSeal Access System ANT, US
- Watchman FXD Curve Access Sys Sgl, US
- Watchman FXD Curve Access Sys Dbl, US
- Watchman TruSteer Access System, US
This is not a device removal. However, clinicians using these devices should ensure they use the updated instructions from Boston Scientific, which now include additional warnings that outline this air embolism risk.
“The risk of air embolism is acute in nature and limited to the duration of the implant procedure,” according to the FDA. “Patients who have a previously implanted Watchman device do not require additional patient management and should continue to follow standard patient care at the discretion of their physician.”
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.