Devices

FDA Early Alert on Watchman Devices

FDA has issued an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to prevent air embolism events. The devices are intended to provide vascular and transseptal access for the family of Watchman FLX Left Atrial Appendage Closure Devices with Delivery Systems.

The alert says that the company has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. “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,” the alert says. “This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.”

The company says that during procedures performed without positive pressure ventilation, there is a known risk of air embolism leading to severe outcomes, including life-threatening or fatal consequences. “These outcomes have been observed in this investigation and include arrhythmia, hemodynamic collapse, stroke (CVA), or other end-organ failure caused by ischemia,” the agency says.

The alert says that the risk of air embolism is acute in nature and limited to the duration of the implant procedure. “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,” it adds. To date, the company says it has reported 120 serious injuries and 17 deaths associated with the issue.

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