Question of the Month with Comment
MedSun: Newsletter #3, April 2006
We are going to be implanting, for the first time, a pressure monitoring device during an endovascular repair of an abdominal aortic aneurysm. The device is implanted between the stent and the wall of the aneurysm to monitor the pressure in the aneurysm sac post stent implantation. This device is new to the market. Is this considered a “trackable” device?
From FDA: FDA has not required this device to be tracked. FDA requires certain (relatively few) devices, such as automatic implantable cardioverter/defibrillators, to be tracked from their manufacture through the distribution chain. The purpose of device tracking is to ensure that manufacturers will be able to promptly locate the devices in commercial distribution. Tracking information is typically used to facilitate notifications and recalls ordered by FDA when the devices present serious risks to public health.