The FDA is reviewing the firm s Corrective Action Plan that addresses these problems. Once we receive evidence that the firm has appropriately changed their systems and procedures, and the FDA has reviewed their regulatory submissions, we will assess whether the product can be returned to the market. This device has a fabric graft supported along its entire length by a series of metal rings sutured to the graft. The endograft is held in place by the radial force applied by the rings to the patient s aorta. FDA is concerned about reports of approximately 25 aneurysm ruptures, as well as other serious adverse events, in patients who have received AneuRx .
Recommendations Stay Informed .
Endovascular repair of AAA is a new and evolving technology, and both Ancure and AneuRx have undergone changes in design and labeling during the premarket and postmarket phases. Anticipate that there will be changes and improvements as more clinical experience accumulates with this class of devices. We recommend that you carefully follow the device manufacturer s most recent warnings, precautions, and instructions regarding patient selection and device use. Make sure that all implanted patients are carefully followed, and undergo periodic follow-up imaging. Patients who are unlikely to adhere to the manufacturer s graft follow-up recommendations may be poor candidates for endovascular repair, even if they are otherwise suitable.