Medical device adverse event reports and the Food and Drug Administration

Abstract

You are asked to assist a surgeon who has inserted a coated woven aortic vascular graft and who now wishes to add a bypass to the hypogastric artery. He indicates a preference for using the thermal cautery to make the orifice for the graft because it is woven, but when the cautery is applied, the graft ignites. The fire is controlled, but the aortic graft requires replacement. The patient has suffered no immediate consequences, but anesthesia and operating room (OR) times have been prolonged. You are asked for advice on how to report this event. The first concern is obviously for the potential risk to other patients, so product information is reviewed and you learn that some coated woven grafts should be soaked in saline if thermal cautery is used to make an orifice. The Risk Manager should be notified by the OR supervisor of the event, and you confirm that this was done. Once all patient care documentation has been completed, this could be a Sentinel Event under the Joint Commission for Accreditation of Healthcare Organizations Guidelines, which requires formal reporting within 45 days, but the fact that the patient suffered no direct disability removes it from that category. However, the hospital has a legal obligation to report the event to the manufacturer within 10 working days. There may also be a requirement for reporting to the state health department under an individual state health code. The manufacturer also has a legal obligation to make a report to the Food and Drug Administration (FDA) within 30 days when there is a death or serious injury in which a device may have caused or contributed to the adverse event. But how can other surgeons learn about this potentially dangerous situation? It is unfortunate that so few physicians are aware of the importance of reporting their own experience with adverse