Characterization of Adverse Event Reports for Neurovascular Coil Embolization Devices
Abstract – Brain aneurysms result from focal weakening of blood vessel walls within the cerebral vasculature; risk factors include hypertension, smoking, and family history. Neurovascular embolization coils are commonly used to halt growth and prevent rupture of brain aneurysms. These metallic coils are inserted via catheter into the center of the aneurysm, and function by inducing a clotting response, so that blood can no longer enter the aneurysm. While embolization coils enable minimally invasive treatment of brain aneurysms, the devices carry significant risks, including mechanical failure and patient interaction problems. This study quantitatively characterizes adverse events attributed to neurovascular embolization coils. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was mined using a computer algorithm created using the Pandas Python module. A total of 17,992 reports of deaths, injuries, and malfunctions were retrieved and analyzed using the algorithm. The results reveal that the most common adverse events for embolization coils are unidentified problems, activation failure, separation/detachment, positioning failure, and advancing difficulties. The most frequently reported adverse patient outcomes are no consequences, rupture, and hemorrhage. The delay between event date and report date was also characterized. Deaths exhibited an average reporting delay of 69.21 days, injuries exhibited an average reporting delay of 65.35 days, and malfunctions exhibited an average reporting delay of 35.52 days. Finally, injury and malfunction narratives were searched for terms indicative of patient death; this analysis revealed that 1.7% of injuries and 0.29% of malfunctions were misreported.