RESUMO
Since its Food and Drug Administration approval in January 2007, the Angiosculpt scoring balloon catheter has been widely utilized in severely calcified stenotic vascular lesions. We sought to characterize the complication rates, failure modes, and outcomes associated with the Angiosculpt catheter. Using queried events from October 2013 to December 2020 from the Food and Drug Administration Manufacturer and User Facility Device Experience database, we analyzed the Angiosculpt scoring balloon catheter complication rates and mode of failure. A total of 248 complications were reported. Most reported complications occurred in the superficial femoral artery (SFA) (19.4%, nâ¯=â¯48), followed by the left anterior descending artery (8.1%, nâ¯=â¯20). Severe vessel calcifications were reported in (26.6%, nâ¯=â¯66) of the complications. Most complications occurred with damage to the device, such as tip break (44.8%, nâ¯=â¯111) and balloon rupture (26.6%, nâ¯=â¯66). Some complications were due to difficulties in the withdrawal of the catheter (23.8%, nâ¯=â¯59). Balloon rupture is observed at a significantly higher rate amongst calcified vessels (60.6% vs 14.8%), Pâ¯=â¯< 0.001, and in cases involving the SFA (39.4% vs 11.3%), Pâ¯=â¯< 0.001. All-cause complications in calcified vessels are associated with the SFA (39.4% vs 12.5%), Pâ¯=â¯< 0.001, and left anterior descending artery (16.7% vs 5.1%), Pâ¯=â¯< 0.001. The Angiosculpt scoring balloon catheter has a relatively low complication rate. Most complications were associated with a device tip break, balloon rupture, and difficulties in withdrawal in severely calcified vessels.