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Major Complications and Failure Modes of the Angiosculpt Scoring Balloon Catheter: Analysis of the MAUDE Database
John S Dayco1, Heba Osman1, Talal Almas2
1Wayne State University, Detroit Medical Center, MI.
Insights
The Angiosculpt scoring balloon catheter shows a low complication rate for treating calcified vascular lesions. Most issues involved device tip breaks or balloon ruptures, particularly in superficial femoral artery interventions.
Area of Science:
- Cardiovascular Interventions
- Medical Device Safety
- Vascular Surgery
Background:
- The Angiosculpt scoring balloon catheter is FDA-approved for treating calcified vascular lesions.
- Understanding its complication profile is crucial for safe clinical application.
Purpose of the Study:
- To characterize complication rates, failure modes, and outcomes of the Angiosculpt catheter.
- To analyze device performance in severely calcified stenotic vascular lesions.
Main Methods:
- Analysis of Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database events from October 2013 to December 2020.
- Investigated 248 reported complications associated with the Angiosculpt catheter.
Main Results:
- Most complications occurred in the superficial femoral artery (SFA) and left anterior descending artery.
- Device damage (tip break, balloon rupture) and withdrawal difficulties were primary issues.
- Balloon rupture rates were significantly higher in calcified vessels (60.6%) and SFA interventions (39.4%).
Conclusions:
- The Angiosculpt catheter demonstrates a relatively low overall complication rate.
- Complications are predominantly linked to device integrity and withdrawal challenges in calcified lesions, especially within the SFA.
Abstract:
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%, n = 48), followed by the left anterior descending artery (8.1%, n = 20). Severe vessel calcifications were reported in (26.6%, n = 66) of the complications. Most complications occurred with damage to the device, such as tip break (44.8%, n = 111) and balloon rupture (26.6%, n = 66). Some complications were due to difficulties in the withdrawal of the catheter (23.8%, n = 59). Balloon rupture is observed at a significantly higher rate amongst calcified vessels (60.6% vs 14.8%), P = < 0.001, and in cases involving the SFA (39.4% vs 11.3%), P = < 0.001. All-cause complications in calcified vessels are associated with the SFA (39.4% vs 12.5%), P = < 0.001, and left anterior descending artery (16.7% vs 5.1%), P = < 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.
