Real‐World Safety and Complications of the Boston Scientific AGENT Drug‐Coated Balloon From the FDA MAUDE Database
Real-world analysis of FDA MAUDE reports revealed frequent device malfunctions, mainly balloon rupture and shaft breakage, and patient complications such as angina, myocardial infarction, and coronary perforation. The off-label use for de novo lesions highlights the need for caution and further clinical investigation.
Authors
- Ron Waksman (ORCID: https://orcid.org/0000-0002-4063-9226)
- Sant Kumar (ORCID: https://orcid.org/0000-0001-5294-3682)
- Giorgio A. Medranda (ORCID: https://orcid.org/0000-0001-9804-3786)
- Toby Rogers (ORCID: https://orcid.org/0000-0002-6043-3137)
- Hayder Hashim (ORCID: https://orcid.org/0000-0003-2194-5428)
- Brian C. Case (ORCID: https://orcid.org/0000-0001-5355-9594)
- Nelson L. Bernardo (ORCID: https://orcid.org/0000-0002-0774-6118)
- Lowell F. Satler
- Itsik Ben‐Dor (ORCID: https://orcid.org/0009-0006-6026-9097)
Institutions
- Creighton University (US)
- MedStar Washington Hospital Center (US)
- Island Hospital (US)
Publication Details
- Journal
- Catheterization and Cardiovascular Interventions
- Published
- 2025-08-08
- DOI
- https://doi.org/10.1002/ccd.70082
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00