Complications and Failure Modes of Coronary Embolic Protection Devices: insights from the MAUDE database
Presenter
Michael S Megaly, M.D., FSCAI, St John Hospital & Medical Center, Tulsa, OK
Michael S Megaly, M.D., FSCAI, St John Hospital & Medical Center, Tulsa, OK, Ramez Morcos, M.D., Florida Atlantic University, Boca Raton, FL, Charl Khalil, MD, Cook County Hospital, Chicago, IL, Santiago Garcia, MD, FSCAI, The Christ Hospital Health Network, Cincinnati, OH, Babar B Basir, DO, FSCAI, Henry Ford Health System, Detroit, MI, Brijeshwar S. Maini, M.D., Tenet Healthcare, Boca Raton, FL, Houman Khalili, M.D., FSCAI, Memorial Healthcare System, Hollywood, FL, M. Nicholas Burke, M.D., FSCAI, Minneapolis Heart Institute® - Abbott Northwestern Hospital, Minneapolis, MN, Khaldoon Alaswad, M.D., FSCAI, Henry Ford Hospital, Detroit, MI and Emmanouil S. Brilakis, MD, PhD, FSCAI, Minneapolis Heart Institute® - Abbott Northwestern Hospital, Edina, MN
Keywords: Embolic Protection
Background:
There is limited data on complications associated with use of coronary embolic protection devices (EPDs).
Methods
:
We queried the MAUDE database between November 2010 and November 2020 for reports on coronary EPDs.
Results
:
We retrieved 119 reports on coronary EPD failure (Spider FX n=33, Filterwire EZ n=86) EPDs, most of which (78.2%) occurred during saphenous vein graft intervention. The most common mode of failure was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5% with Spider Fx vs. 29.1% with the Filterwire) and failure to recapture (9.1% vs. 2.1%, p=0.03) were more commonly the modes of failure reported with the Spider-FX, whereas failure to deploy the filter (0% vs. 10.5%, p=0.05) was less common. Surgical retrieval was required more frequently with Spider-FX (21.2% vs. 7%, p=0.02) compared with Filterwire EZ.
Conclusions:
The most common modes of failure of coronary EPDs include failure of retrieval (49.6%), followed by the filter fracture (28.6%). Improvements in EPDs design and retrieval tools are needed to optimize the use and minimize the risk of complications.
