Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database.

ABSTRACT

BACKGROUND: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). METHODS: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). RESULTS: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode 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 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. CONCLUSIONS: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.