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The risk of cardiac erosion with commercially available atrial septal defect occluders has led to changes in device labeling and implantation technique. Previous reports have described publicly-available data on erosion events but have not included recent experience.
The FDA Manufacturer and User Facility Device Experience (MAUDE) was queried for events related to Atrial Septal Occluders (ASO), Multifenestrated Septal Occluders (MFO) (both St. Jude Medical, St. Paul, MN), and Helex Occluders (HSO) (W.L. Gore, Newark, DE). Two investigators reviewed and classified each event by type, device, and size.
Between 2012 and 2015, a total of 382 event were reported for ASO and MFO and 104 for HSO. The most frequent event reported was device embolization (57% of events for ASO/MFO and 39% for HSO). There were no reported erosion events for HSO, 4 for MFO and 46 for ASO. The median size ASO with erosion was 20±6 mm, 2 cases involved implantation of 2 adjacent ASO devices, and death was described in association with erosion in 4 cases. 43 erosions occurred in on-label ASO usage with use indications not documented in the remaining cases. 39 of 50 erosions are documented to have been reviewed by the manufacturer’s erosion board, with confirmation of erosion in 38 reports. Over the analyzed period, there was a decline in total event and erosion reports (Figure).
Erosion events with ASO/MFO devices persist in this public database but have declined in number since earlier reports on their incidence. This may reflect limitations of the voluntary database or the effect of new recommendations for implantation and monitoring.