The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism

Table 3

Selected complications of retrievable IVC filters reported in three systematic reviews and two analyses of the FDA MAUDE database.

Complication	Reports
Filter fracture; Structural failure of the filter leading to fragmentation	Reported in specific systematic reviews
	(i) 0.5% (50/9509 patients) [9]
	(ii) 6 of 14 articles reported fracture rates >10% [7]
	Percentage of reported MAUDE complications
	(i) 22.0% (2011) [3]
	(ii) 23.9% (2014) [34]
Filter migration; Movement >2 cm above or below initial placement	Reported in specific systematic reviews
	(i) 1.3% (35/2716 patients) [3]
	(ii) 1.4% (160/11,679) [9]
	(iii) 4 of 14 articles reported migration rates >10% [7]
	Percentage of reported MAUDE complications
	(i) 22.0% (2011) [3]
	(ii) 12.1% (2014) [34]
Filter perforation; Penetration of a filter component >3 mm of vena cava wall	Reported in specific systematic reviews
	(i) 5.4% (379/7001 patients) [9]
	(ii) 5 of 14 articles reported perforation rates >20% [7]
	Percentage of reported MAUDE complications
	(i) 20% (2011) [3]
	(ii) 15.4% (2014) [34]
Filter tilt; An angulation >15 degrees from the long axis of the vena cava	Reported in specific systematic reviews
	(i) 7.7% (798/10,348) [9]
	(ii) 5 of 14 articles reported tilting rates >10% [7]
	Percentage of reported MAUDE complications
	(i) 3.9% (2014) [34]
Deep vein thrombosis	Reported in specific systematic reviews
	(i) 5.4% (69/1277 patients) [3]
	(ii) 7.1% (362/5092 patients) [9]
IVC thrombosis/stenosis	Reported in specific systematic reviews
	(i) 2.8% (116/4078 patients), 37 studies [3]
	(ii) 3.9% (345/8788 patients), 103 studies [9]
	Percentage of reported MAUDE complications
	(i) 2.3% (2014) [34]

Sources: Systematic reviews: Angel et al. (2010) [3], Deso et al. (2016) [7], Jia et al. (2018) [9]; MAUDE analyses: Andreoli et al. (2014) [34], Angel et al. (2010) [3]