. Author manuscript; available in PMC: 2018 Aug 1.

Published in final edited form as: Cardiol Young. 2016 Nov 10;27(6):1090–1097. doi: 10.1017/S1047951116002092

Table 2.

Melody® valve post-procedural adverse events

	U.S. Melody^® valve trials (N=244 implants)	Retrospective literature reports	Case reports	MAUDE medical device reports
Stent Fracture	57 (23.4%)	116	-	94
Type II (Loss of structural integrity)	26 (10.6%)	22	-	35
Type III (with particle embolization)	1 (0.4%)	-	-	5
Endocarditis	17 (7%)	63	13	28
Valve dysfunction without stent fracture¹	-	-	-	37
Device erosion	-	-	2	2
Late coronary compression²	-	-	2	-

Including stenosis or insufficiency,

RCA compression identified 5 days and 3 months after implant when patients presented with myocardial infarction