Table 3.

Case descriptions for previously under-recognized Melody® valve post-procedural adverse events

	Time after implant (mos)	Event description and circumstances	Outcome	Source
Type III stent fracture (complete fracture with stent fragment embolization)	7	Location of fragment not noted	Surgical valve removal	MAUDE
	35	Fragment embolized to right ventricle apex	Details not provided	MAUDE
	12	Fragment embolized to right ventricle apex	Fragment left in place, 2nd trans-catheter valve implanted	MAUDE
	24	Fragment embolized to branch pulmonary artery	Fragment retrieved, 2nd trans-catheter valve implanted	MAUDE
	98	Fragment embolized to left lung	No intervention required	MAUDE
Device erosion / aortopulmonary fistula	0.75	Valve erosion into ascending aorta in patient with history of Ross procedure, presented with heart failure	Surgical valve removal	Taggart (2013) Congenital Heart Disease
	0.75	Fistula between aortic root and conduit in patient with history of interrupted aortic arch repair	Surgical valve removal	Peer (2014) Journal of Thoracic and Cardiovascular Surgery
	16	Valve erosion into ascending aorta with shunt causing “severe” heart failure	Surgical valve removal	MAUDE
	36	Valve erosion into ascending aorta in a patient with history of Ross-Konno operation, presented with heart failure	Surgical valve removal	MAUDE
Late coronary obstruction	0.2	LAD obstruction presenting 5 days after implant; intra-procedural coronary compression resolved with nitroglycerin administration and was attributed to vasospasm	Surgical valve removal	Biermann (2012) Thoracic and Cardiovascular Surgeon
	3	Late right coronary artery dissection and obstruction after exercise, felt to be related to increased cardiac output	Surgical valve removal and right coronary artery re-implantation	Deghani (2015) Catheterization and Cardiovascular Interventions