Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database

Figures & data

Figure 1 Study design and data collection.

Table 1 Reported Device-Related And Patient-Related Events By Device Type

	Total	Bolton Relay^® N=16	Medtronic Valiant^® N=184	Cook Zenith TX2^® N=11	Gore TAG^® N=123
	N	N (%)	N (%)	N (%)	N (%)
Endoleak	169	3 (1.8%)	101 (59.8%)	5 (3%)	60 (35.5%)
Dissection, penetrating aortic ulcer and intramural hematoma	67	5 (7.5%)	35 (52.2%)	3 (4.5%)	24 (35.8%)
Retrograde dissection	35	2 (5.7%)	20 (57.1%)	3 (8.6%)	10 (28.6%)
Neurologic	54	3 (5.6%)	15 (27.8%)	0	36 (66.7%)
Stroke	15	0	5 (33.3%)	0	10 (66.7%)
Paraplegia	37	3 (8.1%)	9 (24.3%)	0	25 (67.6%)
Unspecified	2	0	1 (50%)	0	1 (50%)
Technical device failure	45	1 (2.2%)	32 (71%)	3 (6.7%)	9 (20%)
Infections	18	0	6 (33%)	0	12 (66.7%)
Aorto-esophageal and aorto-bronchial fistula	11	0	3 (27.3%)	2 (18.2%)	6 (54.5%)
Migration	7	2 (28.6%)	2 (28.6%)	0	3 (42.9%)
Multiple complications	51	3 (5.9%)	12 (23.5%)	3 (5.9%)	33 (64.7%)

Table 2 Reported Device-Related And Patient-Related Events By Timing In Relation To Index Procedure

	Total	During Procedure	Early (<30 Days)	Late (>30 Days)	Unspecified Timing
	N	N (%)	N (%)	N (%)	N (%)
Endoleak	169	19 (11.2%)	31 (18.3%)	51 (30.2%)	68 (40.2%)
Dissection, penetrating aortic ulcer and intramural hematoma	67	16 (23.9%)	13 (19.4%)	22 (32.8%)	16 (23.9%)
Retrograde dissection	35	6 (17.1%)	11 (31.4%)	12 (34.3%)	6 (17.1%)
Neurologic	54	3 (5.6%)	38 (70.4%)	1 (1.9%)	12 (22.2%)
Stroke	15	0	13 (86.7%)	1 (6.7%)	1 (6.7%)
Paraplegia	37	3 (8.1%)	24 (64.9%)	0	10 (27.0%)
Unspecified	2	0	1 (50%)	0	1 (50%)
Technical device failure	45	45 (100%)	0	0	0
Infections	18	0	3 (16.7%)	8 (44.4%)	7 (38.9%)
Aorto-esophageal and aorto-bronchial fistula	11	1 (9.1%)	2 (18.2%)	6 (54.5%)	2 (18.2%)
Migration	7	4 (57.1%)	0	0	3 (42.9%)