Hear no evil, see no evil, speak no evil: Postmarket monitoring, underreporting, and estimating the prevalence of endograft-related adverse events

Journal of Vascular Surgery

Volumn 35, Issue 6, 2002, Pages 1299-1300

  Chaikof, Elliot L ^a,b  

^a Emory University School of Medicine ^*

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANEURYSM RUPTURE; AORTA ANEURYSM; BLOOD VESSEL GRAFT; BONE GRAFT; CORONARY STENT; DEVICE; ENDOVASCULAR SURGERY; FOLLOW UP; HEART VALVE BIOPROSTHESIS; HUMAN; MEDICAL LITERATURE; MORTALITY; NOTE; POSTMARKETING SURVEILLANCE; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SAFETY; VASCULAR SURGERY; BLOOD VESSEL PROSTHESIS; FOOD AND DRUG ADMINISTRATION; STENT; UNITED STATES;

BLOOD VESSEL PROSTHESIS; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; STENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0036597535     PISSN: 07415214     EISSN: None     Source Type: Journal    
DOI: 10.1067/mva.2002.123759     Document Type: Article

References (6)

1. Bernhard VM, Mitchell RS, Matsumura JS, Brewster DC, Decker M, Lamparello P, et al. Ruptured abdominal aortic aneurysm following endovascular repair. J Vasc Surg. In press 2002.
2. Harris PL, Vallabhaneni SR, Desgranges P, Becquemin JP, van Marrewijk C, Laheij RJ. Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience. J Vasc Surg 2000;32:739-49.
3. Becker GJ, Kovacs M, Mathison MN, Katzen BT, Benenati JF, Zemel G, et al. Risk stratification and outcomes of transluminal endografting for abdominal aortic aneurysm: 7-year experience and long-term follow-up. J Vasc Intervent Radiol 2001;12:1033-46.
4. Zarins CK, White RA, Moll FL, Crabtree T, Bloch DA, Hodgson KJ, et al. The AneuRx stent graft: four-year results and worldwide experience 2000. J Vasc Surg 2001;33(Suppl 2):S135-45.
5. Lifeline Registry of Endovascular Repair Steering Committee. Lifeline Registry: collaborative evaluation of endovascular aneurysm repair. J Vasc Surg 2001;34:1139-46.
6. The role of clinical data in postmarket surveillance of cardiovascular devices. FDA workshop summary [internet]. Available at: www.fda. gov/cdrh/postsurv/postscvwork.html.