Continued controversy regarding adverse events after Amplatzer septal device closure: Mass hysteria or tip of the iceberg?

Journal of Thoracic and Cardiovascular Surgery

Volumn 142, Issue 1, 2011, Pages 222-223

  Dibardino, Daniel J ^a,c   Mayer Jr , John E ^b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b BOSTON CHILDREN S HOSPITAL   (United States)

^c 5144 CVC/SPC 5864   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EROSION; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HEART ATRIUM EROSION; HEART TAMPONADE; HUMAN; MORTALITY; NOTE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; SEPTAL OCCLUDER; THORAX PAIN; DATA BASE; DEVICE EMBOLIZATION; HEART PERFORATION; MEDICAL DEVICE COMPLICATION; MEDICAL DEVICE EROSION; SURGICAL MORTALITY;

EID: 79959332254     PISSN: 00225223     EISSN: 1097685X     Source Type: Journal    
DOI: 10.1016/j.jtcvs.2011.04.014     Document Type: Editorial

References (3)

1. N.W. Taggart, J.A. Dearani, and D.J. Hagler Later erosion of an Amplatzer septal occluder device 6 years after placement J Thorac Cardiovasc Surg 142 2011 221 222
2. D.J. DiBardino, D.B. McElhinney, A.K. Kaza, and J.E. Mayer Jr. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database J Thorac Cardiovasc Surg 137 2009 1334 1341
3. D.J. DiBardino Clarification of statements made regarding investigation into Amplatzer device complication incidence and comparison with the Society of Thoracic Surgery database J Thorac Cardiovasc Surg 138 2009 784 785