The Journal of Thoracic and Cardiovascular Surgery
Volume 137, Issue 6 , Pages 1334-1341 , June 2009

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

  • Daniel J. DiBardino, MD

      Affiliations

    • Department of Cardiac Surgery, Children' s Hospital Boston, Harvard Medical School, Boston, Mass
    • Corresponding Author InformationAddress for reprints: Daniel J. DiBardino, MD, Cardiac Surgery, Children' s Hospital Boston, 300 Longwood Avenue, Boston, MA 02215.
    • ,
  • Doff B. McElhinney, MD

      Affiliations

    • Department of Cardiology, Children's Hospital Boston, Harvard Medical School, Boston, Mass
    • ,
  • Aditya K. Kaza, MD

      Affiliations

    • Department of Cardiac Surgery, Children' s Hospital Boston, Harvard Medical School, Boston, Mass
    • ,
  • John E. Mayer Jr., MD

      Affiliations

    • Department of Cardiac Surgery, Children' s Hospital Boston, Harvard Medical School, Boston, Mass

Received 25 May 2008 ,Revised 26 December 2008 ,Accepted 16 February 2009.

  • Image Result

    Histogram demonstrating the number of AEs involving the Amplatzer (AGA Medical Corporation, Plymouth, MN) septal occluder reported to the USFDA between January 2002 and December 2006. AE, Adverse even

    Histogram demonstrating the number of AEs involving the Amplatzer (AGA Medical Corporation, Plymouth, MN) septal occluder reported to the USFDA between January 2002 and December 2006. AE, Adverse event.

 Read at the Eighty-eighth Annual Meeting of the American Association for Thoracic Surgeons, May 11–14, 2008, San Diego, California.

PII: S0022-5223(09)00355-9

doi: 10.1016/j.jtcvs.2009.02.032

The Journal of Thoracic and Cardiovascular Surgery
Volume 137, Issue 6 , Pages 1334-1341 , June 2009

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