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.

References 

  1. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/default.htm.
  2. GraphPad Software Web site. Available at: www.graphpad.com.
  3. Delaney JW, Li JS, Rhodes JF. Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the MAUDE database. Congenit Heart Dis. 2007;2:256–264
  4. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv. 2004;63:496–502
  5. Levi DS, Moore JW. Embolization and retrieval of the Amplatzer septal occluder. Catheter Cardiovasc Interv. 2004;61:543–547
  6. O'Shea JC, Kramer JM, Califf RM, Peterson ED. Sharing a commitment to improve cardiovascular devices. Part I: Identifying holes in the safety net. Am Heart J. 2004;147:977–984
  7. Peterson ED, Hirshfeld JW, Ferguson TB, Kramer JM, Califf RM, Kessler LG. Sharing a commitment to improve cardiovascular devices. Part II: Sealing holes in the safety net. Am Heart J. 2004;147:985–990
  8. Gross TP, Kessler LG. Medical device vigilance at FDA. Stud Health Technol Inform. 1996;28:17–24
  9. Chessa M, Carminati M, Butera G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol. 2002;39:1061–1065
  10. Krumsdorf U, Ostermayer S, Billinger , et al. Incidence and clinical course of thrombus formation on atrial septal defect and patent foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol. 2004;43:302–309
  11. Anazai H, Child J, Natterson , et al. Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices. Am J Cardiol. 2004;93:426–431
  12. Raghu A, Kawalsky D, Feldman M. Embolitic stroke due to a left atrial thrombus two years after placement of an atrial septal defect closure device. Am J Cardiol. 2006;98:1294–1296
  13. Butera G, Carminati M, Chessa M, et al. CardioSEAL/STARflex versus Amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defects. Am Heart J. 2004;148:507–510
  14. Wang JK, Tsai SK, Wu MH, Lin MT, Lue HC. Sort-and intermediate-term results of transcatheter closure of atrial septal defect with the Amplatzer septal occluder. Am Heart J. 2004;148:511–517
  15. Hong TE, Thaler D, Brorson J, Heitschmidt M, Hijazi ZM. Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the Amplatzer PFO occluder: initial and intermediate-term results of the U.S Multicenter Clinical Trial. Catheter Cardiovasc Interv. 2003;60:524–528
  16. Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K. Comparison between Transcather and surgical closure of secundum atrial septal defect in children and adults. J Am Coll Cardiol. 2002;1836–1844
  17. Grayburn PA, Schwartz B, Anwar A, Hebeler RF. Migration of an Amplatzer septal occluder device for closure of atrial septal defect into the ascending aorta with formation of an aorta-to-right-atrial fistula. Am J Cardiol. 2005;96:1607–1609
  18. Preventza O, Sampath-Kumar S, Wasnick J, Gold JP. Later cardiac perforation following transcatheter atrial septal defect closure. Ann Thorac Surg. 2004;77:1435–1437
  19. Maimon MS, Ratnapalan S, Do A, Kirsh JA, Wilson GJ, Benson LN. Cardiac Perforation 6 weeks after percutaneous atrial septal defect repair using an Amplatzer septal occluder. Pediatrics. 2006;118:e1572–e1575
  20. Chun DS, Turrentine MW, Moustapha A, Hoyer MH. Development of aorta-to-right atrial fistula following closure of secundum atrial septal defect using the Amplatzer septal occluder. Catheter Cardiovasc Interv. 2003;58:246–251
  21. Cecconi M, Quarti A, Bianchini , et al. Later cardiac perforation after transcatheter closure of patent foramen ovale. Ann Thorac Surg. 2006;81:e29–e30
  22. Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J. Cardiac perforation after device closure of atrial septal defects with Amplatzer septal occluder. J Am Coll Cardiol. 2005;45:1213–1218

 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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