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Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database.

Publication ,  Journal Article
Delaney, JW; Li, JS; Rhodes, JF
Published in: Congenit Heart Dis
2007

OBJECTIVE: To summarize major complications and outcome for patients receiving percutaneous closure of atrial septal communications. DESIGN: The Medline database and the United States Food and Drug Administration manufacturer and user facility device experience databases (MAUDE) were searched for reports related to complications with atrial septal occluding devices. The medical literature documenting complication rates for these devices were reviewed and summarized. The MAUDE database complication reports were compared with those reported in the medical literature using national implant estimates. OUTCOME: The MAUDE database correlated in the type of complications most frequently encountered with each device. However, based on estimated total implant numbers, there is a higher incidence of major complications, including death. AGA devices had a 0.3% erosion/perforation rate with a higher morbidity and mortality (29%) than previously reported. NMT devices had a lower incidence of erosion/perforation rate of 0.05%. Embolization rates for the NMT devices were also lower than published European studies, possibly reflecting the US restriction of the device for closure of patent foramen ovale. Thrombus was more frequently encountered on the NMT device. Both AGA and NMT devices have been shown to be safe and effective alternatives to cardiac surgery. The MAUDE database correlated, with a very low overall complication rate, but showed a higher estimated major complication rate than the medical literature. These data demonstrate the difficulty in quantifying rare complications in the premarketing analysis and the obligation providers have to report and evaluate complications through vigilant postmarketing surveillance.

Duke Scholars

Published In

Congenit Heart Dis

DOI

EISSN

1747-0803

Publication Date

2007

Volume

2

Issue

4

Start / End Page

256 / 264

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Thrombosis
  • Prostheses and Implants
  • MEDLINE
  • Humans
  • Heart Septal Defects, Atrial
  • Health Care Sector
  • Equipment Failure
  • Embolism
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Delaney, J. W., Li, J. S., & Rhodes, J. F. (2007). Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database. Congenit Heart Dis, 2(4), 256–264. https://doi.org/10.1111/j.1747-0803.2007.00107.x
Delaney, Jeffrey W., Jennifer S. Li, and John F. Rhodes. “Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database.Congenit Heart Dis 2, no. 4 (2007): 256–64. https://doi.org/10.1111/j.1747-0803.2007.00107.x.
Delaney, Jeffrey W., et al. “Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database.Congenit Heart Dis, vol. 2, no. 4, 2007, pp. 256–64. Pubmed, doi:10.1111/j.1747-0803.2007.00107.x.
Journal cover image

Published In

Congenit Heart Dis

DOI

EISSN

1747-0803

Publication Date

2007

Volume

2

Issue

4

Start / End Page

256 / 264

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Thrombosis
  • Prostheses and Implants
  • MEDLINE
  • Humans
  • Heart Septal Defects, Atrial
  • Health Care Sector
  • Equipment Failure
  • Embolism