Analysis of the U.S. Food and Drug Administration MAUDE Database for Adverse Events Involving Amplatzer™ Septal Occluder Devices and Comparison to STS Congenital Cardiac Surgery Database
Daniel J. Dibardino, Doff B. McElhinney, Aditya K. Kaza, John E. Mayer; Harvard Medical School, Boston, MA
Comment on this Abstract
Objective: Amplatzer septal occluder devices have significantly altered the care of patients with congenital heart disease and are becoming standard care in many institutions. The incidence, nature and consequence of complications resulting from attempted device placement, however, have not been well-assessed. The purpose of this study was to utilize large available databases to generate meaningful data.
Methods: The United States Food and Drug Administration (FDA) on-line database for device-related adverse events was queried for brand name search field “Amplatzer” and all events concerning closure of the atrial septum were recorded and analyzed. The Society of Thoracic Surgeons (STS) Congenital Cardiac Surgery Database was likewise queried for surgical atrial septal closure over the same time interval such that comparison could be made.
Results: The first Amplatzer adverse event report was filed to the FDA on 1/24/02 and a total of 218 reports are now available. Attempts to obtain the total number of devices placed since the first report were unsuccessful. There were 16 deaths among the 218 complications (7.3%). The most common mode of failure was device embolization (n=111/218, 51%) with the left atrium being the most common site (n=25/111, 23%) and resulting in a 1.8% mortality (2/111). Cardiac erosion/rupture was the next most common (n=41/218, 19%), resulting in a 14.6% mortality (6/41). Attempts to manage complications in the catheterization lab were reported for 66 patients (30%) but were only successful in 29 patients with the remaining 37 requiring urgent/emergent operative management. An additional 105 patients were sent directly to surgery for a total of 142 urgent or emergent operations. STS data for the same time interval revealed 1,537 surgical atrial defect closures; there were 2 deaths (2/1,537, 0.13%) with 167 patients having any type of complication (167/1,537, 10.9%). Serious complications were rare; there were 2 re-operations for bleeding (0.13%), 4 other unplanned re-operations (0.26%), 2 persistent postoperative neurologic deficits (0.13%) and no acute renal failure. Median postoperative length of stay was 3 days.
Conclusion: Although the overall complication rate for device closure cannot be calculated, the available reported adverse events from device closure were more numerous than for surgical closure and resulted in more deaths. Device complications commonly necessitate urgent or emergent operation.
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