title: 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.
abstract: OBJECTIVE
  Amplatzer (AGA Medical Corporation, Plymouth, Minn) septal and vascular occluder devices have significantly altered the care of patients with congenital heart disease. The relative frequency and consequence of complications resulting from the attempted placement of such devices, however, have not been well assessed. The purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure.
  
  
  METHODS
  The US Food and Drug Administration Manufacturer and User Facility Device Experience database was quarried for all adverse events for Amplatzer septal occluder devices, which were categorized and analyzed with particular emphasis on management and outcome. The Society of Thoracic Surgery database was likewise quarried for the same data regarding atrial septal defect closures over a contemporaneous time period. By using a literature-derived denominator for total Amplatzer implant numbers, the results of the 2 therapies were compared.
  
  
  RESULTS
  Since July 1, 2002, 223 adverse events in patients undergoing Amplatzer atrial septal defect closure were submitted to the Food and Drug Administration, resulting in 17 deaths (7.6%) and 152 surgical rescue operations (68.2%). Society of Thoracic Surgery data demonstrated 1537 primary operations with 2 deaths (0.13%) and 6 reoperations (0.39%). By extrapolating on published estimates of Amplatzer implantation to provide an implant denominator (n = 18,333), there was no difference between overall mortality for surgical (0.13%) and device closure (0.093%, P = .649). Rescue operation for device adverse events (0.83%) was 2.1 times more likely than reoperation for surgical closure (0.39%, P = .063). Mortality per adverse event was higher for device closure (7.6%) than for surgical closure (1.2%, P = .004), and the need for surgery per adverse event was higher for device closure (68.2%) than for surgical closure (3.6%, P < .001). The mortality for surgical management of a device adverse event (2.6%) was 20-fold higher than for primary elective atrial septal defect closure (0.13%, P < .0001).
  
  
  CONCLUSIONS
  Overall crude mortality for device and surgical closure atrial septal defect closure is equivalent, and the need for subsequent operation (surgical rescue) is more common in patients undergoing device closure than reoperation is in patients undergoing surgical closure. Complications from device closure tend to be serious and most often require urgent or emergency operative management, whereas the mortality for surgical management of a device complication appears higher than that of elective atrial septal defect closure. Further information is required in the form of postmarketing surveillance, such as a mandatory user registry with periodic end-user notification.
authors.affiliation: Department of Cardiac Surgery, Children's Hospital Boston, Harvard Medical School, Boston, Mass 02215, USA. ddibardino@partners.org
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: DiBardino
authors.forename: Doff B
authors.initials: DB
authors.lastname: McElhinney
authors.forename: Aditya K
authors.initials: AK
authors.lastname: Kaza
authors.forename: John E
authors.initials: JE
authors.lastname: Mayer
mesh_terms: D006348:Cardiac Surgical Procedures / Q000295:instrumentation; D016208:Databases, Factual; D004868:Equipment Failure; D005548:Foreign-Body Migration; D006335:Heart Injuries / Q000209:etiology; D006343:Heart Septal Defects / Q000601:surgery*; D006801:Humans; D019736:Prostheses and Implants / Q000009:adverse effects*; D012955:Societies, Medical; D013903:Thoracic Surgery; D013923:Thromboembolism / Q000209:etiology; D014481:United States; D014486:United States Food and Drug Administration