1433 A 13 Year Review of Uterine Endometrial Ablation Device Events Using Categorization of Reports to the Manufacturer and User Facility Device Experience (Maude) Data Base

Abstract

Study Objective Usefully categorize reports on endometrial ablation device events using the FDA MAUDE database. Design The FDA MAUDE database was reviewed using brand name searches: Novasure, Genesys HTA, Thermachoice, Minerva, and HerOption. Reported events were categorized as follows: Type I , non-injury equipment malfunction; Type II , an injury event not requiring hospitalization; Type III , an injury requiring hospitalization. Setting 13-year FDA MAUDE database review (2005-2018). Patients or Participants N/A. Interventions N/A. Measurements and Main Results 1518 MAUDE reports were categorized as follows: Novasure: Type I: 92/550 (16.7%), Type II: 273/550 (49.6%), Type III: 185/550 (33.6%); Genesys HTA: Type I: 140/432(32.40%), Type II: 259/432 (58.1%), Type III: 42/432 (9.49%); Thermachoice: Type I: 315/466 (67.60%), Type II: 78/466 (16.74%), and Type III: 73/466 (15.67%); Minerva: Type I: 13/56 (23.21%), Type II: 9/56 (16.07%), and Type III: 34/56 (60.71%); Her Option: Type I: 4/14 (28.57%), Type II: 0 (0%), and Type III:10/14 (71.43%). Novasure, Minerva, and Her Option had a greater percent of events due to bowel injury while Genesys HTA and Thermachoice had a greater percent of events due to vaginal/cervical/external thermal injuries. Over 50% of HTA Geneysis events were due to vaginal/cervical/external thermal injuries while greater than 50% of Novasure events were due to uterine perforation. Thermachoice had greater than 60% of events due to balloon rupture device malfunction. Conclusion The MAUDE database serves as a valuable tool for physicians to evaluate the safety and possible complications from existing and new technologies. Categorizing events as described here may improve clinicians’ ability to interpret MAUDE data. Large differences in report type were noted between brands of endometrial ablation devices. The percentage of Type III events by device were highest for HerOption, Minerva, and Novasure. Caution must be made when interpreting the data from the MAUDE database due to potential subjective and incomplete narrative, lack of outcome details, and erroneous or duplicate submissions.