Introduction/Purpose We report on data in the Manufacturer and User Facility Device Experience (MAUDE) database for Neuroform (Boston Scientific), Enterprise (Cordis), and Pipeline (Covidien) devices with a focus on a 6-month period.
Materials and Methods All events reported from May 31, 2011 to December 30, 2011 in the MAUDE database were collected for Neuroform, Enterprise, and Pipeline devices. Results were analyzed for extent of injuries and device malfunctions reported.
Results In summary, the combined Neuroform and Enterprise MAUDE reports showed that there were 73 events reported between May 31 and December 30, 2011. Four deaths were reported during the time period examined (5% of reports); of these, three reports stated that event date was unknown and one was reported as not device-related. SAH developed as a complication during Enterprise-stent assisted embolization of one aneurysm, and the patient subsequently died. Injuries described in the reports included two post-treatment bleeds (2.7% of reports), 10 occlusions (13.7%) and four SAH (5% of reports), one of which was associated with disability and one of which is associated with death of unknown event date. Device malfunctions were indexed in 41% of the reports, including four which were described as catheter or strut separation/breaks (5% of reports), 14 were delivery system failures (19% of reports) and four were fractures (5% of reports). The Pipeline MAUDE reports showed that there were 71 events reported during May 31 to December 30, 2011. Thirteen deaths were reported during the time period examined (18% of reports); eight deaths involved peri-procedural or post-treatment bleeds (62% of reported deaths). Injuries described in the reports include 12 post-treatment bleeds (17% of reports) and four SAHs (6% of reports), all of which are associated with death. The number of device malfunctions reported includes 38 failures to deploy (54% of reports) with associated 29 ballooning procedures (41% of reports) and nine broken push wires (13% of reports).
Conclusion For the 6-month period examined, events such as death, serious injury, and device malfunctions were reported in the MAUDE database. Even though the total number of reports comparing Neuroform/Enterprise and Pipeline were comparable, number of deaths related to Pipeline were more than three times higher. Due to lack of data regarding total number of patients treated during the time period examined, adverse event occurrence rates across devices cannot be compared. Further data and discussion are warranted to understand these initial observations.
Competing interests None.