Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan.

Abstract

Signal detection is essential for identifying potential safety issues with drugs and medical devices. Change point analysis (CPA) detects changes in longitudinal data for a medical device without incorporating comparisons with other devices. This study investigated the temporal relationship between endoleak reports for aortic stent grafts identified using CPA and the issuance of the "Pharmaceuticals and Medical Devices Agency (PMDA) Alert for Proper Use of Medical Devices" in Japan. Device malfu