Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

ABSTRACT:

Background

The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).

Methods

We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a compos

SUBMITTER: Resnic FS 

PROVIDER: S-EPMC6145132 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature