Post-market surveillance to detect adverse events associated with Melody® valve implantation.

ABSTRACT:

Objective

The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.

Background

In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.

Methods

We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemptio

SUBMITTER: Hill KD 

PROVIDER: S-EPMC5425318 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature