Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016.
Mohammad-Ali JazayeriVenkat VuddandaMohit K TuragamValay ParikhMadhav LavuDonita AtkinsMatthew EarnestLuigi Di BiaseSanghamitra MohantyDavid WilberYeruva Madhu ReddyDhanunjaya R LakkireddyPublished in: Journal of cardiovascular electrophysiology (2017)
MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.
Keyphrases
- left atrial appendage
- end stage renal disease
- drug administration
- electronic health record
- newly diagnosed
- atrial fibrillation
- ejection fraction
- chronic kidney disease
- peritoneal dialysis
- emergency department
- transcription factor
- minimally invasive
- machine learning
- adverse drug
- big data
- catheter ablation
- radiofrequency ablation
- patient reported
- long term care