Device-related patient outcomes for coronary stents: A MAUDE database analysis
Zihan Gao, Willie Lei, Eleanor Gao, Sujata Bhatia · 2024
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Description
Zihan Gao and co-authors mine the FDA's device incident database to compare how the three kinds of coronary stent fail patients in the real world. Bare-metal, drug-eluting, and bioresorbable stents each have trial records, but long-term device-caused harm is tracked poorly. Their 2024 study pulls a decade of MAUDE reports, from 2011 to 2020.
Nearly sixty-nine thousand adverse event reports sort into deaths, injuries, and malfunctions. Drug-eluting stents dominate the pile, reflecting their market share. Malfunctions are the most common event type of the three. The authors probe whether the mix of harms differs by stent family. Device regulators get a post-market mirror that clinical trials cannot provide.
Catalog record
| CREATOR | Zihan Gao, Willie Lei, Eleanor Gao, Sujata Bhatia |
|---|---|
| YEAR | 2024 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 20 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |