UK vigilance guidance
This article was originally published in The Gray Sheet
Executive Summary
Stent adverse incident reports should be directed to the UK Medical Devices Agency by manufacturers knowing of any implant deterioration or malfunction, or whether the implant has been recalled for medical reasons, among other criteria, according to a guidance issued by the British regulatory agency. Reportable events include premature stent dislodgement, unsuccessful stent deployment, and loss of stent patency