Disease-specific guidelines for reporting adverse events for peripheral vascular medical devices

Abstract

This reporting standards document has been created in two parts. Part One summarized existing multinational governmental and nongovernmental guidelines and regulations for reporting adverse events that occur with the use of medical devices for peripheral vascular interventions. 1 Other important components required for the safe and proper conduct of a clinical trial evaluating vascular devices were also summarized. The aim of the current document is the same: to achieve greater reporting consistency between clinicians, investigators, specialties, institutions, and investigational studies. In Part Two, the reporting of adverse events is organized by disease process. Formal guidelines were not specified in Part One and definitions were in large part general. Rather than the general suggestions and definitions included in Part One, the recommendations in Part Two are broadly grouped by vascular disease system: arterial and venous. Within each system, recommendations are included specific to an individual disease process, for example, carotid stenosis, aortic aneurysms, and lower extremity occlusive disease.

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

“…Other groups have developed guidelines for the reporting of adverse events in usual practice and in the context of clinical trials to achieve greater reporting consistency between clinicians, investigators and institutions. 20 At this level there is a potential role for advocacy and stewardship by professional societies.…”

Outcome-based anatomic criteria for defining the hostile aortic neck

“…Imaging end points were measured and reported using the methodology from the Society for Vascular Surgery reporting standards guideline documents where end point definitions were specificed. [12][13][14][15] Aortic diameters were measured as the average diameter of the centerline reformatted aortic adventitia-toadventitia contour. Circularity was not assumed; rather, any deviation from perfect circularity was taken into account with an electronically traced aortic contour on a plane orthogonal to the aortic centerline.…”

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease

“…However, the preference is for long-term (5- they are related to the device or to the procedure. 86,87 Intervention is defined as the introduction of wires, catheters, or other endovascular devices to a site beyond the access artery, with or without an associated endovascular procedure, such as vessel recanalization, angioplasty, atherectomy, or deployment of a stent or stent graft. Complications should be recorded as being acute (#30 days), subacute (between 30 days and 12 months) and late (>12 months).…”