Longitudinal stent deformation: insights on mechanisms, treatments and outcomes from the Food and Drug Administration Manufacturer and User Facility Device Experience database

Abstract

Aims: Longitudinal stent deformation (LSD) is a recently described complication of PCI, but mechanisms contributing to its occurrence and associated clinical outcomes remain unclear. The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched to identify cases of LSD to gain insight into procedural and anatomical factors that predispose to this complication and associated clinical outcomes.

Methods and results: The MAUDE database is a voluntary international electronic reporting system whose aim is to capture major adverse events involving medical devices. Using defined search terms, we identified 57 unique cases of LSD ranging from 2004-2011. A significant increase in the reporting of LSD in the last two years was observed with most reported cases in stents based on the Element platform (90%). The lesions in which LSD was reported were complex (vessel calcification 26%; tortuosity 25%; long 28%; ostial disease 21%) and most frequently occurred following attempts to pass or withdraw secondary devices through a previously deployed stent (89% cases where mechanism identified). Adverse clinical outcomes including emergent cardiac surgery and acute and sub-acute stent thrombosis occurred in eight cases.

Conclusions: LSD can occur secondary to a variety of mechanisms; identification and treatment is important since adverse incidents such as emergent CABG and stent thrombosis may occur. A novel classification system is proposed to facilitate future reporting of this complication.