MINNEAPOLIS, MN — Medtronic has issued a field safety notice for physicians and healthcare professionals calling for caution in using the EnVeo R catheter system during transcatheter aortic-valve replacement (TAVR) after the company received reports of vascular trauma.
Although the reports have been infrequent, they number 39 events (0.136% of patients), including 19 patient deaths (0.078%), according to Medtronic.
Medtronic's letter includes several suggestions for physicians to consider, including patients' complex anatomical configurations that may exhibit such features as tight curvature of the aortic arch.
The company advises that if the delivery system tip bends in a different direction relative to the delivery system capsule, physicians should not force passage but retract the delivery system.
Medtronic also says that "if significant resistance is encountered during advancement of the delivery system, do not force passage" and advises the use of increased fluoroscopic magnification to assess the vasculature.
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Cite this: Medtronic Safety Notice on EnVeo R Catheter, Suggests Procedures to Take During TAVR - Medscape - Aug 19, 2016.