Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the trailblazer not angled support catheter.Survey results received for a vascular surgeon practicing in italy who within the last 12 months used a trailblazer (not angled) catheter in 36 procedures to guide and support a guidewire during access of the vasculature, to allow for wire exchanges, and/or to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.During use of the trailblazer device the following adverse events/complications were reported: intimal disruption (4 occurrences, 1 of which is reported as being related to the device itself), local or systemic infection including sepsis (4 occurrences, none of which are reported as being related to the device itself), perforation and vessel rupture (1 occurrence, which is not reported as being related to the device itself), and surgical intervention (1 occurrence, which is not reported as being related to the device itself).For each of the complications reported, intimal disruption (described as a small intimal laceration treated with medical therapy and watchful waiting) and local or systemic infection including sepsis were reported to be not at all concerning; the perforation and vessel rupture and surgical intervention are reported to have been somewhat concerning.
|