Medtronic conducted a post market clinical follow-up (pmcf) survey to collect postmarket information on the safety and performance of the medtronic family of aspiration catheters (export advance and export ap).Interventional cardiologists who use the devices participated in the survey to help confirm use of the devices and to ensure medtronic is aware of all potential complications associated with the use of export advance and export ap devices.It was reported that during use of the export advance emboli occurred in three cases, one related to a pre-existing condition or comorbidity, one related to the procedure but not directly to the device and one directly related to the device.Arterial perforation was reported to have occurred on four occasions, two related to a pre-existing condition or comorbidity, one related to the procedure but not directly to the device and one directly related to the device.Hypotension was also reported to have occurred on four occasions, two related to a pre-existing condition or comorbidity, one related to the procedure but not directly to the device and one directly related to the device.It was also reported that during use of the export advance device that it was not as expected and failed to maneuver easily.
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