The pipeline flex was returned.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The pipeline flex braid appeared fully opened and no damage.No bend found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing marker or with the proximal bumper.No damage found with the returned catheter.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open as pipeline flex braid was found fully opened and no damage.Mdrs related to this event: 2029214-2019-01173, 2029214-2019-01174, 2029214-2019-01175.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received a report of pipeline flex incomplete opening during a procedure.The patient was undergoing treatment of a left ica, unruptured, saccular aneurysm.The distal landing zone was 3.7mm and the proximal was 4.1mm.The vessel tortuosity was minimal.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed per the ifu.It was reported that during the procedure, a pipeline flex was attempted to be placed and did not open in the middle and proximal sections.The device was resheathed with the microcatheter and removed.There were no reports of injury in association with this event.
|