Medtronic received a report that resistance in the middle and distal part of the catheter occurred.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ica (internal carotid artery) with a max diameter of 7mm and a 6mm neck diameter.The patient's blood flow was unknown and vessel tortuosity was severe.It was reported that the microcatheter was ascended according to the conventional technique to the distal m1 segment, with difficulty given that the patient anatomy was complex.At the moment that the pipeline was raised inside, friction was noticed in the middle and distal segment, mainly associated with the area with the most curvature of the carrier vessel.Even so, more than the distal tip of the microcatheter never came out and at that moment it was noticed that the thrust guide separated from the diverter and wrinkled.It was noted the diverter opened inside the microcatheter.At that moment, the entire system was removed and attempted to be retried with a second marksman microcatheter and with a new pipeline of the same size and diameter, however, the same event described above occurred, so the system was removed again.After 5 hours of the procedure, the case was terminated and rescheduled.The catheter was flushed continuously with a heparinized saline.It was indicated that the pipeline did become stuck in the distal section of t he catheter during delivery.The physician did release the load (slack) in the system in an attempt to resolve the issue.This did not resolve the issue.The catheter and pushwire were not damaged.It was also indicated the device opened prematurely during deployment, which resulted in moderate friction or difficulty during the procedure.The pushwire was rotated or pulled back during the procedure.This issue occurred with two devices of the same size and diameter.The excess friction was understood by the anatomy but it was striking that in the same deployment area they got stuck, which generated premature opening in the microcatheter.A dapt (dual antiplatelet treatment) was administered.The pru level was prasugrel.The angiographic result post procedure showed patient aneurysm.The pipeline and accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or complications were associated with the event.There was no medical or surgical intervention needed to prevent a permanent impairment of a friction.The event did not lead to or extend patient hospitalization.Ancillary devices include a shuttle guide catheter sheath, navien microcatheter, marksman 27 guidewire, and avigo 014.
|
H3: the distal and proximal ends of the pipeline flex shield braid were fully opened with no damages.No other anomalies were observed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|