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It was reported that the pipeline was used for an indication that was not approved.The device was to be placed from a1 to contralateral a2.While the physician was placing the pipeline over the aneurysm, it was determined halfway through the deployment that it was too long.When removing the pipeline, there was some tension in the system, and it broke while fully inside the catheter at the proximal bumper.The catheter was flushed continuously with heparazinzed saline.It was noted that the pipeline became stuck in the distal section of the catheter after resheathing during the removal of the device.The physician removed both the pipeline and the catheter.There was no damage to the catheter; however, the pushwire was damaged at the distal section since it broke at the proximal bumper during the removal of the undeployed pipeline.There were no patient complications associated with this event.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was good.The patient was being treated for a saccular, acom aneurysm that was previously coiled with residual neck filling.The distal landing zone was 2mm, and the proximal landing zone was 2.6mm.It was noted the vessel tortuosity was minimal.
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It was "reported" that the medtronic flow diverter broke at the proximal bumper while fully inside the catheter as it was being removed during the use of indication in which it is not approved.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to investigate the event and/or determine the cause of the event.The health care provider and the manufacturer representative were contacted to obtain additional event details.The device was returned as part of this investigation.Analysis found this event was similar to an event that had already been investigated, and another investigation is not necessary.(medtronic flow diverter-catheter interaction).Based on that investigation, resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.Although there was minimal resistance removing the medtronic flow diverter flex delivery system from within the medtronic microcatheter, the medtronic microcatheter was found damaged (accordioned).Damage to the catheter is likely to occur if excessive force is used.However, the cause for the resistance could not be determined.Regarding the customer¿s report of ¿pushwire break/separation,¿ the issue could not be confirmed as no breaks or separations were found with the returned medtronic flow diverter flex delivery system.The medtronic flow diverter flex pusher was found bent; however, the cause for the damage could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿resistance during re-sheathing¿ was confirmed.The medtronic flow diverter flex embolization device was returned within the medtronic catheter.The medtronic flow diverter flex pusher was found protruding from within the microcatheter hub.The medtronic flow diverter flex pusher was found kinked within the microcatheter at approximately 110.0cm from the proximal end of pusher.The microcatheter body was found accordioned near the distal tip.No damages were found with the microcatheter distal marker/tip.The medtronic flow diverter flex embolization device was pulled out from within the microcatheter with slight resistance.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No damages were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker or with the tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No bend was found on the pushwire.The microcatheter was flushed, water exited from the distal tip.An in-house mandrel was inserted into the microcatheter hub and pushed through the distal tip lumen with slight resistance at the damaged (accordioned) location.The braid was not returned.The reason for the braid not returning was not provided.No other anomalies were observed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.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.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.
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