Medtronic received information regarding a pipeline flex which failed to open in the middle section.The patient was being treated for an unruptured amorphous aneurysm of the horizontal potion of the cavernous segment.The aneurysm max diameter was 7.24mm and the neck diameter was 3.35mm.Vessel tortuosity was moderate.It was reported that after the microcatheter was in place at the aneurysm location the pipeline flex stent was delivered.The microc atheter was retrieved to deploy the pipeline.More than 50% of the pipeline was deployed, over 15mm, but both the middle and distal sections failed to open even after waiting for more than 10 minutes.The pipeline was retrieved into the microcatheter and then deployed again, again more than 15mm, but still there was no sign of opening after waiting for more than 10 minutes.A third attempt was also made to retrieve and redeploy without success.The pipeline was not placed in a vessel bend.The pipeline was retrieved from the patient with a snare retrieval device and replaced to complete the procedure.The devices were prepared and used per the instructions for use (ifu).There was no harm or injury to the patient.Ancillary devices: marksman microcatheter.
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H3: the pipeline flex pushwire was returned for evaluation.There was no pipeline flex braid returned with the pushwire.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.No bend found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have "failure to open" issue.The root cause could not be determined as pushwire was returned without the pipeline flex braid.No damage was found with the pushwire.Possible causes of failure to open include patient vessel tortuosity and damage to the braid.There was no non-conformance to specifications identified that led to the failure to open issue.Since the pipeline flex braid was not returned; any contribution of the braid to the reported issue could not be determined.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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.
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