Medtronic received a report that the distal part of the device wouldn't open despite manipulation attempts.The patient was undergoing treatment of an unruptured, saccular left ica aneurysm with a max diameter of 10mm and a neck diameter of 8mm.The patient's vessel tortuosity was moderate.Dual antiplatelet treatment was given.The devices were prepared as indicated per the ifu.It was confirmed that the middle portion of the device was placed in a bend, less than 50% of the device was deployed when it failed to open, and more than 2 resheathing attempts were made.There were no additional steps taken to attempt to open the device.As a result of the issue the device was replaced.
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Product analysis findings: the pipeline flex shield was returned for evaluation within its inner pouch; inside of a biohazard bag and a shipping box.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 distal end of the pipeline flex shield braid was fully opened and moderately frayed.However, the proximal end of the braid was fully opened and no damage.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 shield was not confirmed to have "failure to open at the distal end" issue.The root cause could not be determined as the distal distal end of the pipeline flex shield braid appeared fully opened and moderately frayed.In addition, the proximal end was fully opened and no damage.The damage to the braid on the distal end of the pipeline flex shield braid is likely the results of the physician re-sheathing the device more than recommended two times.It is possible that the patient tortuous anatomy may have contributed to the failure to open issue.There was no non-conformance to specifications identified that led to the failure to open issue.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex shield embolization device has successfully expanded, deploy the remainder of pipeline flex shield embolization device by pushing the delivery wire and/or unsheathing the pipeline flex shield 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 shield embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex shield embolization device.Re-sheathing the pipeline flex shield 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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