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Medtronic received a report that the distal section of the pipeline failed to open.The patient was undergoing treatment for a saccular aneurysm located in the pcom region of the right internal carotid artery.The aneurysm was previously coiled but recurred.The neck was approximately 6 mm.The landing zone was 3 mm distal 4.1 mm proximal.The vessel tortuosity was normal.Dual antiplatelet treatment had been administered.It was reported that as customer was deploying the pipeline in the mca, it wouldn¿t initially open.The customer then resheathed as per instructions for use (ifu) and it opened more; however, the end appeared damaged on the angio.Stent was removed from patient.Another size of pipeline was deployed to good effect with a good final result.Angiographic results post procedure showed the pipeline fully apposed and in a good position.The pipeline was not positioned in a bend, and more than 50% had been deployed when the pipeline failed to open.The pipeline was resheathed once or twice, and no additional steps were taken to open the pipeline.The patient did not experience any injury or complications.The devices were prepared according to the ifu.Ancillary devices include a phenom microcatheter.
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Product analysis findings: the pipeline flex w/ shield device (model: ped2-425-16 lot: b025220) and the microcatheter were returned for analysis the pipeline flex w/ shield pusher hypotube was found stretched with the ptfe shrink tubing intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The distal delivery wire was broken from the pusher, with the distal segment (dps sleeves and tip coil) not returned for analysis.The broken end was sent out for sem analysis.The phenom-27 total length was measured to be ~157.6cm, the usable length was measured to be ~151.1cm and the distal single coil length was measured to be ~14.6cm; which is within specification.The pipeline flex w/ shield braid was found within the catheter hub.No damages or irregularities were found with the catheter hub.No other damages or anomalies were observed.Based on the device analysis, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the braid was returned fully opened.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.Customer reported device were prepared as per ifu, patient vessel tortuosity as normal, device was not employed in a bend and pipeline was deployed no more than twice.The customer report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.From the damages seen on pipeline flex shield braid (fraying/damage), catheter body (kinking), pusher distal delivery wire (break) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to retract the pipeline flex shield through the catheter against resistance.It is possible patient tortuous anatomy and lack of continuous flush may have contributed to the failure open issues and damages during delivery/retrieval.The sem analysis summary confirmed the wire failed via torsional overload.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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