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Medtronic received a report that the pipeline device failed to open at the distal end, and a second stent had required balloon angioplasty due to insufficient apposition.It was reported that the catheter was navigated to the middle cerebral artery and the stent was pushed.Due to the small diameter of the m1, the physician did not observe the stent open distally.The physician then resheathed the device to push the ptfe sleeves forwards.After pushing out the stent a second time, he dragged the entire system into the internal carotid artery (ica).They then proceeded to deploy 50% of the device in the ica.The device did not open as expected; the distal 25% of the device appeared pinched while the remainder of the device appeared to be partially opened.To try and help the stent open they resheathed and deployed the stent 3 more times using standard push technique.The physician did have to unsheathe to release tension in the system.The distal part of the device appeared abnormal at this point and a decision was made the retrieve the device with the microcatheter.Deployment of a second device was exactly the same except they did not attempt to push the ptfe sleeves in the m1.The device was deployed successfully, but distal apposition was insufficient.Balloon angioplasty was performed successfully.The patient did not experience any injury or complications.After the procedure, angiographic results showed all branches were fully patent, and the aneurysm did not show much stasis.Dual antiplatelet treatment had been administered.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for a saccular aneurysm located in the posterior communicating artery.This aneurysm recurred after rupturing 5 years ago, at which time it was coiled.The max diameter was 5 mm.The neck diameter was 4.5 mm.The landing zone was 4.9 mm distal, and 3.7 mm proximal.The patient¿s vessel tortuosity was moderate.Ancillary devices include a phenom 27 microcatheter and navien support catheter.
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No damages or irregularities were found with the proximal pipeline flex w/ shield pusher.When compared to the drawing the distal and proximal dps restraints were found to be intact.The dps sleeves were found damaged.The hypotube was intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found intact.The phenom-027 micro catheter total length was measured to be ~157.9cm, the usable length was measured to be ~151.3cm and the distal single coil length was measured to be ~14.5cm, which is within specification (specification: total (reference)= 156.5cm, usable = 150cm ± 5cm, distal single coil = 14cm ± 2cm).No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.The pipeline flex w/ shield braid was found within the hub and proximal end of the micro catheter.The phenom-027 micro catheter body was found kinked at ~4.2cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The micro catheter was flushed with water and water exited out from the catheter tip.A 0.0260¿ mandrel was used to push out the pipeline flex w/ shield against high resistance.The catheter was then tested by running an in-house 0.0260¿ mandrel back through microcatheter.The mandrel passed through the catheter hub, catheter body and distal tip with no resistance encountered.Once deployed out of the micro catheter, the distal and proximal ends of the pipeline flex shield braid were found fully opened, with both ends damaged/frayed.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the device fully opened when deployed out of the micro catheter and no images or videos were submitted by the customer for review.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.Customer reported that the distal end did not open due to the small diameter of the m1.The device was also re-sheathed more than two times which could contribute towards braid damage and potentially contribute towards the failure to open.The dps sleeves were found damaged.It is possible that the damage occurred during the multiple repositioning attempts or due to the damages found on the braid.As the braid was found stuck within the catheter, and a mandrel was used to remove the braid, at least some of the damages found on the braid was caused during the attempt to retrieve the braid during analysis.The catheter was found kinked.Possible causes are patient vessel tortuosity, guidewire or delivery system removed aggressively, catheter entrapment or user advances or retract the device against resistance.There is no indication that the event is related to a potential manufacturing issue.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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