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Medtronic received information regarding a pipeline stent that failed to open completely.The patient was being treated for an unruptured amorphous aneurysm of the left interior carotid artery (ica).The aneurysm reported max diameter was 2.01mm and the neck diameter of 7.92mm.Vessel tortuosity was severe.It was reported that the microcatheter was placed in the proximal segment of the middle cerebral artery (mca) to open the pipeline stent distal to the landing zone.The stent was delivered through the catheter and the distal end of the stent was pushed out by the pushwire but it was not opening.Several attempts were made to pushed the pushwire and pull the microcatheter but the stent still did not open.The pipeline stent was fully resheathed and delivery reattempted but it still did not open successfully.The system was repositioned at a more proximal location, at the ica distal to the landing zone, for distal opening.The same steps were completed without success.The stent was again fully resheathed and redelivered.The distal end of the stent the stent opened slightly but was in a funnel shape, part of the mid-section also opened but the proximal end did not.All devices used in the procedure were prepared and used as indicated in the instructions for use.The proximal end of the device was positioned in a bend in the patient's anatomy.The device was resheated more than two times and continuously did not open completely.The pipeline was resheathed and removed from the patient.Another device was then used to successfully complete the procedure.There was no harm or injury to the patient.Post-procedure angriography showed satisfactory results with no deficit.
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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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No damages or irregularities were found with the proximal pipeline flex w/ shield pusher.The pusher hypotube was found broken at the distal hypotube with the ptfe shrink tubing undamaged at that same location.No stretching was found with the hypotube.The distal broken segment was not returned for analysis.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: ¿some of the fracture surfaces exhibit corrosion damage.Dimple features consistent with ductile overload failure mechanism are visible¿.The catheter total length was measured to be ~158.7cm, the usable length was measured to be ~152.2cm and the distal single coil length was measured to be 14.3cm, which is within specification = 156.5cm, usable length = 150cm ± 5cm; distal single coil length = 15cm ±2cm).No flash or voids molded were observed in the phenom-027 hub.No damages or irregularities were found with the catheter hub, distal tip or marker band.The catheter body was found kinked at ~4.1cm from the distal end.The inner diameter of the phenom-027 was measured via pin gauge to be 0.0270¿ (proximal) and 0.0265¿ (distal) which is within specification : 0.027¿ ± 0.001¿ and compatible for use with the pipeline flex w/ shield device.The micro catheter was flushed, and water exited the distal end.An in-house 0.026¿ mandrel was inserted into the hub and the pipeline flex w/ shield braid was pushed out.The mandrel was then used for resistance testing.The mandrel was inserted through the catheter hub, through the catheter body and exited the catheter tip with no issues and no resistance encountered.The distal braid and middle braid sections fully opened.The distal braid was found slightly frayed and damaged.The proximal braid segment did not open and found to be damaged/frayed.Blood was found on the proximal braid.The blood was dissolved; however, the braid still did not open.No other anomalies were found.Based on the analysis findings, the customer report of ¿failure/incomplete to open¿ was conf irmed as the proximal section of the braid failed to open when advanced out of the micro catheter; however, the cause cannot be determined.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overs tretched during delivery, user deploys braid in a vessel bend, presence of other indwelling endovascular stents or inappropriate anatomy.Customer reported the device was prepared per ifu, the distal end of the braid was in a funnel shape, the device was re-sheathed more than two times and there was no resistance during procedure.It is likely the proximal braid became damaged during analysis when attempting to push the braid out of the catheter using a mandrel, however, it is also possible that the braid was damaged during procedure causing the braid to not open.The sem results show that ductile overload was the cause of the break found on the distal hypotu be, indicative that the pipeline flex w/ shield delivery system was retracted against resistance.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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