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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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Medtronic received a report regarding one pipeline (lot# b277032) foreshortening, stretched, migration after deployment, movement during placement, and failure to open occurred.For the second pipeline (lot # b347152) migration after deployment occurred.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the right internal carotid artery (ica) with a max diameter of 3.7 mm and a 2.5 mm neck diameter.The landing zone was 3.9 mm distally and 5.1 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level was 3.Angiographic result post procedure showed the first device (lot# b277032) foreshortened distal to proximal (5x14) and the second device (lot #b347152) deployed distal to first and did not fully open on the distal end.The patients past medical history included bilateral ica aneurysms.Left side was treated with fred device and right side treated with pipeline shield.It was reported that first device (5x14) (lot# b277032) was deployed with support from neuron max, phenom plus through phenom 027.Ptfe sleeves were flipped out of the way in a bowl of heparinized saline prior to be inserted in the phenom 027.The device was flushed properly, then inserted into the phenom 027, and advanced up to the m1 section.The tip coil was unsheathed, the distal braid was unsheathed in a curve in the m1 section making it difficult to open, the device was received a few times.After multiple unsheathing in a curved m1, the "system" with a long length of device exposed, was dragged into the ica.The distal device was not fully open.With multiple wagging and resheathing and redeployment, the device was delivered.After going through device with the microcatheter, the distal end of the device opened and foreshortened.This was not appreciated until the phenom plus and phenom 027 were pulled out.Physician made desiring to put a second device distal to first.He selected a 5x12 (lot# b347152).Again, the doctor flipped the ptfe sleeves in saline bowl prior to introducing into phenom 027.The doctor did not use any intermediate catheter.Again, the doctor brought the device through the microcatheter into m1 section, then unsheathed the tip coil and a lot of device.The device (lot# b347152) swelled in the middle section, but the distal end was in a curve and would not open.The physician again made several attempts to get the closed distal end open by resheathing and unsheathing, finally dragging the system into the ica.The distal end of the device opened partially.He continued to deploy the device, using manipulations to get it open.He deployed the device.Pulled the delivery wire out, then went up with a phenom 17 and 14 wire "j".He replaced the phenom 017 with sl-10 and made several passes with j wire.Distal end did not fully open.It was reported failure to open occurred in the distal section.The pipeline was positioned ina proximal, middle, and distal bend.The pipeline had been deployed less than 50% when it failed to open.The pipeline was resheathed more than two times.A wire/catheter was required to open the pipeline.The pipeline was not removed from the patient.Full wall apposition was not achieved.It is unknown if ballooning was required for tapering or to ensure wall apposition.It was also reported there was movement during placement (difficult placement/positioning) that occurred.Two pipeline devices were being used when the movement occurred.The multiple pipeline device implantations were not planned.There was no friction or difficulty during deliveryor positioning.The pipeline was implanted at the intended location.The pipeline did miss the landing zone.Another device was required to remove or secure the pipeline.The device did not jump during deployment.The pipeline was placed at least 3 mm past the aneurysm neck on each side.The ophthalmic side branches were covered by the pipeline.The tip of the catheter was moved during deployment.It was also reported both pipeline devices had migration after deployment occur.The cause of the migration was the first device was stretched during distal deployment.For the second device (lot# b347152) ballooning was not required for tapering or to ensure wall apposition.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were not prepared as indicated in the instructions for use (ifu).The ptfe sleeves were flipped in saline bowl prior to inserting into phenom 027.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a neuron max sheath, phenom plus guide catheter, phenom 27 microcatheter and guidewire.
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