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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Medtronic received a report that two pipeline stent's failed to open.The patient was undergoing neurointerventional minimally invasive procedure with blood flow-diverting stent implantation for treatment of an amorphous, unruptured left internal carotid artery ophthalmic artery segment aneurysm.It had a max diameter of 4.1 mm and a 3.7 mm neck diameter.The landing zone was 3.3 mm distally and 4.3 mm proximally.The access vessel was the femoral artery with a diameter of 6.5 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered within a normal platelet reactivity units (pru) range.The angiographic result post procedure was normal.It was reported that the access was established smoothly, and the phenom 27 stent catheter was successfully advanced to the m1 segment of the middle cerebral artery.The ped2-450-18 was fully hydrated with high-pressure saline and delivered intracranially without difficulty.However, after approximately 10 mm of the stent was exposed, the tip end still failed to open and appeared morphologically abnormal.Under digital subtraction angiography (dsa) fluoroscopy, the braided wires at the tip end of the stent appeared to have become separated from each other, which was abnormal.The operator attempted to retrieve and redeploy, but the stent could not return to a normal configuration.Considering the risk of damage to the tip end of the stent, the entire system was removed.The operator then firmly chose a ped2 stent again, this time a ped2-450-20, and repeated above steps.On this attempt, the tip end opened smoothly; however, when the stent reached the mid-segment¿at the bend of the carotid siphon¿it failed to open when viewed from multiple angles, showing a typical kinking configuration.The operator deployed a greater length of the stent and attempted maneuvers such as overall oscillation, retrieve, and redeployment.However, the stent still could not be opened at this curved segment, and there remained a considerable distance to the proximal end of the stent.Ultimately, the operator did not dare to deploy the stent; the entire system was recovered and removed out of the patient.A flow-diverting stent from stryker was then used instead, and the procedure was completed successfully.The ped2-450-18 failed to open in the distal section.It was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.It was resheathed less than or equal to 2 times.There were additional steps or other devices required to open the pipeline which were to deploy a greater length and retrieve, redeploy.The pipeline was resheathed and removed with the microcatheter, and from the patient.The ped2-450-20 had failure to open in the middle section.It was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.It was resheathed less than or equal to 2 times.There were additional steps or other devices required to open the pipeline which were to deploy a greater length and retrieve, redeploy.The pipeline was resheathed and removed with the microcatheter, and from the patient.There were no patient symptoms or complications associated with this event.The pipeline was not used for an indication that is not approved (off-label).The p ipeline and accessory devices were prepared as indicated in the instructions for use (ifu).The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.Ancillary devices include a 6f neuron max 90cm long sheath, ton-bridge medical silver snake6f 115cm intermediate guide catheter, phenom 27 microcatheter, sychro 0.014 inch 200cm guidewire.
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B5: additional information added to event summary.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Additional information was received.For the ped2-450-18, it was reported that the causes and contributing factors for the failure to open and braid damage were not identified.The braided wires of the ped2-450-18 stent tip end were interwoven with each other.If they become misaligned, this is what we call ¿separated¿.From fluoroscopy, it appeared that this might have been the case.The ped2-450-18 stent was fully retrieved after deployment and then redeployed, but it still was not a normal configuration.For the ped2-450-20, it was reported that the causes and contributing factors for the failure to open and kink were not identified.It is uncertain if there is any device issue with the phenom 27 microcatheter.
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