MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED3-027-450-40 |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
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Patient Problems
Stenosis (2263); Obstruction/Occlusion (2422)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information reporting that at the 6 month follow-up appointment after a pipeline stent (model: ped3-027-450-40, lot: a942457) was implanted, dsa noted "endoleak and stretchingof the left ica pipeline¿.The patient was asymptomatic and no additional medical interventions were performed.The patient had been treated with flow diversion for an unruptured saccular aneurysm of the c5.The aneurysm max diameter was 5.3mm and the neck diameter was 1.3mm.Vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered with pru level of 94.Post-operative angiography revealed raymond and royal class 3 - residual aneurysm with complete aneurysm neck coverage of a minimum of 3mm at each side of the aneurysm neck.Additional information received reported that 180 day follow-up imaging to the core lab did not note ¿endoleak or stretching,¿ however they did note the in-stent stenosis, device flattening, and incomplete wall apposition.The target intracranial unruptured saccular aneurysm was located at the left internal carotid artery segment (c5) measuring 5.3x4.0mm with dome-to-neck ratio 1.3.
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Event Description
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Additional information received indicated the core lab finding noted total occlusion of the left anterior cerebral artery (aca) which was jailed by the pipeline device.There was good cross filling from the anterior communicating (acom) artery.There was no neurological impact, and the sponsor reviewed imaging and confirmed the left aca occlusion as of (b)(6) 2021.
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Manufacturer Narrative
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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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Manufacturer Narrative
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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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Event Description
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Additional information received reported that triaging conservatively as site has reported a decline in the 2nd year imaging follow up visit with respect to 1st year.At the 1st year imaging follow visit, per dsa the raymond-roy occlusion scale of target aneurysm was class 1: complete occlusion with no stenosis in parent artery - now, in the 2 year imaging follow up visit, per mra the raymond-roy occlusion scale of target aneurysm declined to class 3: residual aneurysm with > 25%-50% stenosis in parent artery.
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