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Event related to regulatory reports #: 2029214-2023-00321, 2029214-2023-00322, and 2029214-2023-00323.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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Fan, fu, liu, yang, zhang, li, shi, wan, zhao, wang, feng, song, wang, mao, maimaitili, and guan; frontiers in aging neuroscience; 2022; (14): 905224; multiple pipeline embolization devices for the treatment of complex intracranial aneurysm: a multi-center study; doi: 10.3389/fnagi.2022.905224.Medtronic received information in a literature article that patients treated with pipeline (ped) devices had complications. the purpose of this study was to investigate the indications and strategies of using multi-peds for complex intracranial aneurysms. patients who had been treated with two or more peds were included in the post-market multicenter registry study from 2014 to 2019, across 14 centers in china. the inclusion criteria were as follows: (1) intracranial aneurysms treated with two or more peds or (2) salvage for failed ped treatment.Exclusion criteria comprised of (1) two or more peds used to treat aneurysms in different arteries and (2) subarachnoid hemorrhage (sah). among the 55 patients, 31 were men and 24 were women.Their ages ranged from 8 to 76 years.The average was 46.7 years.Among them, 49 patients presented with headache, visual disturbance, ischemia-related symptoms, or other symptoms, and six cases presented with accidental findings. a total of thirty-nine aneurysms were located in the internal carotid arteries, 13 in the vertebrobasilar arteries, two in the middle cerebral arteries, and one in the posterior cerebral artery.The maximum diameter was 4.1¿51.1 mm, and the morphological aneurysm classifications included 30 sacs, 21 fusiform, and four irregular sacs.Procedure: patients were treated with aspirin (100 mg daily) and clopidogrel (75 mg daily) for 5¿7 days before the operation.All patients were treated under general anesthesia via a transfemoral arterial approach. a 7-f sheath was used to guide the multifunctional 5-f catheter and 0.035-inch super-slippery microguidewire to the initial segment of the internal carotid artery or the first segment of the vertebral artery.Under the working position, a navien 5-f distal support catheter. was inserted near the aneurysm neck.Assisted by the microcatheter, the microguidewire, and the 5-f distal support catheter, the stent markman catheter was passed through the aneurysm neck and was placed at the distal segment of the parent artery.If the coil was indispensable, the embolization microcatheter was positioned through the 7-f guiding sheath, in parallel to the 5-f distal support catheter, and the head part of the microcatheter was introduced into the sac with the assistance of a 0.014-inch microguidewire.Subsequently, a multi-ped system was implanted.These strategies included telescope and overlap techniques.Angiography was preformed and if necessary, post-operative adjustment could be applied to correct poor opening or wall attachment. results: multiple pipeline embolization devices were successfully implanted in 55 patients. the peds were successfully opened in 53 patients and required adjustment in two patients. during the perioperative period, eight patients developed neurological dysfunction. a total of three patients died, one patient developed sah and received conservative treatment, one patient developed post-operative hypoperfusion, one patient developed thrombogenesis during the operation, and two patients developed transient ischemic attacks. among the three died patients, two were with brainstem compression and ischemic stroke of posterior circulation and one suffered with sah of anterior circulation in the early post-operative period. angiography revealed complete occlusion in 26 patients, near occlusion in five patients, and the lack of occlusion in three patients.During follow-up, one patient had internal carotid artery occlusion on the operation side (mrs 0), one patient had asymptomatic occlusion of the ophthalmic artery on the operation side (mrs 0), and one patient had transitory blindness (mrs 0).The remaining patients had no stenosis of the parent arteries and no new neurological complications.
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