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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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Sebahat nacar dogan, feyyaz baltacioglu, ikram eda duman, baris kucukyuruk, sebnem batur, buge oz, osman kizilkilic, civan islak, naci kocer.Cerebral abscess following endovascular treatment of aneurysm: report of 2 cases and review of the literature.Doi: 10.101 6/j.Wneu.2019.02.220.Medtronic literature review found a report of a patient complication after axium coil implantation.The purpose of the article was to discuss the possible mechanisms underlying cerebral abscess after endovascular treatment of aneurysms and to suggest potential treatment and prevention methods.An (b)(6) man with a history of chronic hypertension and prior subarachnoid hemorrhage presented with symptoms of headache and vertigo.He had no gross neurologic deficit.Imaging revealed a wide-necked partially thrombosed intracranial aneurysm of the anterior communicating artery filling from the left internal carotid artery.Its dimensions were 36x38x25 mm, and a large daughter sac originated from the inferior aneurysm wall.A smaller (4x3x3 mm) wide-necked aneurysm of the left middle cerebral artery (mca) bifurcation was also observed.Endovascular treatment was selected rather than open surgery because of the patient¿s age and comorbidities.The anterior communicating artery aneurysm was embolized with 12 detachable coils (axium coils: medtronic, irvine, usa; microplex coils: microvention, tustin, ca, usa) in a single session of 75 minutes.Minor residual filling occurred at the aneurysm neck.No ant ibiotic prophylaxis was used during the procedure.Cranial computed tomography obtained 10 days postoperatively revealed no new findings; the thrombosed portion of the coiled aneurysm was present as a hyperdense region at the right side of the aneurysm.Control angiography at 30 days postoperatively revealed recurrent filling restricted to the coils on the inferior wall in the daughter sac; the primary lobule was stable.The patient¿s laboratory findings were normal, and he did not show any new neurologic deficits.Two months later, the patient presented with dysphasia, dizziness, and headache.He had fever and leukocytosis (12,000/mm3) with increased levels of creactive protein level (28 mg/l).Blood cultures, both aerobic and anaerobic, were negative.The result of urinalysis was consistent with moderate urinary tract infection.Brain magnetic resonance imaging (mri) revealed newly developed left frontal vasogenic edema.Control angiography revealed increased recurrent filling of the daughter sac, in addition to severe stenosis of the a2 segment of the right anterior cerebral artery.Brain mri revealed t2 hyperintense lobulated lesions with ring enhancement at the left basal frontal lobe and left basal ganglia.Diffusion-weighted imaging revealed restricted diffusion in the left basal ganglia.Empiric therapy was initiated with wide-spectrum antibiotics.Control imaging after 2 weeks of antibiotic therapy revealed progression of the lesions, with emphasized ring enhancement.The patient did not recover clinically and required surgical sampling.Cerebrospinal fluid and cerebral tissue cultures were negative, likely because of antibiotic suppression; however, histopathologic diagnosis was consistent with cerebritis and abscess.The patient fully recovered by 2 weeks postoperatively, and mri revealed complete regression of lesion enhancement.The patient was discharged on oral antibiotics.(b)(6) right-handed woman presented with headache, and cranial mri revealed a giant aneurysm at the level of the mca bifurcation.Subsequently, angiography confirmed the presence of a giant (28x20x23 mm) aneurysm of the mca bifurcation with a wide neck that included the origins of both the inferior and the superior trunks.The patient declined suggested treatments of surgery or intracranial-extracranial bypass.One year later, the patient again experienced progressive severe headache.Angiography revealed transformation of the aneurysm into a partially thrombosed, serpentine aneurysm; it had also increased in size (32x23x27 mm).Inferior and superior branches originated from the distal portion of the aneurysm.A balloon occlusion test in the distal portion of the m1 segment of the mca revealed that the mca superior branch and a portion of the inferior branch were reconstructed from pial collateralization from the anterior cerebral artery, with limited delay.Parent artery occlusion and total embolization of the aneurysm were achieved with the use of 30 detachable coils (axium coils; medtronic, irvine, usa).The duration of the procedure was approximately 120 min utes.No prophylactic antibiotic therapy was used, according to standard treatment protocol.The patient experienced minor dysphasia, and mri demonstrated acute ischemia in the left temporal lobe at the inferior trunk of the mca.After the patient began anticoagulation therapy, her dysphasia symptoms were fully resolved, and she was discharged from the hospital 1 week later.One month later, the patient presented with dysphasia, confusion, headache, and facial palsy.Repeated cranial mri revealed a lesion suggestive of cerebral abscess with ring enhancement, diffusion restriction, and peripheral vasogenic edema; the maximum size of the abscess on the anterior superior contiguity of the treated aneurysm was 3 cm.Her peripheral white blood cell count was normal (8.5.103/mm3), but her c-reactive protein was high (32.4 mg/l).Control angiography confirmed total occlusion of the aneurysm.Wide-spectrum empiric antibiotic therapy was initiated.However, the size of the abscess and the patient¿s symptoms did not diminish; therefore, surgical drainage of the abscess was performed after 1 week of medical treatment.Cultures revealed no colonization of surgical samples.After drainage, the patient¿s symptoms subsided, and she was discharged receiving wide-spectrum empiric antibiotic therapy.Three months later, mri was performed because of the development of right hemiparesis; a new abscess formation was detected near the coiled aneurysm sac, and surgical treatment was required.Both the abscess cavities and the coiled aneurysm sac were resected.Subsequently, a neighboring abscess was drained.Propionibacterium spp.And methicillinresistant staphylococcus isolates were present in the culture of the abscess tissue.Meropenem antibiotic therapy was prescribed.Two weeks later, the patient was discharged because her symptoms had resolved.On mri performed 2 months after discharge, no abscess was present.
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