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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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In-suk bae, hyeong-joong yi, yong ko, young soo kim, hyoung-joon chun, kyusun choi; world neurosurgery; 2019; 127:e76-e85; practical incidence of complications and degree of patient satisfaction after endovascular coil embolization for unruptured intracranial saccular aneurysm based on patients¿ surveys; doi.Org/10.1016/j.Wneu.2019.02.093.Medtronic received information that patients potentially treated with axium coils had complications.112 patients treated for saccular unruptured intracranial aneurysms (uias) were evaluated.One single-center experience of endovascular treatment of patients with saccular uias was presented.From august 2008 to september 2012, a total of 135 uias were occluded with detachable coils and/or stent, balloon at the hospital.Patients with dissecting or fusiform aneurysms, aneurysms treated with parent artery sacrifice, aneurysms associated with brain arteriovenous malformations or tumors, and mycotic aneurysms were excluded from the study.Patients with uia who also had a ruptured aneurysm or multiple aneurysms were excluded to avoid selection bias.Of the 135 patients treated for uias, 23 patients were excluded based on the inclusion criteria.Eighty-seven of 98 aneurysms were located in the anterior circulation, and 11 were in the posterior circulation.Frequent locations included the paraclinoid internal carotid artery, middle cerebral artery (mca), anterior communicating artery, and posterior communicating artery.The size of aneurysms ranged from 3.0e28 mm in maximum diameter, with a median size of 6.2 mm (mean 7.0 mm).Aneurysm necks ranged from 2.0 to 22 mm, with a median size of 4.2 mm (mean 4.8 mm).The dome-to-neck ratio (aspect ratio) ranged from 0.67 to 2, with a mean of 1.15.All aneurysms were coiled with patients under general anesthesia.Systemic heparinization was performed after placement of the arterial introducer sheath according to our embolization protocol; 3000 iu of heparin was administered as an intravenous bolus injection, followed by an additional 1000 iu per hour.Heparin was discontinued after embolization in most patients but not reversed.Each aneurysm embolization was performed using detachable coils.Aneurysms were occluded with guglielmi detachable coils, axium coils, deltapaq coils, or target coils.Hemostasis was achieved using the angio-seal vascular closure device after removing the femoral sheath catheter in all cases by applying a sandbag for 6 hours.Neck remodeling techniques (stent-assisted or balloon-assisted) were used when necessary for aneurysms with unfavorable angioarchitecture instead of the simple technique.Either the enterprise stent or a neuroform stent was placed within the afferent to efferent vessel¿s lumen before coiling.In all cases, aneurysmal sac and neck were packed until no contrast filling of the aneurysm sac was confirmed based on angiography.The antiplatelet preparation prescribed was aspirin 100 mg/day and clopidogrel 75 mg/day orally for at least 5 days before coiling.If these daily regimens were not followed, aspirin 400 mg and clopidogrel 800 mg were given in loading doses.Complications: intracranial complications (stroke) occurred in 10 aneurysms; 7 ischemic (thromboembolic) and 3 hemorrhagic (intraprocedural rupture).Thromboembolic complications occurred in 7 patients; 1 resulted in a persistent neurologic deficit, which was in accordance with the consequences of a left cerebral infarct secondary to mca branch occlusion, 2 resulted in transient neurologic deficits that resolved within 24 hours postoperatively, and 4 were asymptomatic.In patients who showed partial filling defect in branch during or at completion of procedure, intraarterial rescue with tirofiban was performed, and an intravenous anticoagulation with heparin was sustained for 24 hours after intra-arterial trial.In 3 patients with rupture, 1 occurred during micro-guidewire navigation with resultant diffuse subarachnoid hemorrhage and focal parenchymal hematoma, which was managed by swift coil packing and stent deployment.The patient died from direct effect of hemorrhage.In the other 2 patients, rupture occurred during the second and final coil packing and they were conservatively managed uneventfully.In the 10 cases with complications, aneurysm locations included the mca in 3 patients, anterior communicating artery in 2 patients, internal carotid artery in 2 patients, posterior communicating artery in 2 patients, and the basilar tip in 1 patient.Other complications included alopecia, bleeding tendency, and puncture-site hematoma.Overall, 30 of 98 patients reported complications after treatment.In 17 patients, alopecia had occurred mainly in the most dependent portion (i.E., occipital) immediately after the procedure in 6 patients, and 2-4 weeks after the procedure in 11 patients.In all patients, no specific additional treatment for these complications was necessary and hair growth was observed after 6 months.Fifteen patients had multiple bruising on extremities or gingival bleeding; however, additional treatment for these symptoms was not required.Most symptoms related to antiplatelet medication were halted after drug discontinuation.One patient suffered acute interhemispheric subdural hematoma in a vehicle collision, and medication had to be stopped with no consequence.Medication was tempora rily stopped in 2 patients due to tooth extraction and endoscopic resection for gastric cancer.Each patient resumed prescription thereafter without any incidents.Puncture-site complication occurred in 3 patients after treatment.One elderly female patient suffered retroperitoneal hematoma that progressed to renal failure and shock.Another 2 patients reported groin swelling up to 1 month postoperatively, which subsided spontaneously.For each complication, the complication rate was not significantly different based on the relevant endovascular techniques.Five of the 98 aneurysms showed recurrence.Of these lesions, 3 with small neck recurrences were not candidates for a second treatment because the recurrences appeared too small for further coil placement; 2 were posterior communicating arteries and 1 was the ophthalmic artery.Two aneurysms constituting basilar tip and anterior communicating artery required repeat coil packing at 1 year and 3 years after first coiling.In summary one patient died from intraoperative rupture; a direct complication after endovascular treatment.In addition, 2 patients died due to indirect complications.One patient died from an acute myocardial infarction, and another patient died from aspiration pneumonia.
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