|
Gobin, dunkel, marr, brodie, and abramson; american medical association; 2011; 129 (6), pp.732-7; intra-arterial chemotherapy for the management of retinoblastoma: four-year experience.; 10.1001/archophthalmol.2011.5 medtronic received information in a literature article that patient's treated with marathon microcatheters to deliver intra-arterial (ia) chemotherapy for the management of retinoblastoma had complications. from may 30, 2006, to may 30, 2010, we treated 78 patients with unilateral or bilateral intraocular retinoblastoma (95 eyes treated) with ia chemotherapy.43 female, 35 male.In most cases, a straight microcatheter, such as the marathon microcatheter (ev3, irvine, california) or the magic 1.5 microcatheter (balt, montmorency, france), was placed at the ostium of the ophthalmic artery.Once the microcatheter was in place, selective angiography of the ophthalmic artery was performed to visualize the angio-anatomy.Whenever the ophthalmic artery was not appropriate for selective catheterization (because it was too small or was making an acute angle off the internal carotid), 2 other techniques were used.The first alternative technique used the ipsilateral middle meningeal artery anastomosis to the orbit.Catheterized the middle meningeal artery and performed selective angiography to determine whether the orbital branch was well developed.If it was, then selective catheterization of this orbital branch permitted the injection of chemotherapy selectively into the orbital vasculature.If it was not well developed, then we either discontinued the procedure or elected to use the ¿japanese technique,¿ which consists of placement of a temporary balloon to occlude the internal carotid artery above the origin of the ophthalmic artery and infusion into the internal carotid artery below the balloon. after drug delivery, the catheter was removed and hemostasis of the femoral artery was obtained with manual compression.After awakening, the child was kept in the post-anesthesia recovery unit for 5 hours before being discharged home.Catheterizations were successful in 255 of 259 procedures (98.5%).The 255 successful procedures resulted in 221 unilateral and 34 bilateral ia catheterizations for a total of 289 ia injections of chemotherapy.The number of procedures ranged from 1 to 7. four procedures were unsuccessful: 3 unilateral and 1 bilateral failed attempt at catheterization.Catheterization failures occurred when they could not selectively catheterize the ophthalmic artery, when there was no access to the orbital vasculature through the middle meningeal artery, or when they did not want to use the japanese catheterization technique because of a tortuous internal carotid artery or the very young age of the patient. there was no significant groin hematoma; 1 transient occlusion of the superficial femoral artery recanalized with aspirin after 1 week.There were 24 occurrences of significant bronchospasm during the procedure; in each instance, significant bronchospasm occurred during the second or later procedure, and when the microcatheter reached the cavernous carotid or ophthalmic arteries.Untreated bronchospasm could become severe, and then we would also observe bradycardia and hypotension.Thus, tidal volume and inspiratory pressure were carefully monitored: if bronchospasm appeared, catheterization maneuvers were discontinued and epinephrine bitartrate was injected intravenously.After cessation of bronchospasm, catheterization could be resumed. there were no neurological complications. ten eyes developed a temporary inflammatory syndrome with periocular edema and redness.An avascular retinopathy with total visual loss was observed in 4 eyes.Standard treatment in the institution would have been enucleation: 3 of them had already been unsuccessfully treated. 1 was preceded by an inflammatory reaction. three eyes developed a cataract; of these, 2 received recent radiation therapy.Transient red discoloration of the skin in the mesial frontal area (in the cutaneous territory of the ophthalmic artery) was s een in 14 cases after injection of melphalan.10 twelve cases had temporary thinning or loss of eyelashes along the medial third of the upper eyelid.
|
|
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.
|
