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Model Number UNK-NV-ECHELON |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 01/01/2008 |
Event Type
Injury
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Event Description
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Li j, zeng g, zhi x, bian l, yang f, du j, ling f, zhang h.Pediatric perimedullary arteriovenous fistula: clinicalfeatures and endovascular treatments.Journal of neurointerventional surgery.2019, 11:411¿415.Doi: 10.1136/neurintsurg-2018-014184. the purpose of this article was to summarize the clinical features of pediatric pmavfs and our clinical experience in their treatment and to evaluate the effect of endovascular treatment in a large cohort.The authors reviewed 51 cases of patients treated for pediatric spinal perimedullary arteriovenous fistula (pmavf) using marathon and echelon-10 catheters.Of the 51 patients, the average age was 6 years, 13 were female and 38 were male.One patient suffered from a treatment-related complication, which was caused by thrombosis of the draining vein after the complementary microsurgery.The patient¿s symptoms were markedly aggravated after surgery (mals increased from 2 to 9) but were resolved almost completely in the 7-year follow-up (mals decreased to 1). the study found pediatric pmavf is a special subgroup of intradural arteriovenous shunt that has a high disability rate and should be diagnosed and treated early.Endovascular embolization is safe and effective in the treatment of pediatric pmavfs. the article does not state any technical issues during use of the catheters. the following intra- or post-procedural outcomes were noted: thrombosis.
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Manufacturer Narrative
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Li j, zeng g, zhi x, bian l, yang f, du j, ling f, zhang h.Pediatric perimedullary arteriovenous fistula: clinical features and endovascular treatments.Journal of neurointerventional surgery.2019, 11:411¿415.Doi: 10.1136/neurintsurg-2018-014184. 6 years is the average age of the patients who used solitaire devices in the study.Refer to regulatory rep #: 2029214-2022-01345 for related event information.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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