Film evaluation summary: analysis of the returned films revealed the presence of contrast leakage in the aneurysm sac.The subtype and cause of the endoleak could not be conclusively determined.Endoleak interrogation via selective angiograms (i.E., injecting contrast from several levels within the stent graft) , to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point was available in the films provided; thereby, making determination of the endoleak difficult.Complete post-implant ct's could allow for a more through assessment of the stent graft in vivo configuration.It is possible that this was a type ia endoleak due to a lack of proximal seal , but this could not be confirmed as only a lateral view of the thoracic aorta was provided.There appeared to be incomplete radial stent apposition between the proximal valiant captivia and the non-medtronic stent graft for approximately 2 stent rings in the overlapping area.Despite the lack of complete expansion, patency was observed throughout the length of the implanted stent grafts.The observed endoleak did not appear to originate in this area.The cause of the incomplete expansion could not be determined.Angiogram videos showing the deployment of the stent grafts were not available for a thorough assessment of the observed event.Analysis of the returned films did not reveal any apparent stent graft integrity issues.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.
|